The Canadian Cardiac Chronicle Fall 2014
Volume 18, No. 3
Expeditions in Clincial Research Under 160 years ago, Sir John Franklin lead an expedition, sailing from England with two ships to find the elusive Northwest Passage. Their purpose was simple - find a trade route to Asia that was faster (and therefore more lucrative) which would provide England with greater access to markets. What transpired in the icy arctic waters is in part history and in part mystery. Until early September of this year, the ships had not been found since they got trapped in the ice in Canadian waters, with all aboard perishing. Meticulous searching, some serendipity and careful mapping of the ocean floor identified one of the ships, perfectly preserved, just 11 meters underwater. How does the legend of Sir John Franklin’s expedition relate to clinical research? In many ways, the expedition is similar to a clinical trial. The idea and concept to find a new way forward drove the expedition to plan and execute the voyage, often based on little information due to the very uncertainty of the arctic. Similar to clinical trials, the initial attempts to improve human health do not always transpire as planned, and may have results that require further understanding to guide the path forward. Ignoring the lessons learned about the expedition’s demise would have been foolhardy – others may have done the exact same experiment with the same results. Modifying a plan based on further information accrued during research is similar to an expedition changing direction or alternatively, the next expedition team taking a different pathway. Recent examples of clinical trials require reflection upon what we have collectively learned from our own expeditions in clinical research. The REGULATE-PCI trial, using a novel aptamer technology for patients with acute coronary syndromes to turn anti-coagulation on and off like a light switch, recently stopped early due to concerns over allergy. Early experience with the study drug in early phase trials (prior expeditions) had lead to increased surveillance to ensure patient safety. Unfortunately, this promising concept and the trial designed to test its efficacy has stopped– despite the hard work of the study teams at each site, the scientists who developed it, and the academic and industry partners who designed the appropriately cautious but forward thinking clinical trial. There is much to learn from REGULATE, and due to the hard
The CVC is proud to be a University of Alberta Centre
In This Issue: Letter - Justin Ezekowitz 1 Trial Updates 2-7 A Study Coordinator’s Perspective on Health Canada Inspections - Kim Robbins., York PCI 7 CVC News 7 Publications 8 work of each Canadian clinical site, the volunteer spirit of patients enrolled in the trial and the rich set of data collected, it is unlikely this is the last lesson we have learned from this trial. Secondary analysis of clinical trials is another method by which we understand how a new medication works, the natural history of a disease, the effect of standard therapies and often inform the design of the next experiment. The Franklin expedition led to mapping of thousands of miles of our Canadian maritime border and the eventual discovery of the Northwest passage. Similarly, an acute heart failure trial study conducted in Canada with your help – ASCEND-HF – was and remains the largest trial of its type, and re-defined the way clinical trials in acute heart failure are done. Many of you are involved in a phase 2 trial (BLAST-HF) testing a new designer molecule is modeled after the experience of ASCEND-HF. We look forward to learning more in this challenging syndrome and toward eventual therapeutic advances. The many, many trials and accomplishments reflected in this edition of the Chronicle are due to the hard work and dedication of the entire team here at CVC, at your site and with our partners across Canada and world. Let’s continue to work together to design and execute clinical trials and observe the clues that sometimes lie just beneath the water. Join us in Vancouver at the Canadian Cardiovascular Congress in October at the Beyond 2000 symposium (www.beyond2000.org) and learn more about the recent advances in Acute Coronary Syndromes. - Justin Ezekowitz
The Canadian Cardiac Chronicle - Volume 18
ODYSSEY OUTCOMES Our Canadian sites have truly put in a fantastic effort over the summer months. Thanks to these efforts, Canada was able to set a new randomization record in the month of July, with a total of 17 patients randomized. Congratulations! Worldwide, the ODYSSEY Outcomes trial has now screened over 14,000 patients. In Canada, our 34 active sites have contributed with almost 300 patients screened and nearly 100 randomized.
• PI Eric Sabbah – SC Isabelle Chaussé – 6 Patients Randomized in 2014 • PI Daniel Savard – SC Gina Vincelli – 5 Patient Randomized in 2014
We continue to encourage you to make full use of the added flexibility that Amendment 6 provides. The extension of the ACS to randomization window, as well as the possibility of re-screening patients, are two great examples of new patient groups that sites can and should be exploring! As always, please ensure that you continue to submit your pre-screening logs to CVC weekly.
We encourage you to make every effort to attend our monthly Canadian Update WebEx sessions. We welcome your suggestions and feedback, and look forward to your participation on these calls. If there are any topics you would like us to discuss or any training you feel would be useful, please let us know.
Congratulations to our top screening sites of 2014 (data as of 4Sept2014): • PI Jan Kornder – SC Dale Kastanis – 20 Patients Screened in 2014 • PI Daniel Savard – SC Gina Vincelli – 17 Patients Screened in 2014 • PI Manahora Senaratne – SC Bernadette Fernando – 11 Patients Screened in 2014 • PI Eric Sabbah – SC Isabelle Chaussé – 10 Patients Screened in 2014
Thank you for your support of the ODYSSEY Outcomes trial. Your efforts have not gone unnoticed!
As many of you are aware, very encouraging data was presented at the European Society of Cardiology congress this August, as nine additional phase 3 Odyssey trials met their primary efficacy endpoint. With that in mind, let us continue to search for and recruit patients into this exciting and very important trial! We are still recruiting a few final sites for this study. Should you be interested in hearing more about ODYSSEY or have questions regarding the trial, please contact Clinical Trials Project Lead Amanda Carapellucci at 1-800-707-9098 (ext. 2) or by email at amanda.carapellucci@ualberta.ca or Paula Priest (ext. 9) or paula.priest@ualberta.ca.
And our top randomizing sites of 2014: • PI Manahora Senaratne – SC Bernadette Fernando – 9 Patients Randomized in 2014 • PI Jan Kornder – SC Lynn Breakwell/Dale Kastanis – 7 Patients Randomized in 2014 • PI Simon Kouz – SC Madeleine Roy – 7 Patients Randomized in 2014
Sponsored by Sanofi-aventis Recherche & Développement this is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effect of SAR236553/REGN727 on the occurrence of cardiovascular events in patients who have recently experienced an Acute Coronary Syndrome. ClinicalTrials.gov Identifier: NCT01663402
PROACT With enrollment over 80% complete in PROACT we are pleased to see the ongoing enthusiasm and enrollment from the Edmonton Emergency Medical Service paramedics. Their dedication to this project and the continuing support of the Supervisor and the VESST staff at EMS has been invaluable. Keep up the great work. 100 patients to go! We are in the process of preparing for our upcoming Steering Committee meeting the 3rd week of October and to that end are busy ensuring all data on patients enrolled to date is collected, entered and adjudicated. For further information please contact Paula Priest at 1-800707-9098 (ext 9) or email at paula.priest@ualberta.ca .
Providing Rapid Out of Hospital Acute Cardiovascular Treatment
PROACT
An Edmonton-region local initiative sponsored by the University Hospital Foundation and the Mazankowski Alberta Heart Institute. Additional support for point of care meters provided by Alere Inc. ClinicalTrials.gov Identifier: NCT01634425
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The Canadian Cardiac Chronicle - Volume 18
IMPROVE-IT We are in the final stretch of this 9 year trial! The Final Timeline for Study Closeout (Memo #414) was sent to sites on August 13, 2014. Two areas of focus at this point in the trial are finding LTFU patients and database cleaning. More than ever, regulatory agencies are requiring at minimum a vital status on all LTFU patients. Ideally, for IMPROVE IT, we would like to have a Last Known Alive Date in 2014, or a Deceased Date – either of which is preferable to a status of “Unknown”, and is critical information to have in a trial. In Canada, 4 LTFU patients have been found thanks to the hard work of the affected sites. Now that all Final Visits (phone, clinic) have been completed and entered in the database, we must focus on cleaning the data. With database lock expected to occur in October, CVC will continue to notify sites of their data status until then. Canada’s data is in very good shape overall, aside from a few one-off requests for outstanding queries to be resolved. Until the database is locked, sites are expected to have staff available to answer any queries or enter any data corrections within 1 business day – please let your Project Lead know of any planned absences of the study coordinator or PI at your site.
close their site with their REB. It will be the end of an era to no longer be actively working on IMPROVE IT. Thanks to all of our sites for their hard work and contribution to this important trial, not to mention their patience and stamina in doing so. It has been a pleasure working with all of you on this trial and we look forward to sharing the results with you in the near future! We anticipate the study will be presented at the American Heart Association in Chicago this November and will be sure to keep you up to date. For further information, please contact Clinical Trial Project Lead, Jodi Parrotta at 1-800-707-9098, ext. 3 or by email at jodi. parrotta@ualberta.ca . IMProved Reduction of Outcomes: Vytorin Efficacy International Trial Sponsored by Merck & Co. Inc (previously ., Schering- Plough Research Institute) this trial is a multicenter, double-blind, randomized study to establish the clinical benefit and safety of Vytorin (ezetimibe/simvastatin Tablet) vs. simvastatin monotherapy in high-risk patients presenting with acute coronary syndrome.
Following database lock, and after the PI has signed the eCRF page, sites will be notified by the Project Lead when they can
ClinicalTrials.gov Identifier: NCT00202878
AEGIS-I In August the Safety Lead-In phase on the study commenced with the first patient recruited in Hungary. We are looking forward to the completion of this phase later this year and having our Canadian sites actively participating in the main phase of the study early in 2015. To that end we are now actively working through the final site selection visits and start-up with our sites. Despite a few delays we are well positioned to move forward in Canada now with ethics submissions and contract negotiations and anticipate a number of our sites will be ready to move into the main phase of the study on time.
As our sites are aware, Andreia Moretzsohn who has been helping out on this study will be transitioning off the study and Courtney Gubbels who is returning from a maternity leave will be your new contact and the primary Clinical Trial Project Lead on this study moving forward. For further information, please contact Clinical Trial Project Lead, Courtney Gubbels at 1-800-707-9098 or by email at courtney.gubbels@ualberta.ca.
The North America – Investigator Meeting (IM) is expected to happen in January/February 2015. We will be updating our sites in the near future so they can mark their calendars once a date has been confirmed. Page 3
Sponsored by CSL Behring LLC, this study is a Phase 2b, multicenter, rand o m i ze d , p l a c e b o - co nt ro l l e d , dose-ranging study to investigate the safety and tolerability of multiple dose administration of CSL112 in subjects with acute myocardial infarction.
The Canadian Cardiac Chronicle - Volume 18
EXSCEL The EXSCEL trial continues to move ahead and has now enrolled over 11,000 patients worldwide. Canada’s 24 active sites have been able to contribute with almost 500 patients – we look forward to seeing that number increase, especially as our new sites begin recruiting over the month of September! A special thank you to our top 2 recruiting sites – these sites are responsible for nearly 1/5 of Canada’s total recruitment for this study! • PI Ronald Bourgeois – SC Karen Boyd – 44 Patients Enrolled • PI Francois Dubé – SC Marilène Bolduc – 41 Patients Enrolled We would also like to congratulate our top 5 recruiting sites of 2014 (data as of Sept 04, 2014): • PI Francois Dubé – SC Marilène Bolduc – 19 patients enrolled in 2014 • PI Zubin Punthakee – SC Irene Stanton – 9 patients enrolled in 2014 • PI Steven Cheung – SC Tracy Cleveland – 6 patients enrolled in 2014 • PI Robin Kuritzky – SC Sandi Thiessen – 6 patients enrolled in 2014 • PI Yves Robitaille – SC Christine Masson – 5 patients enrolled in 2014 We truly appreciate your determination in continuing to screen and enroll patients into the EXSCEL trial! Our sites continue to do a tremendous job in terms of patient retention! If you come across a situation where a patient no longer wishes to participate in the trial, please ensure you inform your Project Lead and review all possible methods of follow up. Sites were also sent the “Patient Retention and Lost to Follow Up Log” which should be used to document all attempts made to contact patients who may potentially be lost to follow up. If you require any guidance, or need assistance to complete and update InForm, please reach out to your Project Lead.
Many of our sites are now working under Amendment 5, and we are certain that you are enjoying the new patient materials and recruitment tools! All sites have received their first shipment of glucose meters and strips – as these are distributed to patients, please be sure to record the serial number of the meter in your source documents. Note that these should only be given to patients who have been re-consented on your site-specific, REB approved, Amendment 5 ICFs. As a reminder, the glucose meters and supplies will be re-supplied every 6 months We are excited to announce that the database to capture EXSCEL Screen Failure patients is now completed! We will be hosting a Canada-wide WebEx session in the near future to go over the details of the program and to train all sites on how to use it. Stay tuned as an email with more information will be coming your way soon. Effective, September 23, 2014, Courtney Gubbels will be returning from a maternity leave and will be transitioning back onto this project as the Primary Clinical Trial Project Lead. At this time Amanda Carapellucci will begin transitioning off the project. We appreciate all Amanda’s hard work and support on this project through the last year and are happy to have her with us fully supporting the ODYSSEY study moving forward. Welcome back Courtney. If you would like further information on the EXSCEL trial, please contact Clinical Trials Project Lead Courtney Gubbels at 1-800707-9098 or by email at courtney.gubbels@ualberta.ca or Diane Camara at 1-800-725-6585 or by email at dcamara@ chrc.net.
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Exenatide Study of Cardiovascular Event Lowering Sponsored by Bristol-Myers Squibb, this trial is a pragmatic, long term, placebo- controlled, double-blinded trial which seeks to characterize the effects of exenatide once weekly on cardiovascular(CV) -related outcomes in patients with type 2 diabetes when added to the current usual care for glycemic control in a standard care setting. ClinicalTrials.gov Identifier: NCT01144338
The Canadian Cardiac Chronicle - Volume 18
TECOS been following up with many of our sites and will continue to do so prior to your site having a final monitoring visit and closeout. Again we appreciate your help to turn these requests around quickly. Also a reminder to send in your ethics submission as well as acknowledgement letters for SUSARS.
After 6 years of working together we are now nearing the finish line on TECOS. We appreciate our sites continued dedication and support as we work toward closeout. It was terrific to see everyone meet the tight timelines for final patient visits just prior to the summer. Overall our data is in great shape in Canada with 99% of it entered and clean. Hats off to everyone who has consistently helped to keep Canada at the top! As data cleaning continues over the next few months we ask that all our sites continue to keep a close eye on the database for any open queries and respond as quickly as possible to these as well as requests from the project team. For our sites with withdrawn of consent or lost to follow up patients please continue to make every effort to obtain a vital status on these patients. Every patient counts so we want this effort to continue until the database is locked.
If you have not already received a call from your onsite monitor, Joyce, Marie-Hélène or Halina they will be in contact with you in the near future to schedule a date for a final visit at your site in preparation for closure between October and January. Please work with them to get this on your calendar and ensure that your documentation (regulatory, drug accountability, delegation, data, etc) is complete and in good order prior to them coming on site so that they can cover everything off in that final visit. If you have any questions please don’t hesitate to contact Tracy Temple, Assistant Director – Clinical Trials and acting Project Lead at 1-800-707-9098 Option 5/tracy.temple@ualberta.ca or Kalli Belseck, Regulatory Specialist at 1-800-707-9098/kalli@ ualberta.ca. Sponsored by Merck & Co. Inc., TECOS is a Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control.
Of course as we prepare for closeout on the study, we are working hard to reconcile your site regulatory files. Kalli has
ClinicalTrials.gov Identifier: NCT00790205
SODIUM-HF The SODIUM-HF trial has 9 active sites – the last few Canadian sites will be activated in the next month with a few more sites potentially coming on board later in the fall! There are currently 19 patients enrolled in the trial – thanks to all sites who have enrolled patients. If you are experiencing any challenges in recruitment, please contact the Project Lead to discuss your concerns. A Rejuvenation Teleconference is scheduled for September 25 and 26 – all trial personnel at your site are welcome to attend. During the call we will review study status, answer questions from sites, and discuss patient enrollment / retention strategies. This meeting will also simultaneously be the first Dietitians’ Working Group meeting. Please attend, ask questions and share your site’s recruitment strategies! The teleconference invitation, with dial-in information, is forthcoming from CVC.
are setting a high bar and we appreciate your ongoing support of this trial. Please note: completed and verified 3-day food records should be submitted within three business day of the study visit to sodium-corelab@ualberta.ca. The core lab will analyze the food record and enter the nutritional results, including dietary sodium intake, on the ‘Dietary Intake’ form in the eCRF. This information may be used by site dietitians at study visits to coach participants who are randomized to the low-sodium arm. If you are interested in further information about SODIUM-HF, please contact Clinical Trial Project Lead Melisa Spaling at 780-492-8476 or via email at mspaling@ualberta.ca.
Congratulations to Dr. Howlett’s, Dr. McKelvie’s, Dr. Rajda’s, and Dr. Zieroth’s teams on your recent site activation – we look forward to seeing your first patient enrolled!
Funded by the Canadian Institute of Health Research (CIHR), SODIUM-HF is a multicenter, randomized, open-label Study Of DIetary Intervention Under 100 MMOL in Heart Failure.
Congratulations to Dr. Ross, Lisa Garrard and Margaret Brum on enrolling 13 patients since being activated on April 30! You
ClinicalTrials.gov Identifier: NCT02012179
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The Canadian Cardiac Chronicle - Volume 18
GUIDE-IT We have exciting news - Canada enrolled our 40th GUIDE-IT subject in early September! Thank you to all Investigators and Coordinators in achieving this milestone. Current trial enrollment is now 391 subjects (Canada has enrolled 41 subjects) and we hope to achieve another milestone by randomizing patient 400 in September! Please continue with your screening efforts to meet this goal and contact the Project Lead if your site is encountering any barriers to recruitment. Congratulations to Dr. McKelvie, Barb Miller and Lydia Morrow at Hamilton Health Sciences for enrolling 2 patients in 24 hours! Congratulations to Dr. Virani and Naomi Uchida for randomizing that elusive 2nd subject this past summer! We look forward to seeing more patients enrolled at your site. Thank you to all Study Coordinators for your diligence in preparing for the September 15 data cut. Please continue to keep a close eye on your data to ensure Canada continues to achieve excellent data entry and query resolution rates. Inform Tips and Reminders:
• As per the Scheduled of Study Assessments, DNA samples for the core lab are only collected once at the baseline visit (if the patient consents to DNA collection as per the SPECCONS page). Therefore, there should be zero “whole blood, EDTA” cryovials entered at all following study visits. • Please ensure the number of cryovials collected at each appropriate visit is entered into Inform and documented in source documents (including if zero cryovials collected). Our Edmonton and Calgary sites will be activated on the ECHO sub-study this fall. We look forward to having them participating in this exciting sub-study! For further information, please contact Clinical Trial Project Lead Melisa Spaling at mspaling@ualberta.ca or direct: 1-780492-8476. In collaboration with DCRI (Duke Clinical Research Institute) and Roche GUIDE-IT is a prospective, randomized 1:1, multi-centre clinical trial GUIDing Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.
• The PI is required to review and electronically verify all SAE’s and AE’s of interest entered in Inform (the PI verification is question 13 on the AE page). Please ensure these are verified when data entry for each SAE / AE has been finalized.
ClinicalTrials.gov Identifier: NCT01685840
BLAST-AHF Please ensure this is submitted to your ethics board for review and approval if you have not already done so. Please also remember to submit any serious adverse event notifications to your ethics committee and to forward all submissions, acknowledgement and approval letters to CVC! If your REB has specific guidance on submitting safety reports, please forward this documentation to CVC.
We are preparing to activate four sites for the BLAST-AHF trial with an aim to have Canada’s first patient enrolled in October 2014! If you are a participating site, thank you for your ongoing efforts in getting through start-up quickly – we will continue to work closely with you over the coming months. Valerie Carr will be the monitor for all participating sites in Canada. Should she contact you to arrange an on-site visit please connect with her as soon as possible to arrange a mutually convenient time and date!
The BLAST-AHF study is a Phase 2b trial that will enroll up to 500 adult subjects, across 80 sites globally, to evaluate the safety and efficacy of TRV027 on symptoms of acute decompensated heart failure when administered in addition to standard of care. If you are interested in further information about BLAST-AHF, please contact Clinical Trial Project Lead Melisa Spaling at 780-492-8476 or via email at mspaling@ ualberta.ca
Protocol version 2.1 (dated 29 August 2014) was recently released by the Sponsor and sent to all participating sites. Page 6
Sponsored by Trevena Inc., BLAST-AHF is A Randomized, Double-Blind, PlaceboControlled, Dose Ranging Study to Explore the Efficacy of TRV027 in Patients Hospitalized for Acute Decompensated Heart Failure. ClinicalTrials.gov Identifier: NCT01966601
The Canadian Cardiac Chronicle - Volume 18
REGULATE-PCI Following the recommendation of the DSMB, on August 24, 2014, the Executive Committee decided to close the trial due to allergic events that occurred in the study. Though we are disappointed in the premature closure of the study, there is still much to be learned from the data as well as understanding the potential role of actively reversible anticoagulation in the future. We are appreciative to our 18 Canadian sites who participated in the study and of those the 13 sites who contributed to the impressive 288 patients recruited in Canada.
the trial. Your continued support in these final stages of REGULATE-PCI close out is greatly appreciated. For further information, please contact Clinical Trial Project Lead, Jodi Parrotta at 1-800-707-9098, ext. 3 or by email at jodi. parrotta@ualberta.ca. Sponsored by Regado Biosciences Inc. this is a randomized, open-label, multi-center, active-controlled, parallel group study to determine the efficacy and safety of the REG1 Anticoagulation System Compared to Bivalirudin in Patients Undergoing Percutaneous Coronary Intervention.
We must now focus on working towards a quick and efficient close-out and as our sites are already aware we will be actively working to close their site in the coming weeks. We’d like to thank all of our sites for their enthusiasm and commitment to
Clinical trials.gov Identifier: NCT01848106
A Study Coordinator’s Position on Health Canada Inspections At anytime having a Heath Canada Inspection is stressful, but what if your leaving for vacation in two days, the inspector calls and will arrive your first day back from vacation; this is just a reminder of the importance of being ready at all times for an Inspection. Of course having a monitor who would remind me at every visit “It’s not if, but when you have an inspection”. During our Heath Canada Inspection I was reminded of a few things: 1. The Health Canada Inspection reinstilled the importance of documentation. Although we hear it and do it, sometimes you get lazy about it...it is so important to document, document, document! 2. Having a PI or Co-PI who is available/drops in throughout the inspection was extremely important. Giving the inspector confidence that there is clear evidence of physician involvement. 3. Ensuring data is entered according to the sponsors requested timelines. I was surprised when he asked me to
Written By Kim Robbins, York PCI
check the audit trail to see when the data was entered. The importance of having the physician sign off on SAEs is also important. Even though it was clear the physician was involved, you must have him sign documents in a timely matter. 4. Ensure that all temperature logs are fully completed; a missed initial is a finding! 5. Ensure all SOPs are up to date and accurate. 6. Ensure there is documentation of all research staff members’ GCP and Division 5 training and it is ongoing. As members of the research team, we need to remember that every drug and device that is approved, every treatment that is changed due to the research we do, impacts many patients and families in our communities now and for years to come. I know that Health Canada Inspections are stressful, but we were reminded of the importance of our research and always learn lessons which help us improve our research data. Providing the highest quality research data is one of our site’s missions.
CVC News Devon Blanchette joined the CVC in July 2014 as the new Administrative Assistant. Devon has recently relocated from Ottawa and joins CVC with a host of administration, pharmaceutical and health research experience. In her spare time, she pursues her background in photography and graphic design and enjoys traveling.
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The Canadian Cardiac Chronicle - Volume 18
Publications Bainey KR, Gafni A, Rao-Melacini P, Tong W, Steg PG, Faxon DP, Lamy A, Granger CB, Yusuf S, Mehta SR; TIMACS Investigators. The cost implications of an early versus delayed invasive strategy in Acute Coronary Syndromes: the TIMACS study. J Med Econ. 2014 Jun;17(6):415-422. http://www.ncbi.nlm.nih.gov/pubmed/24702256 Bao MH, Zheng Y, Westerhout CM, Fu Y, Wagner GS, Chaitman B, Granger CB, Armstrong PW. Prognostic implications of quantitative evaluation of baseline Q-wave width in ST-segment elevation myocardial infarction. J Electrocardiol 2014 Jul-Aug;47(4):465-471. http://www.ncbi.nlm.nih.gov/pubmed/24853083 Bushnik T, Levallois P, D’Amour M, Anderson TJ, McAlister FA. Association between blood lead and blood pressure: Results from the Canadian Health Measures Survey (2007 to 2011). Health Rep 2014 Jul 16;25(7):12-22. http://www.ncbi.nlm.nih.gov/ pubmed/25029492 Dianati Maleki N, Van de Werf F, Goldstein P, Adgey JA, Lambert Y, Sulimov V, Rosell-Ortiz F, Gershlick AH, Zheng Y, Westerhout CM, Armstrong PW. Aborted myocardial infarction in ST-elevation myocardial infarction: insights from the STrategic Reperfusion Early After Myocardial infarction trial. Heart 2014 Oct 1;100(19):1543-1549. http://www.ncbi.nlm.nih.gov/pubmed/24916050 Ezekowitz JA, Becher H, Belenkie I, Clark AM, Duff HJ, Friedrich MG, Haykowsky MJ, Howlett JG, Kassiri Z, Kaul P, Kim DH, Knudtson ML, Light PE, Lopaschuk GD, McAlister FA, Noga ML, Oudit GY, Paterson DI, Quan H, Schulz R, Thompson RB, Weeks SG, Anderson TJ, Dyck JR. The Alberta Heart Failure Etiology and Analysis Research Team (HEART) study. BMC Cardiovasc Disord. 2014 July 25;14(1):91. http://www.ncbi. nlm.nih.gov/pubmed/25063541 Hess N, Row M, Gibson M, Temple R, Pencina M, Zarin D, Anstrom K, Alexander J, Sherman R, Fiedorek F, Mahaffey K, Lee K, Chow S, Armstrong PW, Califf R. Independent data monitoring committees: Preparing a path for the future. Am Heart J 2014 Aug;168(2):135-141. http://www.ncbi.nlm.nih.gov/pubmed/25066551 Kaila KS, Norris CM, Graham MM, Ali I, Bainey KR. Long-term survival with revascularization in South Asians admitted with an acute coronary syndrome (from the Alberta Provincial Project for Outcomes Assessment in Coronary Heart Disease Registry). Am J Cardiol. 2014 Aug 1;114(3):395-400. http://www.ncbi.nlm.nih.gov/ pubmed/24927971
Mehta RH, Westerhout CM, Zheng Y, Giugliano RP, Huber K, Prabhakaran D, Harrington RA, Newby KL, Armstrong PW; EARLY ACS Investigators. Association of metabolic syndrome and its individual components with outcomes among patients with high-risk non-ST-segment elevation acute coronary syndromes. Am Heart J 2014 Aug;168(2):182-188. http://www.ncbi.nlm.nih.gov/pubmed/25066557 Quan H, McAlister FA, Khan N. The many faces of hypertension in Canada. Curr Opin Cardiol 2014 Jul;29(4):354-359. http://www.ncbi.nlm.nih.gov/pubmed/25029453 Sidhu RS, Youngson E, McAlister FA. Physician continuity improves outcomes for heart failure patients treated and released from the emergency department. JACC Heart Fail 2014 Aug;2(4):368-376. http://www.ncbi.nlm.nih.gov/pubmed/25023815 Valgimigli M, Tricoci P, Huang Z, Aylward P, Armstrong PW, Van de Werd F, Leonardi S, White HD, Widimsky P, Harrington RA, Cequier A, Chen E, Lokhnygina Y, Wallentin L, Strony J, Mahaffey KW, Moliterno DJ. Usefulness and Safety of Vorapaxar in Patients With Non-ST Segment Elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention (from the TRACER trial) Am J Cardiol 2014 Sep 1(5);114:665-673. http://www.ncbi.nlm.nih.gov/pubmed/25129064 van Deursen VM, Hernandez AF, Stebbins A, Hasselblad V, Ezekowitz JA, Califf RM, Gottlieb SS, O’Connor CM, Starling RC, Tang WH, McMurray JJ, Dickstein K, Voors AA. Nesiritide, renal function, and associated outcomes during hospitalization for acute decompensated heart failure: Results from ASCEND-HF. Circulation 2014 Sep 16;130(12):958-965. http://www.ncbi.nlm.nih.gov/pubmed/25074507 van Diepen S, Youngson E, Ezekowitz JA, McAlister FA. Which risk score best predicts perioperative outcomes in nonvalvular atrial fibrillation patients undergoing noncardiac surgery? Am Heart J 2014 Jul;168(1):60-67.e5. http://www.ncbi.nlm. nih.gov/pubmed/24952861 Welsh RC, Van de Werf F, Westerhout C, Goldstein P, Gershlick AH, Wilcox RG, Danays T, Bluhmki E, Lopes RD, Steg PG, Armstrong PW. Outcomes of a pharmacoinvasive strategy for successful versus failed fibrinolysis and primary percutaneous intervention in acute myocardial infarction (from the STrategic Reperfusion Early After Myocardial Infarction [STREAM] Study) Am J Cardiol 2014 Sep 15;114(6):811819. http://www.ncbi.nlm.nih.gov/pubmed/25108302
Lyons KJ, Podder M, Ezekowitz JA. Rates and reasons for device based guideline-eligibility in patients with heart failure. Heart Rhythm 2014 Aug 4. pii: S15475271(14)00858-3. http://www.ncbi.nlm.nih.gov/pubmed/25101484
Publication Information This newsletter is published periodically as a service to Canadian investigational sites. The purpose is to provide information of interest to individuals involved in cardiovascular clinical trials managed by the Canadian VIGOUR Centre, University of Alberta in Edmonton, Alberta, Canada. The VIGOUR (Virtual CoordInating Centre for Global COllaborative CardiovascUlar Research) group is an international academic group committed to advancing cardiovascular medicine and enhancing patient care worldwide. Its membership includes: the Canadian VIGOUR Centre (CVC), University of Alberta, Edmonton, Alberta, Canada; Green Lane Coordinating Centre, Auckland, New Zealand; National Health & Medical Research Council – Clinical Trials Centre, Sydney, Australia; Flinders Medical Centre, Bedford Park, Australia; Duke Clinical Research Institute (DCRI), Duke University, Durham, NC, USA; Leuven Coordinating Centre, University Hospital Gasthuisberg, Leuven, Belgium; ECLA, Rosario, Argentina, South America; TANGO, Buenos Aires, Argentina, South America; Uppsala Clinical Research Centre, Uppsala, Sweden
CVC gratefully acknowledges our sponsors and the funding support provided by: Alere Inc. Amgen AstraZeneca Boehringer Ingelheim Bristol-Myers Squibb CSL Behring LLC Hoffmann-La Roche Merck & Co., Inc.
Address for Inquiries: 2-132 Li Ka Shing Centre for Health Research Innovation University of Alberta, Edmonton, AB, Canada, T6G 2E1 Phone: 1-800-707-9098, Fax: (780) 492-0613 www.vigour.ualberta.ca
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Regado Biosciences Inc. Roche Diagnostics Operations Inc. Sanofi-aventis Recherche & Développement Trevena Inc. Canadian Institute of Health Research Mazankowski Alberta Heart Institute University Hospital Foundation
Canadian Cardiac Chronicle Editorial Board: Paul W. Armstrong Kalli Belseck Amanda Carapellucci Justin Ezekowitz
Halina Nawrocki Jodi Parrotta Carla Price Paula Priest
Ellen Pyear Melisa Spaling Tracy Temple