The Canadian Cardiac Chronicle
The Canadian Cardiac
Chronicle Volume 23, Issue No. 1 Ask a simple question, get a complex answer We’ve all been there. Faced with a problem or situation, we step back and ask the simplest question, often to ourselves, and are astounded by either the lack of valid answer, or confronted by a very complex answer. That leaves us at a crossroads: do we try to answer the broader, simply-stated pragmatic question, or dive deep into the myriad of complexity that can come with breaking the question into a million little pieces? Clinical investigation thrives on answering questions that answer both broad, far-reaching and practical questions, as well as inquiry based on precise, focused and discovery-based questions. In medicine, the two approaches co-exist on a spectrum and are both needed, as no two situations are identical. There is often a tension that exists when we design an experiment – in our world often a clinical trial with an intervention – and have to make a series of decisions that could ultimately dictate how explanatory or pragmatic the trial (and results) will be to the patients, practitioners, policy-makers and payers.
To that end, we must continue to answer very explanatory questions, for example: does a short infusion of intravenous iron every 6 months, in patients with heart failure, reduce the risk of bad clinical outcomes? As this will apply to a specific population, under a specific situation, we may also wonder about broader questions for broader populations: are patients with an acute coronary syndrome managed equally well in a critical care unit or a regular cardiology ward? Answering each of the questions requires a different approach, a related but unique set of tools, and a committed investigative team and patient partners. In early March, the CVC brought together partners from Canadian clinical trial sites, industry partners, colleagues from the Duke Clinical Research Institute and patient representation. I would personally like to thank the participants as this was clearly a dynamic discussion made richer by frank discussions on how and why we do what we do. More about the colloquium is appended.
Indeed, the concept of translational medicine was initially built on discovery (“basic”) science developing a new potential biomarker or treatment, and then following forward in a number of precise experiments until it is tested in the largest of precise experiments – for example – a phase 3 trial. More recently, the observations made at the population level (and by patients), and with data science, have highlighted areas where discovery science should focus, and potential linkages not seen before – leading to translation from populations to benchtop.
As we consider the complexity of research, we should keep the 1977 Apple advertisement in mind “Simplicity is the ultimate sophistication”. Let’s work together, strive to simplify and provide sophisticated answers to simple questions.
The CVC is proud to be a University of Alberta Centre Page 1
Justin Ezekowitz CVC Co-Director
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CVC Clinical Trials Colloquium - Banff, AB
On March 10th, 2019, the Canadian VIGOUR Centre welcomed 17 sites from 6 different provinces to participate in the 6th Annual CVC Clinical Trials Colloquium in Banff, AB. A sincere thank you to our sponsors Amgen, AstraZeneca, BMS-Pfizer Alliance, Boehringer-Ingelheim, CSL Behring, Novartis and Sanofi for their support towards making this event possible!
Developing tools and methods to connect our research community/ network.
Sharing and gaining knowledge from past and current trials experiences in order to achieve success in all aspects – from start-up through to closeout – including quality and training.
Building upon objectives and key feedback from previous colloquia, the focus of this year’s meeting was to seek out new opportunities for enhancing clinical research, including:
Enhancing best practices in conducting clinical trials, through an open forum of discussions, breakouts and sharing. Looking at trial designs, research infrastructure, cost effectiveness and privacy challenges within the current clinical trial environment, and considering how we can continue to adapt and enhance trials within a changing research environment.
Learning from our patients and strategizing on successful ways to engage them in clinical trials conduct.
Led by our Associate Director of Clinical Trials, Tracy Temple, we conducted our morning introductions by sharing our local research infrastructures, and learned of the various types and sizes of research teams as well as the myriad of research settings within our Canadian network. Lisa Berdan, Director of Mega Trials at DCRI, along with CVC Co-Directors Dr. Shaun Goodman and Dr. Justin Ezekowitz, began the day by reviewing some of the biggest challenges we face in conducting clinical trials, which affect all types of research design and study populations. This session concluded with a lively ‘Cost and Compensation’ debate where we explored some considerations and challenges – both from the research site’s and sponsor’s perspective – in determining adequate trial budgets and fair compensation. In what was perhaps one of our most meaningful Colloquium topics to date, we were thrilled to welcome Mr. Ginter Hilbrecht, a current clinical trial research participant. Through his experience both as a research patient and representative of a study Patient Advisory Board affiliated with the DCRI and CSL Behring, Mr. Hilbrecht provided us a first-hand account of the research patient’s
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experience. From this invaluable patient perspective, we explored how to improve all aspects of trial design and conduct, with an aim to increase recruitment, minimize patient burden/concerns, keep patients engaged and committed to their trial participation, and ultimately optimize public awareness and perception of clinical research. We began our afternoon with another important aspect of promoting research in the community: involving community GPs in clinical trials. Our colleague, Dr. Scott Garrison, shared his experience as a community family physician and provided us insight into some of the barriers to implementing traditional trial designs within the family practice setting. Dr. Garrison shared his innovative work in pragmatic clinical trial design and conduct, including the use of technology across multiple provinces as a novel way to help streamline recruitment and foster patient engagement. We then turned our focus to training and the possibility of research site accreditation on the horizon. Our colleague, Ty Rorick, Interim Director, Industry Trials at DCRI, invited us to consider the pros and cons of accreditation, while noting site vs. institution requirements, country vs. global implications and, if implemented, whether this should be mandatory or voluntary. Closely related to accreditation is the topic of training and we examined the often daunting amount of training required in today’s research climate as well as the overlap that inevitably occurs across various trials and sponsors. We had a round-table deliberation about defining the minimum training requirements in order for sites to participate in clinical trials.
media, and various professional researchers’ organizations, all ranging from local to international in scope. We had a useful discussion that helped identify both the unmet needs experienced by our sites as well as an initial determination of which methods and tools might be valuable to develop in the future. We look forward to enhancing CVC’s current resources for sites based on the information collected. We wish to extend our appreciation to all investigators, coordinators, and sponsors who participated in this year’s gathering; their valuable experiences and contributions made this an engaging and unique event. While we can gather only a small group of sites to the Colloquium each year, our goal remains to continue learning from each of our sites how best to optimize the conduct and improve performance of clinical trials, as well as share key information within our entire network of sites. If you are interested in hearing more about this year’s meeting or would like to inquire about participation in a future Colloquium, please contact Tracy Temple at tracy.temple@ualberta.ca or 780-492-1876.
We closed our day with an innovative brainstorming session on how to build a research network and community. We learned more about which methods our sites currently use to stay connected to their research communities, including live conferences, trial-specific meetings, social
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Check out the highlights from the event here:
@CVC_UAlberta #CVCBanff
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STREAM-2 Globally there are 6 countries recruiting with an addi-
tional 4 countries coming on board very soon. The recent amendment to the protocol inclusion criteria has accelerated the number enrolled. Global enrollment is approaching 100 participants with a steady increase each month. Edmonton is currently the top recruiting site in the world with just over 20 participants enrolled! Amazing effort and collaboration by all the participating groups that continue to make this trial successful.
Gubbels at 1-800-707-9098 ext. 2 or via email at courtney.gubbels@ualberta.ca or Senior Regulatory Specialist Kalli Belseck, 1-800-707-9098 ext. 6 or via email at kalli@ualberta.ca.
Sponsored by Leuven Research & Development (LRD) at University of Leuven, Belgium, STREAM-2 is a Phase 4 trial on STrategic Reperfusion in elderly patients Early After Myocardial Infarction
If you are interested in further information regarding this trial, please contact Clinical Trial Project Lead Courtney
ClinicalTrials.gov Identifier: NCT02777580
SODIUM-HF Our ongoing thanks to all sites for your continued efforts in screening, enrolling and following patients for the SODIUM-HF trial! With 2/3 of enrolment complete, your enthusiasm is needed more than ever to get us to the finish line…every patient counts! If you have any suggestions, concerns or questions regarding increasing enrolment at your site, please reach out to Melisa Spaling (contact info below). Congratulations to the following sites on their recent success: • • •
SODIUM-HF Website and Twitter
1st patient randomized: Dr. Saldarriaga, Paola Marcela Tobon, Adriana Maria Agudelo Perez, Elsa Gonzalez Sanchez (Medellin, Colombia) Finding your groove and enrolling several patients in March: Dr. Lavoie, Jo-Anne Kurenoff, Kendra Townsend (Saskatchewan, Canada) Back at it!: Dr. Bourke, Romina Delgado (Orsono, Chile)
Don’t forget... the SODIUM-HF study has a trial website www.sodiumhftrial.com and twitter handle! Follow @sodiumhf for posts featuring site personnel and their accomplishments as well as other exciting study-related news. These platforms provide a different avenue for engaging with the SODIUM-HF operations team and other participating sites. Share your twitter handle and we will be sure to follow you!
Welcome to the following new sites: A warm welcome to the following sites. We look forward to continued strong enrolment from New Zealand! • •
Dr. Doughty, Mardi Heath - University of Auckland (Auckland, NZ) Dr. Lund, Renee Railton, Chaewoo Jun - Middlemore Clinical Trials (Auckland, NZ)
If you are interested in receiving more information about the SODIUM-HF trial, please contact the Clinical Trials Project Lead, Melisa Spaling, via email at mspaling@ualberta.ca or 1-800-707-9098, ext. 1 or Regulatory Specialist, Kate Dawson, via email at kedawson@ualberta.ca or 1-800-7079098, ext. 8.
Upcoming Independent Data Review: Please continue to address queries, submit source documents and enter data in a timely manner as we anticipate an upcoming DSMB meeting in the spring of 2019. Recommendations of the DSMB will be shared with sites as needed, when available.
Funded by the Canadian Institute of Health Research (CIHR) and University Hospital Foundation, SODIUM-HF is a multicenter, randomized, open-label Study Of DIetary Intervention Under 100 MMOL in Heart Failure.
ClinicalTrials.gov Identifier: NCT02012179
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The Canadian Cardiac Chronicle
AEGIS-II We are off to a very good start in 2019! The start-up phase of AEGIS-II in Canada is very close to complete with just two sites left to hit the very important milestone of site activation, bringing our total number of sites in Canada to 32.
the applicable sections of the protocol as well as the infusion eligibility tools very carefully prior to each infusion to avoid major protocol deviations. Your CVC team is always available for questions or clarifications as well.
Our focus is now shifting to enrollment and we are proud to see our sites’ enthusiasm and motivation to contribute to this important study come to fruition. Canada has hit the ground running in 2019 with enrollment numbers exceeding projections each month! Congratulations to the top three enrolling sites in Canada! • • •
As a reminder, the required time window for eCRF data entry is within 2 days of each visit, or within 24 hours for all Serious Adverse Events. Please ensure that you continue to enter data and answer open queries in a timely manner. Thank you to all of the sites that have worked hard to keep their data consistently clean! If you are interested in further information regarding this trial, please contact Clinical Trial Project Lead, Lyndsey Garritty at 1-800-707-9098, ext 8 or via email at lyndsey.garritty@ualberta.ca or Senior Regulatory Specialist Kalli Belseck, 1-800-707-9098 ext. 6 or via email at kalli@ualberta.ca.
Dr. Rodes-Cabau & Karine Maheux – IUCPQ (Quebec City, QC) 15 Patients Dr. Bainey & Norma Hogg – University of Alberta Hospital/Mazankowski Heart Institute (Edmonton, AB) 13 Patients Dr. Cheema & Khrystyna Kushniriuk – St. Michael’s Hospital (Toronto, ON) 11 Patients
Sponsored by CSL Behring LLC, this is a Phase 3, Multicentre, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of CSL112 in Subjects with Acute Coronary Syndrome.
Mastering the details surrounding the local and central labwork required for infusion eligibility has proven challenging for some sites, so we encourage you to review
ClinicalTrials.gov Identifier: NCT03473223
FEAST-HF Recruitment into the FEAST-HF pilot is nearly complete at the University of Alberta. We look forward to learning more about the potential health benefits of dietary fiber supplementation as well as new avenues for treatment and future research for patients with Heart Failure.
Lead, Karin Kushniruk, at 1-800-707-9098, ext. 7 or karin.kushniruk@ualberta.ca. Sponsored by University Hospital Foundation, FEAST-HF trial will explore the potential beneficial effects of dietary fiber supplementation, compared with placebo, in patients with Heart Failure
If you are interested in further information about the FEAST-HF trial, please contact the Clinical Trial Project
ClinicalTrials.gov Identifier: NCT3409926
VICTORIA-HF REGISTRY The VICTORIA-HF Registry completed its enrollment earlier this year and is currently in the final stages of Close Out. Thank you to our Canadian sites for a job well done! Many of our sites met their 50-patient target well ahead of schedule and we wish to thank each and every one of our sites for their excellent contribution to this important study.We look forward to sharing the results with you in the future.
VICTORIA Heart Failure Registry, please contact the Clinical Trial Project Lead, Karin Kushniruk, at 1-800-7079098, ext. 7 or karin.kushniruk@ualberta.ca or the Regulatory Specialist, Kate Dawson, at kedawson@ualberta.ca or 1-800-707-9098, ext. 8.
If you are interested in further information about the
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VICTORIA-HF Registry Sponsored by Merck and Bayer this registry will assess the risk/benefit profile of Vericiguat in those patients with chronic heart failure.
The Canadian Cardiac Chronicle
HEART-FID walk the entire 6 minutes. At bare minimum, they just need to attempt the walk. As a reminder, there is a 6MWT administration video created for guidance. If you have not already watched the video, please do so. CEC Box When submitting your source documents please remember to remove all personal health identifiers. Clearly label each page with your site number and the subject number. When uploading to Box, please ensure you upload to the HEART-FID CEC Inbox otherwise the CEC will be unable to review your documents. Please upload your source documents within 10 days of knowledge of the event or as soon as possible.
There was a big push over the past few months to increase global enrollment. Thank you to all our sites that are diligently looking for participants leaving no stone unturned. All your hard work is translating into an upward trend in B2K Webinar Series enrollment.
IND Safety Reports Review, sign, send and file! Please ensure you review the IND safety reports sent to you. After review, the PI is required to sign the report. Next, please send a copy of the signed report to the sponsor. Remember to write your site number on the report prior to sending. Send the report to your REB as per their reporting policy.
A special note of thanks to our Canadian top 3 enrolling sites: • • •
Dr. Pandey, Stephanie Buck and Patrick Toth – Cambridge Cardiac Care Centre (Cambridge, ON) Dr. Khosla and Tracy Cleveland – Surrey Memorial Hospital – Cardiology Clinical Trials (Surrey, BC) Dr. Swiggum and Sarah Nelson – Victoria Heart Institute (Victoria, BC)
If you are interested in further information regarding this trial, please contact Clinical Trial Project Lead Courtney Gubbels at 1-800-707-9098 ext. 2 or via email at courtney.gubbels@ualberta.ca or Regulatory Specialist Kate Dawson, 1-800-707-9098 ext. 8 or via email at kedawson@ualberta.ca.
Trial Reminders: 6 Minute Walk Test The 6MWT is very important as it is part of the primary and secondary endpoints for the trial. If your participant is off study drug or has just agreed to telephone calls, please still ask them to return to the clinic to complete the walk. It is better to complete the walk out of window than not at all. Also, remember the participant does not need to
B2K Webinar Series The Canadian VIGOUR Centre (CVC) and the Beyond 2018 (B2K18) educational program is pleased to host a Canadian Cardiovascular Society-accredited webinar series initiative that is being provided as an extension to the B2K18 symposium (held annually during the Canadian Cardiovascular Congress).The next webinar (Oral Antiplatelet Therapy Post-ACS) will be held on May 1, 2019. More details and recordings of previous webinars can be found on the CVC website: https://thecvc.ca/beyond-2000/webinar-series. Page 6
Sponsored by American Regent, HEART-FID is a Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure With Iron Deficiency ClinicalTrials.gov Identifier: NCT03037931
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Publications Berg DD, Bohula EA, van Diepen S, Katz JN, Alviar CL, Baird-Zars VM, Barnett CF, Barsness GW, Burke JA, Cremer PC, Cruz J, Daniels LB, DeFilippis AP, Haleem A, Hollenberg SM, Horowitz JM, Keller N, Kontos MC, Lawler PR, Menon V, Metkus TS, Ng J, Orgel R, Overgaard CB, Park JG, Phreaner N, Roswell RO, Schulman SP, Jeffrey Snell R, Solomon MA, Ternus B, Tymchak W, Vikram F, Morrow DA. Epidemiology of shock in contemporary cardiac intensive care units. Circ Cardiovasc Qual Outcomes. 2019;12:e005618
of use of targeted temperature management for acute myocardial infarction patients following out-of-hospital cardiac arrest: Insights from the National Cardiovascular Data Registry. Am Heart J. 2018;206:131-133
Bernier R, Al-Shehri M, Raj SR, Reyes L, Lockwood E, Gulamhusein S, Williams R, Valtuille L, Sivakumaran S, Hruczkowski T, Kimber S, Exner DV, Sandhu RK. A population-based study of adherence to guideline recommendations and appropriate-use criteria for implantable cardioverter defibrillators. Can J Cardiol. 2018;34:1677-1681
Gouda P, Ezekowitz JA. Update on the diagnosis and management of acute heart failure. Curr Opin Cardiol. 2018. doi: 10.1097
Brown PM, Ezekowitz JA. Frailty modelling for multitype recurrent events in clinical trials. Stat Model. 2019;19:140-156 Brusca SB, Barnett C, Barnhart BJ, Weng W, Morrow DA, Soble JS, Katz JN, Wiley BM, van Diepen S, Gomez AD, Solomon MA. Role of critical care medicine training in the cardiovascular intensive care unit: Survey responses from dual certified critical care cardiologists. J Am Heart Assoc. 2019;8:e011721 Cerrato E, Bianco M, Bagai A, De Luca L, Biscaglia S, Luciano A, Destefanis P, Quadri G, Meynet I, Gravinese C, Chinaglia A, Goodman SG, Pozzi R, Campo G, Varbella F. Short term outcome following acute phase switch among P2Y12 inhibitors in patients presenting with acute coronary syndrome treated with PCI: A systematic review and meta-analysis including 22,500 patients from 14 studies. Int J Cardiol Heart Vasc. 2019;22:39-45
Devrome AN, Aggarwal S, McMurtry MS, Southern D, Hauer T, Lamb B, Arena R, Moore RD, Wilton SB, Stone J, Martin BJ. Cardiac rehabilitation in people with peripheral arterial disease: A higher risk population that benefits from completion. Int J Cardiol. 2019; S0167-5273(19)30305-5 Du AX, Westerhout CM, McAlister FA, Shanks M, Oudit GY, Paterson DI, Hanninen M, Thomas J, Ezekowitz JA. The titration and tolerability of sacubitril/valsartan for patients with heart failure in clinical practice. J Cardiovasc Pharmacol. 2018 doi: 10.1097 Dyck GJB, Raj P, Zieroth S, Dyck JRB, Ezekowitz JA. The effects of resveratrol in patients with cardiovascular disease and heart failure: A narrative review. Int J Mol Sci. 2019 doi: 10.3390/ ijms20040904 Ezekowitz JA. Creating order out of chaos: Quality of care in heart failure. Heart Jnl. 2019 doi: 10.1136/heartjnl-2018-314526
Fordyce CB, Chen AY, Wang TY, Lucas J, Goyal A, Wong GC, van Diepen S, Kontos MC, Henry TD, Granger CB, Roe MT. Patterns
Hochman JS, Reynolds HR, Bangalore S, O’Brien SM, Alexander KP, Senior R, Boden WE, Stone GW, Goodman SG, Lopes RD, Lopez-Sendon J, White HD, Maggioni AP, Shaw LJ, Min JK, Picard MH, Berman DS, Chaitman BR, Mark DB, Spertus JA, Cyr DD, Bhargava B, Ruzyllo W, Wander GS, Chernyavskiy AM, Rosenberg YD, Maron DJ. Baseline characteristics and risk profiles of participants in the ISCHEMIA randomized clinical trial. JAMA Cardiology. 2019;4:273-286 Hohnloser SH, Fudim M, Alexander JH, Wojdyla DM, Ezekowitz JA, Hanna M, Atar D, Hijazi Z, Bahit MC, Al-Khatib SM, Lopez-Sendon JL, Wallentin L, Granger CB, Lopes RD. Efficacy and safety of Apixaban versus Warfarin in patients with atrial fibrillation and extremes in body weight: Insights from the ARISTOTLE trial. Circulation. 2019 doi: 10.1161 Hong Y, Graham MM, Southern D, McMurtry MS. The Association between chronic obstructive pulmonary disease and coronary artery disease in patients undergoing coronary angiography. COPD. 2019:1-6. doi: 10.1080/15412555.2019.1566894
Daubert MA, Adams K, Yow E, Barnhart HX, Douglas PS, Rimmer S, Norris C, Cooper L, Leifer E, Desvigne-Nickens P, Anstrom K, Fiuzat M, Ezekowitz J, Mark DB, O’Connor CM, Januzzi J, Felker GM. NT-proBNP goal achievement is associated with significant reverse remodeling and improved clinical outcomes in HFrEF. JACC Heart Fail. 2019;7:158-168
Fanaroff AC, Cyr D, Neely ML, Bakal J, White HD, Fox KAA, Armstrong PW, Lopes RD, Ohman EM, Roe MT. Days alive and out of hospital: Exploring a patient-centered, pragmatic outcome in a clinical trial of patients with acute coronary syndromes. Circ Cardiovasc Qual Outcomes. 2018 11:e004755
Gandhi S, Goodman SG, Greenlaw N, Ford I, McSkimming P, Ferrari R, Jang Y, Alcocer-Gamba MA, Fox K, Tardif JC, Tendera M, Dorian P, Steg G, Udell JA. Living alone and cardiovascular disease outcomes. Heart. 2019 doi: 10.1136
Lee H, Tan M, Yan AT, Angaran P, Dorian P, Bucci C, Gregoire JC, Bell AD, Green MS, Gross PL, Skanes A, Kerr CR, Mitchell LB, Cox JL, Essebag V, Heilbron B, Ramanathan K, Fournier C, Wheeler BH, Lin PJ, Berall M, Langer A, Goldin L, Goodman SG. Association between patient and physician sex and physician-estimated stroke and bleeding risks in atrial fibrillation. Can J Cardiol. 2019;35:160-168 Leung AA, Bushnik T, Hennessy D, McAlister FA, Manuel DG. Risk factors for hypertension in Canada. Health Rep. 2019;30:3-13. Li D, Weinkauf J, Hirji A, Kapasi A, Lien D, Nagendran J, Kim D, Ezekowitz J, Halloran K. Elevated pre-transplant left ventricular end-diastolic pressure increases primary graft dysfunction risk in double lung transplant recipients. J Heart Lung Transplant. 2019; S1053-2498(19)31391-9 Nazzari H, Hawkins NM, Ezekowitz J, Lauck S, Ding L, Polderman J, Yu M, Boone RH, Cheung A, Ye J, Wood D, Webb J, Toma M. The relationship between heart-failure hospitalization and mortality in patients receiving rranscatheter aortic valve replacement. Can J Cardiol. 2019;35:413-421 O’Connor C, Fiuzat M, Mulder H, Coles A, Ahmad T, Ezekowitz JA, Adams KF, Piña IL, Anstrom KJ, Cooper LS, Mark DB, Whellan DJ, Januzzi JL Jr, Leifer ES, Felker GM. Clinical factors related to morbidity and mortality in high-risk heart failure patients: The GUIDE-IT predictive model and risk score. Eur J Heart Fail. 2019 doi: 10.1002 Raggi P, Senior P, Shahbaz S, Kaul P, Hung R, Coulden R, Yeung R, Abele J. Sodium fluoride imaging of coronary atherosclerosis in ambulatory patients with diabetes mellitus. Arterioscler Thromb Vasc Biol. 2018 doi: 10.1161/ATVBAHA.118.311711
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Publications Sandhu RK, Ezekowitz JA, Hijazi Z, Westerbergh J, Aulin J, Alexander JH, Granger CB, Halvorsen S, Hanna MS, Lopes RD, Siegbahn A, Wallentin L. Obesity paradox on outcome in atrial fibrillation maintained even considering the prognostic influence of biomarkers: insights from the ARISTOTLE trial. Open Heart. 2018;5:e000908
Vanhaverbeke M, Bogaerts K, Sinnaeve PR, Janssens L, Armstrong PW, Van de Werf F. Prevention of cardiogenic shock after acute myocardial infarction. Circulation. 2019;139:137-139
Sandhu RK, Ezekowitz JA. Is incentivising stroke prevention therapy in atrial fibrillation the key?(Editorial) Heart. 2019;105:4-5 Saw J, Starovoytov A, Humphries K, Sheth T, So D, Minhas K, Brass N, Lavoie A, Bishop H, Lavi S, Pearce C, Renner S, Madan M, Welsh RC, Lutchmedial S, Vijayaraghavan R, Aymong E, Har B, Ibrahim R, Gornik HL, Ganesh S, Buller C, Matteau A, Martucci G, Ko D, Mancini GBJ. Canadian spontaneous coronary artery dissection cohort study: in-hospital and 30-day outcomes. Eur Heart J. 2019 doi: 10.1093/eurheartj/ehz007 Senaratne JM, Norris CM, Youngson E, McClure RS, Nagendran J, Butler CR, Meyer SR, Anderson TJ, van Diepen S. Variables associated with cardiac surgical waitlist mortality from a population-based cohort. Can J Cardiol. 2019;35:61-67
Welsh RC, MacFarlane K, Quraishi AUR; Canadian Cardiovascular Society Percutaneous Coronary Intervention Quality Working Group. Canadian cardiovascular society and Canadian Institute of Health Information Public Reporting of percutaneous coronary intervention quality indicators. Can J Cardiol. 2018;34:1539-1540 Wong GC, Welsford M, Ainsworth C, Abuzeid W, Fordyce CB, Greene J, Huynh T, Lambert L, Le May M, Lutchmedial S, Mehta SR, Natarajan M, Norris CM, Overgaard CB, Perry Arnesen M, Quraishi A, Tanguay JF, Traboulsi M, van Diepen S, Welsh R, Wood DA, Cantor WJ; members of the Secondary Panel. 2019 Canadian Cardiovascular Society/Canadian Association of Interventional Cardiology Guidelines on the acute management of ST-elevation myocardial infarction: Focused update on regionalization and reperfusion. Can J Cardiol. 2019;35:107-132
Shavadia JS, Vo MN, Bainey KR. Challenges with severe coronary artery calcification in percutaneous coronary intervention: A narrative review of therapeutic options. Can J Cardiol. 2018;34:1564-1572
Wood DA, Lauck SB, Cairns JA, Humphries KH, Cook R, Welsh R, Leipsic J, Genereux P, Moss R, Jue J, Blanke P, Cheung A, Ye J, Dvir D, Umedaly H, Klein R, Rondi K, Poulter R, Stub D, Barbanti M, Fahmy P, Htun N, Murdoch D, Prakash R, Barker M, Nickel K, Thakkar J, Sathananthan J, Tyrell B, Al-Qoofi F, Velianou JL, Natarajan MK, Wijeysundera HC, Radhakrishnan S, Horlick E, Osten M, Buller C, Peterson M, Asgar A, Palisaitis D, Masson J-B, Kodali S, Nazif T, Thourani V, Babaliaros VC, Cohen DJ, Park JE, Leon MB, Webb JG. The Vancouver 3M (Multidisciplinary, Multimodality, But Minimalist) clinical pathway facilitates safe next-day discharge home at low-, medium-, and high-volume transfemoral transcatheter aortic valve replacement centers: The 3M TAVR Study. JACC Cardiovasc Interv. 2019;12:459-469
Stewart RAH, Held C, Krug-Gourley S, Waterworth D, Stebbins A, Chiswell K, Hagstrom E, Armstrong PW, Wallentin L, White H. Cardiovascular and lifestyle risk factors and cognitive function in patients with stable coronary heart disease. J Am Heart Assoc. 2019;8:e010641
Yousefian P, Shin S, Mousavi AS, Kim CS, Finegan B, McMurtry MS, Mukkamala R, Jang DG, Kwon U, Kim YH, Hahn JO. Physiological Association between Limb Ballistocardiogram and Arterial Blood Pressure Waveforms: A Mathematical Model-Based Analysis. Sci Rep. 2019;9:5146. doi: 10.1038/s41598-019-41537-y
Shavadia JS, Southern DA, James MT, Welsh RC, Bainey KR. Kidney function modifies the selection of treatment strategies and long-term survival in stable ischaemic heart disease: Insights from the Alberta Provincial Project for Outcomes Assessment in Coronary Heart Disease (APPROACH) registry. Eur Heart J Qual Care Clin Outcomes. 2018;4:274-282
Ungar L, Clare RM, Rodriguez F, Kolls BJ, Armstrong PW, Aylward P, Held C, Moliterno DJ, Strony J, Van de Werf F, Wallentin L, White HD, Tricoci P, Harrington RA, Mahaffey KW, Melloni C. Stroke outcomes with vorapaxar versus placebo in patients with acute coronary syndromes: Insights from the TRACER trial. J Am Heart Assoc. 2018;7:e009609
About the Chronicle 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.
CVC gratefully acknowledges our sponsors and the funding support provided by: American Regent Bayer Health Care Pharmaceutials Inc. Canadian Institute of Health Research CSL Behring LLC
Chronicle Editorial Board
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.thecvc.ca
Leuven Research and Development Merck & Co., Inc. University Hospital Foundation
Paul W. Armstrong Kalli Belseck Kate Dawson Justin Ezekowitz Lyndsey Garritty
@CVC_UAlberta
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Shaun Goodman Courtney Gubbels Karin Kushniruk Jodi Parrotta
Ellen Pyear Kris Reay Melisa Spaling Tracy Temple