Cardiovascular Diseases Clinical Trials in Canada

A multi-site, multi-modality prospective observational clinical outcomes study focussed on the development of phenotype-dirven risk prediction modelling in patients with known or suspected cardiovascular disease. Read Less

Women with breast cancer treated using anthracyclines and/or trastuzumab are at an increased risk of cardiovascular disease (CVD) following treatment completion. Exercise is known to reduce CVD risk in healthy and several clinical populations, but, whether existing cardiac rehabilitation programs can be leveraged to reduce CVD risk in breast cancer survivors is unknown. This study aims to: i) understand the feasibility of virtual versus in-person cardiac rehabilitation in breast cancer survivors; and ii) compare the effect of virtual versus in-person cardiac rehabilitation on cardiovascular function and injury biomarkers, physical fitness, and psychosocial health. 50 breast cancer survivors with increased CVD risk will be recruited and randomized to either the in-person or virtual arm of the cardiac rehabilitation program at Women's College Hospital (WCH). Data will be collected at baseline, following program completion, and 6-months after program completion. The primary outcomes are measures of study feasibility. Other clinically relevant outcomes to be collected include: i) imaging and blood-based biomarkers of cardiovascular function; ii) physical fitness; iii) objective and self-reported physical activity levels; and iv) self-reported measures of psychosocial wellbeing. These findings will be used to inform the design of a larger-scale cardio-oncology trial and will facilitate development of more comprehensive CVD risk management strategies for breast cancer survivors at WCH. Read Less

To examine the impact of health determinants at the individual (e.g. health related behaviors) and societal level (e.g. environmental factors, health related policy, quality of health systems) on health outcomes (e.g. death, non-communicable disease development) across a range of socioeconomic and health resource settings. Additional components of this study will examine genetic factors for non-communicable diseases. This will be examined both through a cross sectional component, and prospectively (cohort component). Read Less

Cardiac implantable electronic devices (CIED) are established treatments for a variety of cardiac arrhythmias. Women with CIED have lower fitness and lower quality of life compared to men with CIED. Moderate-intensity continuous training (MICT) is the most prescribed exercise for women. However, high-intensity interval training (HIIT) has been shown to improve fitness, anxiety levels, quality of life, and other health indicators over MICT in men with CIED. There is a need to quantitatively evaluate the feasibility and effects of a virtual HIIT vs. virtual MICT program on the physical, quality of life, and mental health of women with CIED. Furthermore, a qualitative approach is also necessary to understand patients' experiences, barriers, and facilitators of a virtual exercise intervention. This mixed-methods pilot randomized controlled trial will assess the feasibility of a 12-week virtual HIIT and MICT program in women with CIED. Read Less

Traditional randomized clinical trials (RCTs) have provided extremely valuable information on medical therapies and procedures that have changed the way heart diseases are treated. However, despite these contributions, traditional RCTs are costly, the findings may not be applicable to patients unlike those in the study, and the use of trial findings may be infrequent. These limitations may be addressed by incorporating 'big data' in RCTs, which is the emerging field using electronic information that is routinely collected in various large administrative health databases. The Community Heart Outcomes Improvement and Cholesterol Education Study (CHOICES) will test the potential of using 'big data' in a 'real-world' clinical trial to measure outcomes using routinely collected health information. CHOICES aims to increase the use of cholesterol-lowering statin drugs to prevent heart attack and stroke in high-risk health regions across Ontario using a 'toolbox' of interventions. The 'toolbox' of interventions are informational strategies targeted for both patients and family physicians to help improve cholesterol management and contribute to shared decision making for heart healthy goals. Read Less

This is an international prospective, multicentre, unblinded, randomised-controlled trial. The primary aim is to assess a targeted screening strategy to detect undiagnosed heart failure in high-risk patients. Read Less

SEMA-VR is a prospective, randomized, 6-month long, open-label study of semaglutide. Approximately 100 participants with type 2 diabetes and/or obesity will be randomized (1:1) to receive semaglutide at escalating doses (up to 1.0 mg/week) or usual care without semaglutide for 6 months. The goal of this trial is to understand how semaglutide exerts cardio-protective effects in people with type 2 diabetes and/or obesity. The main question it aims to answer is: • Does semaglutide treatment preserve or increase the number of vessel-repairing cells circulating in the blood? Participants will: * Be allocated to receive either semaglutide or usual care for 6 months * Provide a blood sample at the baseline visit and another blood sample at the 6-month visit Researchers will compare participants receiving semaglutide to those receiving usual care for any differences in the 6-month change in the number of vessel-repairing cells in the blood. Read Less

The purpose of this study is to compare the effectiveness of a 4-week lower extremity telerehabilitation protocol with aims to improve lower extremity function to a 4-week attention-controlled education program on lower extremity clinical outcomes, quality of life, and healthcare resources utilization among community dwelling adults with stroke across Canada. Read Less