Clinical trials

In cardiac surgery, the presence of pulmonary hypertension (PH) is a prognostic factor associated with increased mortality and morbidity. In this context, one of the main causes of PH is related to reperfusion ischemia during weaning from extracorporeal circulation (CPB). One of the consequences of PH is right ventricular dysfunction. During weaning from CPB, the development of a right ventricular dysfunction is associated with increased requirements for vasopressor and inotropic agents, duration of mechanical ventilation, prolonged intensive care and hospital stay, and increased mortality compared with patients with left ventricular (LV) dysfunction. The management of patients with PH with or without right ventricular (RV) dysfunction relies on several strategies such as the administration of intravenous and inhaled agents, or mechanical ventricular support. Among those agents, the administration of inotropes or pulmonary vasodilators such as epoprostenol, milrinone and nitric oxide are among the most widely used treatments recommended by the Canadian Cardiovascular Society. At the Montreal Heart Institute, inhaled epoprostenol and milrinone are routinely administered to patients with PH or LV dysfunction in the perioperative setting. Despite the frequent use of inhaled epoprostenol and milrinone, Health Canada has not yet approved the use of these molecules. The primary objective of this multicenter, double-blind, randomized clinical trial is to evaluate the clinical efficacy of the combined administration of inhaled epoprostenol and milrinone in a cardiac surgery setting. This trial will compare the clinical outcome of 71 patients who will receive inhaled epoprostenol and milrinone before the start of bypass surgery to 71 patients who will receive a placebo before the start of the CPB. The primary clinical outcome is the proportion of patients with an "unsuccessful" CPB weaning defined by the use of an inotrope +/- vasopressor agent or the use of mechanical circulatory support or a return to bypass grafting for hemodynamic reasons. This clinical trial will evaluate the clinical efficacy of the combination of inhaled agents in a cardiac surgery setting. Therefore, if the results of this study are positive, the combination of inhaled epoprostenol and milrinone will optimize the management of patients with pulmonary hypertension with or without a right ventricular dysfunction.

In patients with subclinical coronary artery disease, the ASCAD-P study aims to assess the feasibility of a larger phase 3 pragmatic randomized controlled trial comparing prescription versus no prescription of low-dose aspirin in routine clinical practice.

Insulin resistance and hyperglycemia predispose individuals with type 2 diabetes mellitus (T2DM) to endothelial dysfunction and a greater risk of cardiovascular diseases (CVD). Increased CVD risk in individuals with T2DM persists despite optimal pharmacological therapy, highlighting the need to identify complementary lifestyle interventions that improve cardiometabolic functions in this population. Evidence from animal models suggests that heat exposure improves metabolic functions. Notably, weekly heat exposure for 16 weeks blunts hyperinsulinemia and hyperglycemia induced by a high fat diet in mice. In parallel, studies in humans have shown that heat exposure improves vascular endothelial function. Based on such findings, it has been suggested that heat therapy may represent an effective lifestyle intervention to improve cardiometabolic functions. However, only 1 study has examined the impact of a heat therapy intervention on individuals with T2DM, demonstrating that 6 weeks of heat exposure reduces fasting plasma glucose and hemoglobin A1C. No study has considered potential vascular benefits of heat therapy in individuals with T2DM. This project will investigate cardiometabolic responses to repeated heat exposure in men and women with T2DM. We will test the hypothesis that 12 weeks of heat therapy improves postprandial fatty acid handling, insulin sensitivity and endothelial function in individuals with T2DM.

To evaluate the efficacy and safety of colchicine and non-enteric coated aspirin, combined or alone, to improve cardiovascular outcomes in high-risk patients with type 2 diabetes.

In patients with a myocardial infarction (MI) treated medically alone, the objective of the PANTHEON trial is to evaluate if ticagrelor monotherapy reduces bleeding events, without an increase in patient-oriented ischemic events, compared with standard dual antiplatelet therapy (DAPT) with aspirin and ticagrelor for 12 months.

Among patients with acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI) and stent implantation, 17.5% are both at high bleeding risk (HBR) and have undergone complex PCI, which also places them at high thrombotic risk. In this population, several dual antiplatelet therapy (DAPT) strategies may be considered: (1) de-escalation of DAPT intensity after 1 to 3 months (switch from ticagrelor/prasugrel to clopidogrel), (2) shortening DAPT duration to 1 to 3 months followed by antiplatelet monotherapy, (3) 12-month clopidogrel-based DAPT, and (4) 12-month ticagrelor/prasugrel-based DAPT. Selecting the most appropriate DAPT strategy in this dual-risk context is complex, and clinical trial evidence is limited for this specific subgroup. In the absence of clear guideline recommendations to support decision-making for patients facing both elevated bleeding and thrombotic risks, structured shared decision-making support is needed. In this context, within research project 2025-3499 conducted with pharmacy residents, we developed a patient decision aid (PDA) designed to support shared decision-making by helping patients understand their risks, available options, and potential consequences, so they can express their preferences regarding antiplatelet therapy. The PDA aims to facilitate shared decisions by improving patients' understanding of benefits and harms and aligning choices with patient values. A preliminary version of the tool has already undergone alpha testing with a small group of internal users (physicians, pharmacists, and patient partners). The next step is beta testing, that is, real-world testing with the target population and clinicians to evaluate usability and acceptability in routine practice.

Because treatment decisions are usually based on a single measurement of the lipid panel at the time of an admission for an MI, the overarching objective of this project is to evaluate whether the measurement of LDL, non-HDL, and apoB values are reliable through all the duration of the hospitalization. It will be a single-center, prospective, observational study will be conducted, including consecutive patients hospitalized for myocardial infarction at the Montreal Heart Institute. Every patient at the Cardiac Care Unit will undergo non-fasting lipid panel testing at day 0 of their admission for Myocardial Infarction during the study period. Patients who consent to participate will have a 2nd non-fasting lipid panel drawn at day 2 of their admission. Thereafter, the levels of the different lipid values from the panel will be compared between day 0, day 2, and 4-6 weeks after discharge.

This phase 2 study will include patients suffering from type 2 diabetes mellitus and will first study their response to enteric coated aspirin at a dose of 80 mg per day for a 7-day period. Participants with an incomplete platelet inhibition after exposure to EC aspirin at doses of 80 mg once daily will be randomized to a random order of 3 different ASA regimens: EC ASA 162 mg once daily, EC ASA 81 mg twice daily and chewable ASA 40 mg twice daily. The aims are to determine the feasibility of a larger scale trial, and to determine the regimen associated with the lowest proportion of non-responders after randomization. Platelet function will be assessed at baseline and at day 7 of each arms of the study.

The NEPTUNE triple-blind, active-placebo, adaptive, pragmatic, randomized trial aims to evaluate the effectiveness of a new intra-venous hydration strategy guided by left ventricular end-diastolic pressure (LVEDP), amount of contrast used, and baseline renal function, to prevent contrast-induced acute kidney injury (CI-AKI) and patient-oriented clinical endpoints in all-comer patients undergoing coronary angiogram and/or percutaneous coronary intervention (PCI).

The objective of this project is to assess the effects of combined physical exercise and cognitive training interventions on cognitive and brain health in patients with heart failure (HF). Also, the role of sex on the effects of the interventions will be assessed.

This non-interventional study aims to use artificial intelligence to improve the prediction of transcatheter heart valve interventions and optimize patient outcomes. It is based on the analysis of retrospective data from various specialized centers worldwide.

The DAISEA-ECG project aims to improve the diagnosis of heart diseases in primary care through the DeepECG platform, which combines ECG-AI and ECHONeXT algorithms. This study uses a stepped wedge design, where each Family Medicine Group acts as its own control. The FMGs will gradually transition from the control period (without AI recommendations) to the intervention period (with AI recommendations activated) in a randomized sequence. The primary objective is to compare the sensitivity of family physicians in detecting cardiac pathologies, with and without the assistance of the DeepECG platform. Sensitivity is defined as the proportion of patients correctly referred to cardiology or for transthoracic echocardiography (TTE) among those who indeed required cardiovascular evaluation, as confirmed by an independent adjudication committee.

The goal of this study is to learn if an exercise-based prehabilitation program can help people who are waiting for heart surgery and are at higher risk of complications recover better. The main questions it aims to answer are: Can a home-based prehabilitation program prescribed by a physiotherapist be done safely and realistically before heart surgery? Participants will: Take part in a personalized exercise program for a 8 to 16 weeks before surgery Do breathing muscle training at home Meet with a physiotherapist once a week, either in person or by video call Be assessed before and after the program Researchers will compare the postoperative results with those of patients who received usual care only.

The main goal of CaNICM is to create a central database that includes a biobank and an imaging data repository for patients with non-ischemic cardiomyopathy (NICM), as well as for at-risk family members. This includes people who carry rare genetic variants linked to NICM but do not show symptoms, and first-degree relatives. The specific goals of this database and biobank are to: Enhance investigators' ability to predict the risk of heart rhythm disorders in patients with NICM. Optimize the timing and approach for screening family members who may carry the disease - determining who to test, when, and how. Find the best ways to treat family members early to prevent or slow the disease. Future Phase - Phase 2 Goal: 4\. Prospectively evaluate how well this risk prediction model works in real-life clinical settings, and compare it to the current approach, which is often based on a single risk factor.

The primary hypothesis of the proposed study is that an electrophysiology-based algorithmic approach is superior to standard clinical follow-up with 30-day monitoring in reducing the combined endpoint of syncope, hospitalization, and death in patients in patients with new of left bundle branch block following transcatheter aortic valve implantation (TAVI).

The purpose of this pilot study is to obtain a preliminary assessment of the effect of VK supplementation on cognitive performance and vascular function in adults with stable Coronary Heart Disease (CHD)

To demonstrate that a virtual Heart Failure Clinic (HFC) based on patient self-management using Pulmonary Artery Pressure (PAP) monitoring is superior to usual care of HFC, leads to decreased: hospital admissions for heart failure (HF), emergency department consultation and/or unplanned intravenous heart failure therapy and cardiovascular death, compared to a regular HFC, has low device-related complications and is cost-effective, in New York Heart Association (NYHA) class III and II (requiring diuretics) patients.

The proposed study is a multicentric prospective observational cohort study of patients with suspected NVE. The study population includes those with Possible IE according to the modified Duke criteria and investigated at one of the 6 participating sites which include 2 cardiac centers, the MHI and the IUCPQ, as well as 4 tertiary care centers, the Jewish General Hospital , the McGill University Health Centre and the CHUS.