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649 active trials for Coronary (Artery) Disease

Time Restricted Eating and Cardiac Rehabilitation

Time restricted eating (TRE) is a form of intermittent fasting where individuals consume ad libitum energy intake within a set window of time, commonly 8 hours, which induces a fasting window of 16 hours per day (i.e., 16:8 TRE). TRE could be an effective addition to cardiac rehabilitation as it has demonstrated cardiovascular health benefits and potential for synergy when combined with exercise training. This study will be a two site (Toronto Rehabilitation Institute and Toronto Western Hospital), 2-arm, parallel group, randomized feasibility trial of cardiac rehabilitation alone or cardiac rehabilitation plus 16:8 TRE. Men and women who are referred through the standard clinical pathways and eligible for either outpatient cardiac rehabilitation program for coronary artery disease and are willing to accept random assignment and complete the study assessments will be enrolled. Both groups will receive the standard, multi-dimensional cardiac rehabilitation program consisting of physician-directed risk factor management, an individualized exercise prescription, and virtual education. All participants will receive an assessment with a registered dietitian and individualized recommendations for a heart healthy diet. During the consultation with the registered dietitian, the TRE group participants will also be counselled to restrict their eating to between 11 am and 7 pm and consume no calories outside of those hours during the program starting the evening of the consultation. The primary outcome is feasibility measured by daily adherence to the 16-hour fast which will be tracked with two daily text messages for the 16 weeks of the cardiac rehabilitation program. The safety outcomes that will be compared between groups include re-hospitalization, death, angina, and nutritional impact symptoms. Before randomization and after completion of the program the following preliminary efficacy outcomes will be assessed: 1) VO2peak; 2) total body and truncal fat, lean mass; 3) metabolic markers: fasted glucose, insulin, hemoglobin A1c, blood pressure and waist circumference. The investigators hypothesize that cardiac rehabilitation and TRE will be feasible, safe, and provide added cardiovascular health benefits compared to cardiac rehabilitation alone.

Toronto, OntarioStart: October 2021
A Genomic Approach for Clopidogrel in Caribbean Hispanics

Clopidogrel is a prescription medicine used to minimize blood clot formation in patients with cardiovascular disease, particularly those undergoing heart catheterization and stroke. A substantial amount of medical evidence has proven that patients with stroke or heart diseases can benefit from this medicine. However, significant variability in such expected benefits has been found among individuals receiving clopidogrel, with some patients not having the benefit of reduced complications and adverse cardiovascular events. Prior studies have demonstrated a significant association between certain variants on patient's genes (e.g., CYP2C19) and poor response to clopidogrel and, therefore, major adverse cardiovascular events. Variation in other genes and other factors such as platelet activation, weight, diabetes mellitus (a medical condition that produces high blood sugar), concomitant use of other drugs, and smoking status have also been proposed to be related to the same adverse outcomes. In this study, the investigators would like to determine a possible association between these genes and the response to the medication among Caribbean Hispanic cardiovascular patients on clopidogrel. In other populations, it is known that patients with certain genetic variants have lower or magnified responses to this medication when compared to those individuals taking the same dose and not carrying the genetic variations. However, a fundamental gap remains in understanding whether the genomic diversity of Caribbean Hispanics accounts for the observed high inter-individual variability of clinical outcomes to preventive dual antiplatelet therapy (DAPT) with clopidogrel.

CarolinaStart: September 2020
Cytisine Compared to Combination NRT in Relapsed Smokers

Cigarette smoking causes cardiovascular disease (CVD) yet many smokers with CVD are unable to quit despite strong desire to do so. Within 90 days of discharge, about 30% of smokers have returned to daily smoking and almost 60% have relapsed by 1 year. Patients with CVD who resume smoking are more likely to experience new events (e.g. heart attack or stroke) or die. New approaches are required. A new type of cessation product is a plant-based medication called Cytisine. Cytisine is taken orally over 25 days and reduces the pleasurable sensations that smokers get from cigarettes and reduces withdrawal symptoms. The primary research question is whether or not it is feasible to conduct a large-scale trial of the effectiveness of this product compared to conventional nicotine replacement therapy in smokers who have failed to quit using conventional methods. To determine feasibility, a pilot study will be conducted of sixty smokers (30 men, 30 women) with CVD who have been treated for smoking cessation but have relapsed within 90 days of discharge. Participants will complete a baseline assessment and will be randomly assigned to either the combination nicotine replacement therapy group (patch plus lozenge) or cytisine group. Participants will be treated for 25 days and then will return to UOHI so adherence to treatment and smoking status can be assessed. Feasibility of the larger trial will be based on: the recruitment rates; adherence to assigned treatments; dropout rates; and differences in 25-day quit rates between groups.

Ottawa, OntarioStart: January 2022