open to eligible people ages 21 years and up
The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease. This is a multicenter randomized controlled trial with a target enrollment of ~5000 patients with at least moderate ischemia on stress imaging. Patients will be assigned at random to a routine invasive strategy (INV) with cardiac catheterization (cath) followed by revascularization plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cath and revascularization reserved for those who fail OMT. SPECIFIC AIMS A. Primary Aim The primary aim of the ISCHEMIA trial is to determine whether an initial invasive strategy of cardiac catheterization followed by optimal revascularization, if feasible, in addition to OMT, will reduce the primary composite endpoint of cardiovascular death or nonfatal myocardial infarction in participants with SIHD and at least moderate ischemia over an average follow-up of approximately 4 years compared with an initial conservative strategy of OMT alone with catheterization reserved for failure of OMT. The primary endpoint is time to centrally adjudicated cardiovascular death or nonfatal myocardial infarction. B. Secondary Aims Major: To compare angina-related quality of life between groups. Other secondary aims include: a) comparing the incidence of all-cause death; the components of the primary endpoint; the composite endpoint of cardiovascular death, myocardial infarction, or hospitalization for unstable angina, resuscitated cardiac arrest, or heart failure; stroke; and stroke combined with cardiovascular death, myocardial infarction, or hospitalization for unstable angina, resuscitated cardiac arrest, or heart failure between randomized groups; and b) comparing health resource utilization, costs, and cost-effectiveness between groups. Condition: Coronary Disease Procedure: Coronary CT Angiogram Procedure: Cardiac catheterization Phase: Phase III Condition: Cardiovascular Diseases Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions Phase: Phase III Condition: Heart Diseases Procedure: Coronary Artery Bypass Surgery Phase: Phase III
Fresno, California and other locations
Sorry, accepting new patients by invitation only
South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high rates of cardiovascular disease that is not explained by traditional cardiovascular risk factors. Though South Asians represent over one-quarter of the world's population, there are no longitudinal studies in this high-risk ethnic group. The investigators aim to establish a longitudinal study of South Asians at two United States centers to identify risk factors linked to subclinical atherosclerosis and incident cardiovascular disease. The purpose of this study is to understand the causes of heart disease and stroke in South Asians and compare these causes to those in other United States ethnic groups.
San Francisco, California and other locations