【實用健康app】ISCHEMIA Trial|最夯免費app-綠色工廠好玩App

ISCHEMIA is an NHLBI-funded international randomized controlled trial comparing the effectiveness of two initial management strategies in 8,000 patients with moderate or severe ischemia on stress imaging: an invasive strategy with cardiac catheterization and optimal revascularization plus OMT versus a conservative strategy with OMT alone and cath reserved for patients who fail medical therapy. The study hypothesis is that an invasive strategy will reduce the incidence of cardiovascular death or nonfatal MI compared with a conservative strategy. Patients who qualify on the basis of ischemia and have normal renal function will undergo blinded coronary CT angiography (CCTA) to exclude left main disease and to confirm the presence of obstructive coronary artery disease prior to randomization. Eligible patients are then randomized to the invasive or conservative strategy.

Accrual is projected to last 4 years with a minimum 1.5 years and maximum 6 years of follow-up. Patients randomized to the invasive group will undergo optimal revascularization—PCI or CABG—as recommended by the local interventional cardiologist and cardiovascular surgeon based on protocol recommendations. Patients randomized to the conservative strategy will be permitted to undergo invasive management as needed for refractory angina or acute coronary syndrome. The protocol is designed to minimize unnecessary cath in patients randomized to the conservative strategy. The primary outcome measure is time to cardiovascular death or nonfatal MI. Secondary outcome measures will include quality of life, cost-effectiveness, and cardiovascular hospitalizations. Enrollment began in late 2012.