Cell Therapy in Chronic Ischemic Heart Disease
Ischemic Heart Disease, Coronary Artery Disease
About this trial
This is an interventional treatment trial for Ischemic Heart Disease focused on measuring Coronary artery disease, Ischemic heart disease, Angiogenesis, Cells, Cardiac surgery
Eligibility Criteria
Inclusion Criteria: Diagnosis of chronic, severe, diffuse, multivessel atherosclerotic coronary artery disease (CAD) referred for CABG. Echocardiogram-assessed LVEF between 25 and 55% (Simpson's rule). Angina (or equivalent) functional class II to IV (Canadian Cardiovascular Society) despite maximally tolerated medical therapy. Abnormal myocardial perfusion tests: i. Cardiac scintigraphy ii. Magnetic resonance imaging iii. Dobutamine-atropine stress-echocardiogram Non-candidates for a percutaneous coronary intervention (PCI) due to ANY of the following: i. High risk lesion ii. Extensive lesion iii. Diffuse, small vessel disease Non-candidates for a complete CABG, or candidates for a complete CABG in whom, according to an expert panel, there is a high probability of failure of the grafts due to the extension and severity of the disease, with diffuse, small vessel involvement. To provide a signed, written informed consent, according to the National Guidelines for Clinical Trials. Exclusion Criteria: Severe valve heart disease requiring surgical repair. Serologic diagnostic of Chagas' disease. Symptoms of heart failure, even from an ischemic etiology, in the absence of objectively documented myocardial ischemia. Malignant ventricular arrhythmias (like VT), unless an ICD have been placed. Any acute coronary syndrome in the past 3 months. End-stage renal disease requiring maintenance dialysis. History of neoplasia. Drug or alcohol abuse. Life expectancy below 2 years. Enrollment in any cell therapy trial in the past 2 years.
Sites / Locations
- Instituto do Coração de Pernambuco do Real Hospital Português de Beneficência
- Irmandade da Santa Casa de Misericórdia
- Clínica Cardiologyca C. Constantini
- Instituto Nacional de Cardiologia Laranjeiras (INCL)
- Hospital Pró-Cardíaco
- Heart Institute (InCor), Hospital das Clínicas, University of São Paulo Medical School