A randomized study to assess the safety, feasibility and effectiveness of direct intramyocardial percutaneous delivery of autologous bone marrow-derived total mononuclear cells or selected CD34+ cells in patients with refractory angina pectoris.
Primary Endpoint: Incidence of major adverse cardiac events (MACE) at 30 days. MACE is defined as a combined endpoint of death, acute MI (Q-wave and non-Q wave), revascularization procedures (percutaneous or surgical), and peri-procedural complications (that is, left ventricular perforation with hemodynamic consequences requiring pericardiocentesis, and stroke). Incidence of MACE at 3, 6 and 12 months Secondary Endpoints: * Change in Canadian Cardiovascular Society (CCS) angina classification score from baseline to 12 months * Changes in the quality of life, as assessed according to the Seattle Angina Questionnaire * Change in exercise duration and exercise tolerance using standardized treadmill exercise testing from baseline, to 6 months and to 12 months * Cumulative number of hospitalizations for coronary ischemia and congestive heart failure at 12 months following treatment. * SPECT-chances in global and regional radionuclide perfusion at rest, peak stress, and redistribution for baseline to 1, 6 and 12 months * Change in angiographic collateral score at 6 months * Change in global and regional myocardial contractility (assessed by echocardiography) at baseline, 6 and 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
13
Direct intramyocardial percutaneous delivery of autologous bone marrow-derived total mononuclear cells or selected CD34+ cells
IRCCS S. Raffaele
Milan, Italy
Incidence of major adverse cardiac events (MACE), defined as a combined endpoint of death, acute MI (Q-wave and non-Q wave), revascularization procedures and peri-procedural complications.
Time frame: 1, 6, 12 months
Change in Canadian Cardiovascular Society (CCS) angina classification score
Time frame: 12 months
Changes in the quality of life, as assessed according to the Seattle Angina Questionnaire
Time frame: 1,3,6,12 months and every year for 8 years
Change in exercise duration and exercise tolerance using standardized treadmill exercise testing
Time frame: 6,12 months
Cumulative number of hospitalizations for coronary ischemia and congestive heart failure
Time frame: 12 months
SPECT-chances in global and regional radionuclide perfusion at rest, peak stress, and redistribution
Time frame: 1, 6, 12 months
Change in angiographic collateral score
Time frame: 6 months
Change in global and regional myocardial contractility (assessed by echocardiography)
Time frame: 6, 12 months
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