Status:
TERMINATED
Cell Therapy in Chronic Ischemic Heart Disease
Lead Sponsor:
Ministry of Health, Brazil
Collaborating Sponsors:
Ministry of Science and Technology
Conditions:
Ischemic Heart Disease
Coronary Artery Disease
Eligibility:
All Genders
30-75 years
Phase:
PHASE3
Brief Summary
This study was designed to test the hypothesis that direct injection of bone-marrow cells in the heart may increase the number of blood vessels, ameliorating the heart's performance, and relieving pat...
Detailed Description
Severe ischemic heart disease (IHD) remains a clinical challenge; many patients with IHD have undergone myocardial revascularization procedures (either percutaneous or surgical) but still remain sympt...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00362388
Start Date
January 1 2006
End Date
November 1 2008
Last Update
January 27 2010
Active Locations (6)
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1
Irmandade da Santa Casa de Misericórdia
Curitiba, Paraná, Brazil, 80010-030
2
Clínica Cardiologyca C. Constantini
Curitiba, Paraná, Brazil, 80320-320
3
Instituto do Coração de Pernambuco do Real Hospital Português de Beneficência
Recife, Pernambuco, Brazil, 52010-040
4
Instituto Nacional de Cardiologia Laranjeiras (INCL)
Rio de Janeiro, Rio de Janeiro, Brazil, 22240-002