Cell Therapy in Chronic Ischemic Heart Disease
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Intramyocardial Injection of Autologous Bone-Marrow Cells in Patients With Severe, Chronic Ischemic Heart Disease Undergoing Coronary Bypass Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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 symptomatic despite maximally tolerated medical therapy. Others are considered non-optimal candidates for a complete myocardial revascularization procedure due to the extension and diffuseness of the disease.
Cell therapy with autologous bone marrow-derived cells (BMC) is a novel therapeutic strategy being tested for many cardiovascular diseases, including heart failure, acute myocardial infarction, chronic ischemic heart disease.
The primary objective of this study is to assess the efficacy of intramyocardial injection of autologous BMC on the myocardial perfusion and left ventricular function as an adjunctive therapy (compared to placebo) in patients undergoing coronary artery bypass surgery (CABG).
The secondary objective of this study is to assess the effect of intramyocardial injection of autologous BMC on functional class (angina/heart failure), functional capacity, global and cardiovascular mortality, and quality of life in patients undergoing coronary artery bypass surgery (CABG).
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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PE
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Recife, PE, Brazil, 52010-040
- Instituto do Coração de Pernambuco do Real Hospital Português de Beneficência
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PR
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Curitiba, PR, Brazil, 80010-030
- Irmandade da Santa Casa de Misericórdia
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Curitiba, PR, Brazil, 80320-320
- Clínica Cardiologyca C. Constantini
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RJ
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Rio de Janeiro, RJ, Brazil, 22240-002
- Instituto Nacional de Cardiologia Laranjeiras (INCL)
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Rio de Janeiro, RJ, Brazil, 22280-000
- Hospital Pro-Cardiaco
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SP
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São Paulo, SP, Brazil, 05403-900
- Heart Institute (InCor), Hospital das Clínicas, University of São Paulo Medical School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Reduction in the ischemic score (global/regional) at 12 months; increase in left ventricle ejection fraction (LVEF) at 12 months.
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Secondary Outcome Measures
Outcome Measure |
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All-cause and cardiovascular mortality during the first year; increase in VO2max, increase in quality of life, reduction in angina/heart failure functional class at 12 months; percentage of patients with a 5% increase in LVEF at 6 and 12 months.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sergio A. de Oliveira, MD, PhD, Heart Institute (InCor), Hospital das Clínicas, University of São Paulo Medical School
- Study Director: Jose Eduardo Krieger, MD, PhD, Heart Institute (InCor), Hospital das Clínicas, University of São Paulo Medical School
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMRTCC-ISQ
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