Cell Therapy in Chronic Ischemic Heart Disease - Full Text View

Sponsors and Collaborators:	Ministery of Health, Brazil Ministry of Science and Technology
Information provided by:	Ministery of Health, Brazil
ClinicalTrials.gov Identifier:	NCT00362388

Purpose

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 patients from symptoms like angina and/or shortness of breath.

Condition	Intervention	Phase
Ischemic Heart Disease Coronary Artery Disease	Procedure: Intramyocardial injection of autologous bone marrow cells	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Heart Diseases Surgery

U.S. FDA Resources

Further study details as provided by Ministery of Health, Brazil:

Primary Outcome Measures:

Reduction in the ischemic score (global/regional) at 12 months; increase in left ventricle ejection fraction (LVEF) at 12 months.

Secondary Outcome Measures:

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.

Estimated Enrollment:	300
Study Start Date:	January 2006
Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

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).

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362388

Locations

Brazil, PE
Instituto do Coração de Pernambuco do Real Hospital Português de Beneficência
Recife, PE, Brazil, 52010-040
Brazil, PR
Irmandade da Santa Casa de Misericórdia
Curitiba, PR, Brazil, 80010-030
Clínica Cardiologyca C. Constantini
Curitiba, PR, Brazil, 80320-320
Brazil, RJ
Instituto Nacional de Cardiologia Laranjeiras (INCL)
Rio de Janeiro, RJ, Brazil, 22240-002
Hospital Pró-Cardíaco
Rio de Janeiro, RJ, Brazil, 22280-000
Brazil, SP
Heart Institute (InCor), Hospital das Clínicas, University of São Paulo Medical School
São Paulo, SP, Brazil, 05403-900

Sponsors and Collaborators

Ministery of Health, Brazil

Ministry of Science and Technology

Investigators

Principal Investigator:	Sergio A. de Oliveira, MD, PhD	Heart Institute (InCor), Hospital das Clinicas, University of São Paulo Medical School
Study Director:	Jose Eduardo Krieger, MD, PhD	Heart Institute (InCor), Hospital das Clinicas, University of São Paulo Medical School

More Information

Additional Information:

A brief description of the protocol (in Portuguese). This link exits the ClinicalTrials.gov site

Link to the Heart Institute (InCor), in São Paulo, Brazil (in Portuguese). This link exits the ClinicalTrials.gov site

Link to the Instituto Nacional de Cardiologia Laranjeiras (INCL), in Rio de Janeiro, Brazil (In Portuguese). This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	EMRTCC-ISQ
Study First Received:	August 8, 2006
Last Updated:	November 19, 2008
ClinicalTrials.gov Identifier:	NCT00362388 History of Changes
Health Authority:	Brazil: National Committee of Ethics in Research; Brazil: Ministry of Health

Keywords provided by Ministery of Health, Brazil:

Coronary artery disease
Ischemic heart disease
Angiogenesis
Cells
Cardiac surgery

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Pathologic Processes
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

ClinicalTrials.gov processed this record on September 02, 2009