Cell Therapy in Chronic Ischemic Heart Disease

This study has been terminated.
(low enrollling)
Sponsor:
Collaborator:
Ministry of Science and Technology
Information provided by:
Ministry of Health, Brazil
ClinicalTrials.gov Identifier:
NCT00362388
First received: August 8, 2006
Last updated: January 26, 2010
Last verified: November 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:


Further study details as provided by Ministry 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Brazil
Instituto do Coração de Pernambuco do Real Hospital Português de Beneficência
Recife, PE, Brazil, 52010-040
Irmandade da Santa Casa de Misericórdia
Curitiba, PR, Brazil, 80010-030
Clínica Cardiologyca C. Constantini
Curitiba, PR, Brazil, 80320-320
Instituto Nacional de Cardiologia Laranjeiras (INCL)
Rio de Janeiro, RJ, Brazil, 22240-002
Hospital Pró-Cardíaco
Rio de Janeiro, RJ, Brazil, 22280-000
Heart Institute (InCor), Hospital das Clínicas, University of São Paulo Medical School
São Paulo, SP, Brazil, 05403-900
Sponsors and Collaborators
Ministry 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:
No publications provided

ClinicalTrials.gov Identifier: NCT00362388     History of Changes
Other Study ID Numbers: EMRTCC-ISQ
Study First Received: August 8, 2006
Last Updated: January 26, 2010
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: Ministry of Health

Keywords provided by Ministry of Health, Brazil:
Coronary artery disease
Ischemic heart disease
Angiogenesis
Cells
Cardiac surgery

Additional relevant MeSH terms:
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 29, 2014