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Cell Therapy in Chronic Ischemic Heart Disease

Primary Purpose

Ischemic Heart Disease, Coronary Artery Disease

Status
Terminated
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Intramyocardial injection of autologous bone marrow cells
Sponsored by
Ministry of Health, Brazil
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring Coronary artery disease, Ischemic heart disease, Angiogenesis, Cells, Cardiac surgery

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Instituto do Coração de Pernambuco do Real Hospital Português de Beneficência
  • Irmandade da Santa Casa de Misericórdia
  • Clínica Cardiologyca C. Constantini
  • Instituto Nacional de Cardiologia Laranjeiras (INCL)
  • Hospital Pró-Cardíaco
  • Heart Institute (InCor), Hospital das Clínicas, University of São Paulo Medical School

Outcomes

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.

Full Information

First Posted
August 8, 2006
Last Updated
January 26, 2010
Sponsor
Ministry of Health, Brazil
Collaborators
Ministry of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT00362388
Brief Title
Cell Therapy in Chronic Ischemic Heart Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Terminated
Why Stopped
low enrollling
Study Start Date
January 2006 (undefined)
Primary Completion Date
November 2008 (Anticipated)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ministry of Health, Brazil
Collaborators
Ministry of Science and Technology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Coronary Artery Disease
Keywords
Coronary artery disease, Ischemic heart disease, Angiogenesis, Cells, Cardiac surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Intramyocardial injection of autologous bone marrow cells
Primary Outcome Measure Information:
Title
Reduction in the ischemic score (global/regional) at 12 months; increase in left ventricle ejection fraction (LVEF) at 12 months.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio A. de Oliveira, MD, PhD
Organizational Affiliation
Heart Institute (InCor), Hospital das Clinicas, University of São Paulo Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose Eduardo Krieger, MD, PhD
Organizational Affiliation
Heart Institute (InCor), Hospital das Clinicas, University of São Paulo Medical School
Official's Role
Study Director
Facility Information:
Facility Name
Instituto do Coração de Pernambuco do Real Hospital Português de Beneficência
City
Recife
State/Province
PE
ZIP/Postal Code
52010-040
Country
Brazil
Facility Name
Irmandade da Santa Casa de Misericórdia
City
Curitiba
State/Province
PR
ZIP/Postal Code
80010-030
Country
Brazil
Facility Name
Clínica Cardiologyca C. Constantini
City
Curitiba
State/Province
PR
ZIP/Postal Code
80320-320
Country
Brazil
Facility Name
Instituto Nacional de Cardiologia Laranjeiras (INCL)
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22240-002
Country
Brazil
Facility Name
Hospital Pró-Cardíaco
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22280-000
Country
Brazil
Facility Name
Heart Institute (InCor), Hospital das Clínicas, University of São Paulo Medical School
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-900
Country
Brazil

12. IPD Sharing Statement

Links:
URL
http://www.incor.usp.br
Description
Link to the Heart Institute (InCor), in São Paulo, Brazil (in Portuguese).
URL
http://www.incl.rj.saude.gov.br
Description
Link to the Instituto Nacional de Cardiologia Laranjeiras (INCL), in Rio de Janeiro, Brazil (In Portuguese).

Learn more about this trial

Cell Therapy in Chronic Ischemic Heart Disease

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