NCT00362388

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2006

Typical duration for phase_3

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

January 27, 2010

Status Verified

November 1, 2008

Enrollment Period

2.8 years

First QC Date

August 8, 2006

Last Update Submit

January 26, 2010

Conditions

Ischemic Heart DiseaseCoronary Artery Disease

Keywords

Coronary artery diseaseIschemic heart diseaseAngiogenesisCellsCardiac surgery

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • 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.

Interventions

Intramyocardial injection of autologous bone marrow cellsPROCEDURE

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Irmandade da Santa Casa de Misericórdia

Curitiba, Paraná, 80010-030, Brazil

Location

Clínica Cardiologyca C. Constantini

Curitiba, Paraná, 80320-320, Brazil

Location

Instituto do Coração de Pernambuco do Real Hospital Português de Beneficência

Recife, Pernambuco, 52010-040, Brazil

Location

Instituto Nacional de Cardiologia Laranjeiras (INCL)

Rio de Janeiro, Rio de Janeiro, 22240-002, Brazil

Location

Hospital Pró-Cardíaco

Rio de Janeiro, Rio de Janeiro, 22280-000, Brazil

Location

Heart Institute (InCor), Hospital das Clínicas, University of São Paulo Medical School

São Paulo, São Paulo, 05403-900, Brazil

Location

Related Links

MeSH Terms

Conditions

Myocardial IschemiaCoronary Artery Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Sergio A. de Oliveira, MD, PhD

    Heart Institute (InCor), Hospital das Clinicas, University of São Paulo Medical School

    PRINCIPAL INVESTIGATOR

  • Jose Eduardo Krieger, MD, PhD

    Heart Institute (InCor), Hospital das Clinicas, University of São Paulo Medical School

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 8, 2006

First Posted

August 10, 2006

Study Start

January 1, 2006

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

January 27, 2010

Record last verified: 2008-11

Locations

BR(6)