By Pass Surgery With Stem Cell Therapy in Chronic Ischemic Cardiopathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00690209
First received: May 30, 2008
Last updated: July 4, 2014
Last verified: July 2014
  Purpose

Surgical revascularization has proven its efficacy in term of morbidity and mortality in patients with multivessel coronary disease and poor left ventricular function. Nevertheless, if left ventricle is severely dilated, the improvement of global contractility and reduction of volumes is frequently absent after CABG even if substantial amount of myocardial viability is present. A value of > 140 ml for end systolic volume has been proposed as the cut off for the absence of recovery after revascularization.

Recently, a reduction of cardiac volumes and improvement of regional and global contractility has been demonstrated in patients with advanced ischemic heart disease, severe dilation of left ventricle and poor candidates for revascularization after injection of stem cells in territories with residual viability.


Condition Intervention Phase
Ischemic Heart Disease
Procedure: Autologous bone marrow derived stem cells myocardial transplantation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Efficacy of Surgical Coronary Revascularization Associated With Stem Cells Injection in Patients With Severe Chronic Ischemic Heart Disease With Residual Viability. A Prospective, Controlled Pilot Trial.

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Evolution of left ventricular volumes and contractility Evolution of left ventricular volumes and contractility

Secondary Outcome Measures:
  • Functional status

Enrollment: 12
Study Start Date: May 2008
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Detailed Description:

The screening of patients will be performed after contrast coronar ventriculography realized for diagnostic or prognostic purpose.

Subsequently all patients will be evaluated by cardiac ce-MR and PET imaging for verification of inclusion criteria.

Patients will be allocated in a single blind manner to one of two therapeutic arms: surgical revascularization alone or surgical revascularization associated with autologous bone marrow derived stem cells injection in viable territories.

During the follow up evolution of left ventricular volumes and contractility will be analyzed by ce-MR and PET imaging at 1 year. Additionally patients' functional status will be assessed by metabolic stress tests and quality of life questionnaire at 6 months, 1 year and 2 years.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic ischemic heart disease
  • Left ventricular dilation (end systolic volume >140 ml)
  • Poor global contractile function (ejection fraction <40%)
  • Substantial amount of residual viability (>30% of left ventricle)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00690209

Locations
France
Departements of CardiacSurgery, Cardiology and Radiology
Clermont-Ferrand, France
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Janusz Lipiecki, Dr University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00690209     History of Changes
Other Study ID Numbers: CHU-0034
Study First Received: May 30, 2008
Last Updated: July 4, 2014
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Chronic ischemic cardiomyopathy with residual viability
surgical coronary revascularization
stem cell therapy
Chronic ischemic heart disease
severe impairment of global contractility left ventricular dilation
residual viability

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

ClinicalTrials.gov processed this record on July 20, 2014