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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

May 30, 2008
July 4, 2014
May 2008
January 2013   (final data collection date for primary outcome measure)
Evolution of left ventricular volumes and contractility Evolution of left ventricular volumes and contractility
Same as current
Complete list of historical versions of study NCT00690209 on ClinicalTrials.gov Archive Site
Functional status
Same as current
Not Provided
Not Provided
 
By Pass Surgery With Stem Cell Therapy in Chronic Ischemic Cardiopathy
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.

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Ischemic Heart Disease
Procedure: Autologous bone marrow derived stem cells myocardial transplantation
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
January 2013
January 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00690209
CHU-0034
Not Provided
University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
Not Provided
Principal Investigator: Janusz Lipiecki, Dr University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP