By Pass Surgery With Stem Cell Therapy in Chronic Ischemic Cardiopathy
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.
Ischemic Heart Disease
Procedure: Autologous bone marrow derived stem cells myocardial transplantation
|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.|
- Evolution of left ventricular volumes and contractility Evolution of left ventricular volumes and contractility
- Functional status
|Study Start Date:||May 2008|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00690209
|Departements of CardiacSurgery, Cardiology and Radiology|
|Principal Investigator:||Janusz Lipiecki, Dr||University Hospital, Clermont-Ferrand|