By Pass Surgery With Stem Cell Therapy in Chronic Ischemic Cardiopathy
Recruitment status was Recruiting
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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. |
- Evolution of left ventricular volumes and contractility Evolution of left ventricular volumes and contractility
- Functional status
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | May 2011 (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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Patrick Lacarin | 04.73.751.195 | placarin@chu-clermontferrand.fr |
| France | |
| Departements of CardiacSurgery, Cardiology and Radiology | Recruiting |
| Clermont-Ferrand, France | |
| Contact: Janusz Lipiecki jlipiecki@chu-clermontferrand.fr | |
| Principal Investigator: | Janusz Lipiecki, Dr | University Hospital, Clermont-Ferrand |
More Information
No publications provided
| Responsible Party: | Dr Lipiecki, CHU Clermont-Ferrand |
| ClinicalTrials.gov Identifier: | NCT00690209 History of Changes |
| Other Study ID Numbers: | CHU-0034 |
| Study First Received: | May 30, 2008 |
| Last Updated: | January 18, 2011 |
| 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 June 17, 2013