Clinical trial NCT00690209: By Pass Surgery With Stem Cell Therapy in Chronic Ischemic Cardiopathy
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ischemic Heart Disease
Keywords: 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
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2008-06-04
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

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 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)

Primary outcomes:
measure: Evolution of left ventricular volumes and contractility Evolution of left ventricular volumes and contractility
Secondary outcomes:
measure: Functional status
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Departements of CardiacSurgery, Cardiology and Radiology
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Janusz Lipiecki, Dr
role: PRINCIPAL_INVESTIGATOR
References: