Ischemic Heart Disease Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
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