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Clinical trial phase III, prospective, controlled, randomized, open.
We hypothesize work that patients with chronic coronary occlusion and poor myocardial viability who failed to recover ventricular function after subjecting coronary revascularization with new techniques of recanalization, could achieve an improvement of ventricular function if given further regenerative treatment with mononuclear cells from autologous bone marrow.
To test this hypothesis we designed a prospective, randomized clinical trial in patients with recanalized chronic occlusions and ventricular dysfunction.
Full description
This is a randomized, open label prospective clinical trial in which all patients diagnosed with chronic coronary occlusion in the Cardiology Department of Hospital Reina Sofía in Cordoba and Hospital Puerta del Mar in Cadiz, who meet inclusion criteria and none of the exclusion shall include and express their accordance with trial participation by signing the informed consent.
66 patients who did not improve ventricular function measured by Magnetic resonance at least 3 months after revascularization of chronic coronary occlusion will be included . The 66 patients will be randomized in one to one ratio to an intervention group that received bone marrow mononuclear cells by intracoronary autologous (0.5 to 1 x 10 9 total cells) and a control group who receive only conventional medical treatment. The two groups of patients will be followed, in the clinical trial, for 6 months. Once the test is complete, they will follow according to standard clinical practice of Cardiology hospital for at least 24 months.
Patients will be assessed by clinical and Magnetic resonance methods. All patients will be medically treated similarly with ACE inhibitors or angiotensine 1 receptor (AT1) receptor antagonists of angiotensin II, beta-blockers and diuretics.
The main objective os the study is to determine the efficacy of intracoronary infusion of mononuclear cells from autologous bone marrow in patients with chronic coronary occlusion previously revascularized with stents in terms of improved ventricular function determined by magnetic resonance.
Secondary objectives of the study are:
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Inclusion criteria
Patients who give their informed consent to participate in this clinical trial.
Patients of both sexes with atherosclerotic coronary artery disease and chronic occlusions that recanalization has been achieved successfully implanted medicated stents, and in which nevertheless persists ventricular dysfunction evaluated by magnetic resonance.
Aged between 18 and 80 years.
Magnetic resonance performed at least 3 months of recanalization, the ejection fraction patient should remain below or iqual to 45%.
Normal renal function or mild renal insufficiency with serum creatinine exceeding 2.5 mg / dl.
Normal hepatic transaminases values function < 2,5 times the upper limit of the normal range.
Hemogram and coagulation studies were within normal values, defined by:
Blood pregnancy test with negative results in the case of patients of childbearing age.
Acceptance by patients (both men and women) of childbearing age to use safe contraceptive methods throughout the study, including the six month follow-up.
Willingness and ability to implement the program of visits, treatment plan, laboratory tests, and all study procedures.
Exclusion criteria
Primary purpose
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Interventional model
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28 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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