Adipose Stromal Cells Injection in the Myocardium for Induction of Revascularization (ADMIRE)

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring STROMAL CELLS, ADIPOSE STROMAL CELLS, REVASCULARIZATION, MYOCARDIUM REVASCULARIZATION, CARDIAC SURGERY, CORONARY ARTERY DISEASE Read More

Inclusion Criteria:

• signing the Informed Consent Form (TCLE)
• the patient must be a patient with obstructive atherosclerotic coronary artery disease
• sex: both men and women are eligible-
• Age: between 18 and 80 years of age
• the patient should present clinical evidence (angina pectoris or angina equivalent) OR imaging (stress echocardiography, myocardial perfusion scintigraphy, cardiac magnetic resonance imaging) of myocardial ischemia, invasively stratified with coronary angiography
• the presence of myocardial ischemia should be confirmed by at least 2 (two) distinct diagnostic methods performed within one year of the patient's inclusion in the study
• the patient is a candidate for myocardial revascularization surgery but coronary obstructive lesions, in their entirety, are NOT amenable for surgical treatment in the opinion of the surgeon (main surgeon), depending on the anatomical type, extent or distal involvement of the lesions OR, even if they can be treated surgically as a whole, an unsatisfactory surgical outcome is anticipated in terms of functional gain (restoration of myocardial perfusion)

Exclusion Criteria:

do not meet ALL criteria for inclusion

• have a concomitant severe disease, at an advanced stage, or with an unquestionable shortening of life expectancy (<1 year), or that prevents complementary examinations and / or attendance at follow-up visits
• have a confirmed diagnosis, previous history and / or past treatment of neoplasia, of any location and staging, in the last 5 years
• being in clinical treatment or awaiting surgical treatment of neoplasia, any location and staging
• present, during the outpatient investigation, unequivocal findings of neoplasia
• have symptoms attributable exclusively to left ventricular dysfunction, although of ischemic etiology, without the evidence of current myocardial ischemia, by at least two (2) methods of evaluation
• presented severe left ventricular dysfunction as defined by transthoracic echocardiography due to the finding of a left ventricular ejection fraction <0.25 (Simpson's method)
• have a history or current diagnosis of severe ventricular arrhythmias such as sustained ventricular tachycardia unless an automatic cardioverter-defibrillator has been implanted previously
• Concurrent heart diseases of other etiologies (valvular, idiopathic, hypertensive, Chagasic, etc.).
• have a history of acute coronary syndrome (unstable angina or acute myocardial infarction) in the last 3 months
• present chronic renal failure in dialysis treatment
• have participated in other cell therapy studies in the past 2 years
• Pregnant women
• patients diagnosed with acquired immunodeficiency syndrome (AIDS)