CABG Combined Pedicled Omentum Wrapped Autologous Atrial Tissue Patch Cardiomyoplasty for Ischemic Cardiomyopathy

This is an interventional treatment trial for Ischemic Cardiomyopathy Read More

Inclusion Criteria:

• Male or female;
• 20-70 years old;
• Ability to give informed consent;
• Documented severe coronary heart disease, defined as at least 70% luminal diameter narrowing of at least three major coronary artery, suited to CABG;
• Left ventricular dysfunction (LVEF) less than or equal to 35%, measured by MRI or less than or equal to 45%, measured by echocardiogram;
• Presence of reversibility, as identified by single photon emission computed tomography (SPECT) isotope protocol;
• At least 3 months since last episode of myocardial infarction;
• Without a history of abdominal operation and severe abdominal diseases;
• Negative pregnancy test (in women with childbearing potential.

Exclusion Criteria:

• Pregnant or lactating;
• A history of malignancy in the last 5 years excluding basal cell carcinoma, that has been surgically removed, with proof of surgical clean margins;
• a history of abdominal operation or severe abdominal diseases;
• Positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
• Any condition requiring immunosuppressive medication;
• Bleeding diathesis, defined as an international normalized ratio of at least 2.0 in the absence of warfarin therapy;
• Hepatic dysfunction, as defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 1.5 times the upper limit of normal range prior to study entry;
• Chronic renal insufficiency, defined as a serum creatinine level greater than 2.5 mg/dL or requiring dialysis;
• Leukocytes less than 4,000/µL or exceeding 10,000/µL;
• Platelets less than 100,000/µL;
• Hemoglobin less than 10 g/dL;
• Chronic atrial fibrillation;
• Less than 3 months since last episode of cerebral infarction;
• Implantable cardioverter-defibrillator shock within 30 days of baseline consent, and within 30 days of randomization;
• Presence of ventricular tachycardia lasting 30 seconds or more on 24-hour Holter monitor or electrocardiogram (ECG) performed during screening period;
• Patients for whom it is impossible to perform both cardiac MRI;
• Enrolled in an investigational device or drug study within the previous1 year;
• Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.