Status:
UNKNOWN
CABG Combined Pedicled Omentum Wrapped Autologous Atrial Tissue Patch Cardiomyoplasty for Ischemic Cardiomyopathy
Lead Sponsor:
China National Center for Cardiovascular Diseases
Conditions:
Ischemic Cardiomyopathy
Congestive Heart Failure
Eligibility:
All Genders
20-70 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is in a phase I/II safety and efficacy study to evaluate the clinical effect of coronary artery bypass graft (CABG) combined pedicled omentum wrapped autologous atrial tissue...
Detailed Description
This is a phase I/II, randomized controlled trial to evaluate the use of CABG combined pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty for patients with ischemic cardiomyopathy...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00972114
Start Date
October 1 2009
End Date
December 1 2011
Last Update
December 10 2009
Active Locations (2)
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1
China National Center for Cardiovascular Diseases, Cardiovascular Institute & Fuwai Hospital
Beijing, China, 100037
2
Institute of cardiovascular diseases & Fuwai hospital
Beijing, China, 100037