CABG Combined Pedicled Omentum Wrapped Autologous Atrial Tissue Patch Cardiomyoplasty for Ischemic Cardiomyopathy
NCT ID: NCT00972114
Last Updated: 2009-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
70 participants
INTERVENTIONAL
2009-10-31
2011-12-31
Brief Summary
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Detailed Description
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The primary object of this study will be to evaluate the safety and efficacy of this novel combined surgical technique. The efficacy will be assessed changes in left ventricular ejection fraction by MRI. The secondary endpoint of the study is to assess the effects of this novel combined surgical technique on cardiac contractile function and functional outcome. The effects will be assessed on the basis of clinical status and imaging rests in 6 month follow-up after enrollment. A maximum of 60 patients between 20 and 70 years will be enrolled in the study. These participants will be randomized to receive CABG, pedicled omentum graft combined CABG, or pedicled omentum graft autologous atrial tissue patch cardiomyoplasty combined CABG. The objective evaluations will be performed at baseline and during 6 months follow-up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CABG combined cardiomyoplasty
Coronary artery bypass graft surgery combined pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty
CABG combined cardiomyoplasty
coronary artery bypass graft surgery combined pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty
CABG combined pedicled omentum graft
Coronary artery bypass graft surgery combined pedicled omentum graft
CABG combined pedicled omentum graft
Coronary artery bypass graft surgery combined pedicled omentum graft
CABG alone
Coronary artery bypass graft surgery alone
CABG alone
Coronary artery bypass graft surgery alone
Interventions
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CABG combined cardiomyoplasty
coronary artery bypass graft surgery combined pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty
CABG combined pedicled omentum graft
Coronary artery bypass graft surgery combined pedicled omentum graft
CABG alone
Coronary artery bypass graft surgery alone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
70 Years
ALL
No
Sponsors
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China National Center for Cardiovascular Diseases
OTHER_GOV
Responsible Party
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China National Center for Cardiovascular Diseases
Principal Investigators
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Shengshou Hu, MD
Role: STUDY_DIRECTOR
National Center for Cardiovascular Diseases, China
Locations
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China National Center for Cardiovascular Diseases, Cardiovascular Institute & Fuwai Hospital
Beijing, , China
Institute of cardiovascular diseases & Fuwai hospital
Beijing, , China
Countries
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Facility Contacts
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Jianfeng Hou, M.D., Ph.D.
Role: primary
Shengshou Hu, MD
Role: primary
Jianfeng Hou, MD, PhD
Role: backup
Other Identifiers
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20090903
Identifier Type: -
Identifier Source: org_study_id