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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by China National Center for Cardiovascular Diseases.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier:
NCT00972114
First received: September 3, 2009
Last updated: December 9, 2009
Last verified: December 2009

September 3, 2009
December 9, 2009
October 2009
June 2010   (final data collection date for primary outcome measure)
  • Safety of CABG combined pedicled omentum wrapped autologous atrial tissue transplantation. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Changes in left ventricular ejection fraction (LVEF) by MRI. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00972114 on ClinicalTrials.gov Archive Site
  • Changes in LVEF by echocardiography. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Changes in regional wall motion by MRI. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Changes in regional wall motion by echocardiography. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Changes in fixed perfusion defect(s) by single photon emission computed tomography. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Clinical improvements, including change in 6 minutes walk test, as determined by multiple measures. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
CABG Combined Pedicled Omentum Wrapped Autologous Atrial Tissue Patch Cardiomyoplasty for Ischemic Cardiomyopathy
Coronary Artery Bypass Graft Surgery Combined Pedicled Omentum Wrapped Autologous Atrial Tissue Patch Cardiomyoplasty for Patients With Ischemic Cardiomyopathy: a Prospective Randomized Controlled Clinical Trial

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 patch cardiomyoplasty for patients with ischemic cardiomyopathy.

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. The study hypothesis is that the combined surgical technique to perform pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty as adjunct to CABG, is safe to patients with severe ischemic heart failure and can improve regional myocardial perfusion contractility, which resulting in improved systolic and diastolic left ventricular function.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ischemic Cardiomyopathy
  • Congestive Heart Failure
  • Coronary Artery Disease
  • Procedure: CABG combined cardiomyoplasty
    coronary artery bypass graft surgery combined pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty
    Other Name: CABG combined pedicled omentum graft
  • Procedure: CABG combined pedicled omentum graft
    Coronary artery bypass graft surgery combined pedicled omentum graft
    Other Name: CABG combined pedicled omentum graft
  • Procedure: CABG alone
    Coronary artery bypass graft surgery alone
    Other Name: Coronary artery bypass graft surgery alone
  • Experimental: CABG combined cardiomyoplasty
    Coronary artery bypass graft surgery combined pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty
    Intervention: Procedure: CABG combined cardiomyoplasty
  • Active Comparator: CABG combined pedicled omentum graft
    Coronary artery bypass graft surgery combined pedicled omentum graft
    Intervention: Procedure: CABG combined pedicled omentum graft
  • Active Comparator: CABG alone
    Coronary artery bypass graft surgery alone
    Intervention: Procedure: CABG alone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
December 2011
June 2010   (final data collection date for primary outcome measure)

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.
Both
20 Years to 70 Years
No
China
 
NCT00972114
20090903
Yes
Shengshou Hu MD, FACC, China National Center for Cardiovascular Diseases
China National Center for Cardiovascular Diseases
Not Provided
Study Director: Shengshou Hu, MD National Center for Cardiovascular Diseases, China
China National Center for Cardiovascular Diseases
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP