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
  Purpose

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.


Condition Intervention Phase
Ischemic Cardiomyopathy
Congestive Heart Failure
Coronary Artery Disease
Procedure: CABG combined cardiomyoplasty
Procedure: CABG combined pedicled omentum graft
Procedure: CABG alone
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by China National Center for Cardiovascular Diseases:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: October 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CABG combined cardiomyoplasty
Coronary artery bypass graft surgery combined pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty
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
Active Comparator: CABG combined pedicled omentum graft
Coronary artery bypass graft surgery 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
Active Comparator: CABG alone
Coronary artery bypass graft surgery alone
Procedure: CABG alone
Coronary artery bypass graft surgery alone
Other Name: Coronary artery bypass graft surgery alone

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. 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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972114

Locations
China
Institute of cardiovascular diseases & Fuwai hospital Not yet recruiting
Beijing, China, 100037
Contact: Shengshou Hu, MD    0086-10-8839-8359    shengshouhu@yahoo.com   
Contact: Jianfeng Hou, MD, PhD    0086-10-8839-8359    hjf2006111@163.com   
Principal Investigator: Shengshou Hu, MD         
China National Center for Cardiovascular Diseases, Cardiovascular Institute & Fuwai Hospital Recruiting
Beijing, China, 100037
Contact: Jianfeng Hou, M.D., Ph.D.    +86 10 88398359    hjf2006111@163.com   
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Investigators
Study Director: Shengshou Hu, MD National Center for Cardiovascular Diseases, China
  More Information

No publications provided

Responsible Party: Shengshou Hu MD, FACC, China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT00972114     History of Changes
Other Study ID Numbers: 20090903
Study First Received: September 3, 2009
Last Updated: December 9, 2009
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Failure
Ischemia
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014