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

NCT00972114 | Unknown Phase 1 DMC

• 1 other identifier: 20090903
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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 patch cardiomyoplasty for patients with ischemic cardiomyopathy.

Conditions

Ischemic Cardiomyopathy; Congestive Heart Failure; Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• Safety of CABG combined pedicled omentum wrapped autologous atrial tissue transplantation.

  6 months

• Changes in left ventricular ejection fraction (LVEF) by MRI.

  6 months

Secondary Outcomes (5)

• Changes in LVEF by echocardiography.

  6 months

• Changes in regional wall motion by MRI.

  6 months

• Changes in regional wall motion by echocardiography.

  6 months

• Changes in fixed perfusion defect(s) by single photon emission computed tomography.

  6 months

• Clinical improvements, including change in 6 minutes walk test, as determined by multiple measures.

  6 months

Study Arms (3)

CABG combined cardiomyoplasty

EXPERIMENTAL

Coronary artery bypass graft surgery combined pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty

Procedure: CABG combined cardiomyoplasty

CABG combined pedicled omentum graft

ACTIVE COMPARATOR

Coronary artery bypass graft surgery combined pedicled omentum graft

Procedure: CABG combined pedicled omentum graft

CABG alone

ACTIVE COMPARATOR

Coronary artery bypass graft surgery alone

Procedure: CABG alone

Interventions

CABG combined cardiomyoplasty PROCEDURE

coronary artery bypass graft surgery combined pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty

Also known as: CABG combined pedicled omentum graft

CABG combined cardiomyoplasty

CABG combined pedicled omentum graft PROCEDURE

Coronary artery bypass graft surgery combined pedicled omentum graft

CABG combined pedicled omentum graft

CABG alone PROCEDURE

Coronary artery bypass graft surgery alone

Also known as: Coronary artery bypass graft surgery alone

CABG alone

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (2)

China National Center for Cardiovascular Diseases, Cardiovascular Institute & Fuwai Hospital

Beijing, 100037, China

RECRUITING

Institute of cardiovascular diseases & Fuwai hospital

Beijing, 100037, China

NOT YET RECRUITING

MeSH Terms

Conditions

Heart Failure; Coronary Artery Disease

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Shengshou Hu, MD

  National Center for Cardiovascular Diseases, China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 3, 2009
• First Posted: September 4, 2009
• Study Start: October 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2011
• Last Updated: December 10, 2009

Record last verified: 2009-12

Locations

CN (2)