A Study of Anginera In Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery

NCT ID: NCT00364390

Last Updated: 2009-03-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2009-02-28

Brief Summary

This is a first in man, Phase I safety study of Anginera in adults with Left Ventricular Dysfunction (LVD) and Reversible Myocardial Ischemia undergoing a CABG procedure.

Detailed Description

A prospective, multicenter, open-label Phase I safety study of Anginera. Adults with Left Ventricular Dysfunction and reversible myocardial ischemia who are undergoing a CABG procedure, who have at least one graftable vessel and at least one coronary vessel not amenable to bypass or PCI (Percutaneous Coronary Intervention)will be recruited. Three pieces of Anginera will be placed on the area of the surface of the ventricle, including the area supplied by the vessel or vessels that cannot be bypassed, as well as surrounding myocardium. Patients will be followed for 12 months after the surgery at which Anginera is implanted.

The primary objective is to determine safety. The secondary objectives are to determine regional myocardial perfusion and regional left ventricular performance and to investigate the utility of measures of patient perception of improvement.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Anginera, a human tissue replacement therapy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients have been referred for CABG
• Left ventricular ejection fraction (LVEF) greater than 20%
• Patients have CAD involving at least two (2) coronary arteries, with at least one or more vessel(s) having disease not amenable to bypass grafting or PCI
• There is a region of myocardium served by the vessel(s) defined above that has objective evidence of multi-distribution reversible ischemia based on a 17-segment assessment of reversible defects on SPECT/Thallium.

Exclusion Criteria

Subjects meeting any of the following criteria will be excluded from the study:

1. Patient undergoing valve replacement or valve modification

2. Patient with significant or malignant ventricular arrhythmias, defined as a patient being treated for ventricular tachycardia and/or ventricular fibrillation with an implantable cardioverter/defibrillator (ICD) or a patient being treated with Amiodarone for these same tachyarrhythmias. (Note: having an implantable cardioverter/defibrillator (ICD) per se, in a patient who does not have significant or malignant ventricular arrhythmias, does not exclude the patient from this study.)

3. Patient requires urgent coronary artery bypass surgery

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theregen, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Theregen, Inc.

Principal Investigators

Bartley P Griffith, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

George Tellides, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University School of Medicine,

New Haven, Connecticut, United States

University of Maryland School of Medicine

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

ITT-101

Identifier Type: -

Identifier Source: org_study_id