Back to resultsA Study of Anginera In Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Anginera, a human tissue replacement therapy
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring CABG, Anginera, CAD
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: Patient undergoing valve replacement or valve modification 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.) Patient requires urgent coronary artery bypass surgery
Sites / Locations
- Yale University School of Medicine,
- University of Maryland School of Medicine
Outcomes
Primary Outcome Measures
Physical exam and interval medical history
CBC and differential
Serum cardiac markers-Troponin I
Serum chemistries and urinalysis
Resting electrocardiogram (ECG)
24 hour Holter monitor
Adverse Events reporting
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00364390
Brief Title
A Study of Anginera In Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
Official Title
A Phase I Open Label Pilot Study to Evaluate the Safety, Efficacy and Tolerability of Anginera for Adults With Left Ventricular Dysfunction AND Reversible Myocardial Ischemia Undergoing CABG Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2006 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
February 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Theregen, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
CABG, Anginera, CAD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Anginera, a human tissue replacement therapy
Primary Outcome Measure Information:
Title
Physical exam and interval medical history
Title
CBC and differential
Title
Serum cardiac markers-Troponin I
Title
Serum chemistries and urinalysis
Title
Resting electrocardiogram (ECG)
Title
24 hour Holter monitor
Title
Adverse Events reporting
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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:
Patient undergoing valve replacement or valve modification
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.)
Patient requires urgent coronary artery bypass surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bartley P Griffith, MD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
George Tellides, M.D., Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine,
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Anginera In Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
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