Status:
UNKNOWN
A Study of Anginera In Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
Lead Sponsor:
Theregen, Inc.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
35-80 years
Phase:
PHASE1
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 le...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00364390
Start Date
April 1 2006
End Date
February 1 2009
Last Update
March 30 2009
Active Locations (2)
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1
Yale University School of Medicine,
New Haven, Connecticut, United States, 06519
2
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201