A Study of Anginera In Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
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
1 other identifier
interventional
12
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 coronary-artery-disease
Started Apr 2006
Typical duration for phase_1 coronary-artery-disease
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 14, 2006
CompletedFirst Posted
Study publicly available on registry
August 15, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedMarch 30, 2009
March 1, 2009
2.6 years
August 14, 2006
March 27, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Theregen, Inc.lead
Study Sites (2)
Yale University School of Medicine,
New Haven, Connecticut, 06519, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bartley P Griffith, MD
University of Maryland, Baltimore
- PRINCIPAL INVESTIGATOR
George Tellides, M.D., Ph.D.
Yale University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 14, 2006
First Posted
August 15, 2006
Study Start
April 1, 2006
Primary Completion
November 1, 2008
Study Completion
February 1, 2009
Last Updated
March 30, 2009
Record last verified: 2009-03