Clinical trial NCT00364390: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Coronary Artery Disease
Keywords: CABG
Anginera
CAD
Lead sponsor: Theregen, Inc.
Sponsor class: INDUSTRY
First posted: 2006-08-15
Enrollment: 12
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Physical exam and interval medical history
measure: CBC and differential
measure: Serum cardiac markers-Troponin I
measure: Serum chemistries and urinalysis
measure: Resting electrocardiogram (ECG)
measure: 24 hour Holter monitor
measure: Adverse Events reporting
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine,
state: Connecticut
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Bartley P Griffith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: George Tellides, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: