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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Anginera, a human tissue replacement therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Anginera, a human tissue replacement therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CABG, Anginera, CAD