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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anginera, a human tissue replacement therapy | Drug |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded from the study:
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| Name | Affiliation | Role |
|---|---|---|
| Bartley P Griffith, MD | University of Maryland, Baltimore | Principal Investigator |
| George Tellides, M.D., Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine, | New Haven | Connecticut | 06519 | United States | ||
| University of Maryland School of Medicine |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Baltimore |
| Maryland |
| 21201 |
| United States |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |