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| Sponsor: | CardioVascular BioTherapeutics, Inc. |
|---|---|
| Information provided by (Responsible Party): | CardioVascular BioTherapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00117936 |
Purpose
Treatment for no-option heart patients with coronary artery disease. Procedure includes the injection into the heart of a protein growth factor, administered by the Cordis Corp. MyoStar injection catheter, to stimulate the growth of blood vessels around blocked coronary arteries.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Disease Coronary Heart Disease Myocardial Ischemia Coronary Arteriosclerosis |
Drug: Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141) Drug: Human Recombinant Fibroblast Growth Factor-1 (FGF1-141) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Human Recombinant Fibroblast Growth Factor-1 (FGF-1) for Intramyocardial Injection for the Treatment of Coronary Heart Disease |
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141)
|
Drug: Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141)
One time injection of 2 ug/kg of FGF 1-141, via a catheter
|
|
Experimental: 2
Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141)
|
Drug: Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141)
One time injection of 20 ug/kg FGF 1-141 via a catheter
|
|
Experimental: 3
Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141)
|
Drug: Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141)
One time injection of 40 ug/kg FGF 1-141, via a catheter
|
|
Placebo Comparator: 4
Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141)
|
Drug: Human Recombinant Fibroblast Growth Factor-1 (FGF1-141)
One time injection of 0 ug/kg (placebo group), via a catheter
|
Patients with chronic, stable angina with documented coronary artery disease are eligible for the study.
Eligibility| Ages Eligible for Study: | 25 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Contacts and Locations| United States, Alabama | |
| Princeton Baptist Medical Center | |
| Birmingham, Alabama, United States, 35211 | |
| United States, Arizona | |
| Mercy Gilbert Medical Center | |
| Gilbert, Arizona, United States, 85297 | |
| United States, California | |
| Medical Center, University of California, San Diego | |
| San Diego, California, United States, 92103 | |
| United States, Florida | |
| Jim Moran Heart and Vascular Research Institute | |
| Ft. Lauderdale, Florida, United States, 33308 | |
| Florida Hospital and Cardiovascular Institute | |
| Orlando, Florida, United States, 32801 | |
| United States, Illinois | |
| Cardiac Catheterization Labs, Rush Univ Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Minnesota | |
| Minneapolis Heart Institute Foundation | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, Ohio | |
| Fairfield Cardiac Cath Lab | |
| Cincinnati, Ohio, United States, 45219 | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States, 45219 | |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Nabil Dib, MD | Mercy Gilbert Medical Center, Gilbert, AZ |
More Information
| Responsible Party: | CardioVascular BioTherapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00117936 History of Changes |
| Obsolete Identifiers: | NCT00032318 |
| Other Study ID Numbers: | CVBT-CHD07-01 |
| Study First Received: | June 30, 2005 |
| Last Updated: | August 20, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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Angiogenesis No-option heart patients Blocked coronary artery |
Revascularization FGF-1 growth factor |
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Arteriosclerosis Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Ischemia Arterial Occlusive Diseases |
Vascular Diseases Cardiovascular Diseases Pathologic Processes Mitogens Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |