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Sponsored by: |
CardioVascular BioTherapeutics, Inc. |
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Information provided by: | CardioVascular BioTherapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT00117936 |
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 |
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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: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
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 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141)
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Drug: Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141)
One time injection of 2 ug/kg of FGF 1-141, via a catheter
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2: Experimental
Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141)
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Drug: Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141)
One time injection of 20 ug/kg FGF 1-141 via a catheter
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3: Experimental
Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141)
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Drug: Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141)
One time injection of 40 ug/kg FGF 1-141, via a catheter
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4: Placebo Comparator
Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141)
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Drug: Human Recombinant Fibroblast Growth Factor-1 (FGF1-141)
One time injection of 0 ug/kg (placebo group), via a catheter
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Patients with chronic, stable angina with documented coronary artery disease are eligible for the study.
Ages Eligible for Study: | 25 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria
Clinically significant ECG abnormalities that interfere with ST-T wave analysis, e.g.:
Contact: Allison Caplan | 702-839-7235 | acaplan@cvbt.com |
United States, Alabama | |
Princeton Baptist Medical Center | Recruiting |
Birmingham, Alabama, United States | |
Contact: Susan DeRamus 205-780-4330 sderamus@cardiologypc.com | |
Principal Investigator: Farrell Mendelsohn, MD | |
United States, Florida | |
Florida Hospital and Cardiovascular Institute | Recruiting |
Orlando, Florida, United States | |
Contact: Leann Goodwin 407-303-7556 leann.goodwin@flhosp.org | |
Principal Investigator: Andrew Taussig, MD | |
United States, Minnesota | |
Minneapolis Heart Institute Foundation | Recruiting |
Minneapolis, Minnesota, United States | |
Contact: Patricia Mitchell 612-863-6287 patricia.mitchell@allina.com | |
Principal Investigator: Timothy Henry, MD | |
United States, Ohio | |
Fairfield Cardiac Cath Lab | Recruiting |
Cincinnati, Ohio, United States, 45219 | |
Contact: Mary Lou Sauer, RN 513-603-8236 | |
Principal Investigator: Charlie Hattemer, MD |
Principal Investigator: | Nabil Dib, MD | Mercy Gilbert Medical Center, Gilbert, AZ |
Responsible Party: | CardioVascular BioTherapeutics ( Dr. John Jacobs, VP and COO ) |
Study ID Numbers: | CVBT-CHD07-01 |
Study First Received: | June 30, 2005 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00117936 |
Health Authority: | United States: Food and Drug Administration |
Angiogenesis No-option heart patients Blocked coronary artery |
Revascularization FGF-1 growth factor |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Ischemia Arteriosclerosis Coronary Artery Disease |
Pathologic Processes Cardiovascular Diseases |