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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
Contact: Allison Caplan | 702-839-7235 | acaplan@cvbt.com |
United States, Alabama | |
Princeton Baptist Medical Center | Recruiting |
Birmingham, Alabama, United States, 35211 | |
Contact: Susan DeRamus 205-780-4330 sderamus@cardiologypc.com | |
Principal Investigator: Farrell Mendelsohn, MD | |
United States, Arizona | |
Mercy Gilbert Medical Center | Recruiting |
Gilbert, Arizona, United States, 85297 | |
Contact: Nabil Dib, MD 480-728-7086 ndib@isctr.org | |
Contact: Ann Campbell 1-480-728-7086 ann.campbell@chw.edu | |
Principal Investigator: Nabil Dib, MD | |
United States, California | |
Medical Center, University of California, San Diego | Recruiting |
San Diego, California, United States, 92103 | |
Contact: Anthony DeMaria, MD 619-543-6031 ademaria@ucsd.edu | |
Contact: Kendra Bartels 1-858-774-0206 kbartels@ucsd.edu | |
Principal Investigator: Anthony DeMaria, MD | |
United States, Florida | |
Florida Hospital and Cardiovascular Institute | Recruiting |
Orlando, Florida, United States, 32801 | |
Contact: Leann Goodwin 407-303-7556 leann.goodwin@flhosp.org | |
Principal Investigator: Andrew Taussig, MD | |
Jim Moran Heart and Vascular Research Institute | Recruiting |
Ft. Lauderdale, Florida, United States, 33308 | |
Contact: Alan Niederman, MD 954-229-8400 | |
Contact: Terri Kellerman 1-954-229-8400 terri.kellerman@holy-cross.com | |
Principal Investigator: Alan Niederman, MD | |
United States, Illinois | |
Cardiac Catheterization Labs, Rush Univ Medical Center | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Gary L. Schaer, MD 312-942-4655 gary_schaer@rush.edu | |
Contact: Charisse M. O'Neill, RN 312-942-5376 charrise_m_oneill@rush.edu | |
Principal Investigator: Gary L. Schaer, MD | |
United States, Minnesota | |
Minneapolis Heart Institute Foundation | Recruiting |
Minneapolis, Minnesota, United States, 55407 | |
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 | |
University of Cincinnati | Recruiting |
Cincinnati, Ohio, United States, 45219 | |
Contact: Stephanie Dunlap, MD 513-558-3476 dunlapse@ucmail.uc.edu | |
Contact: Ginger Conway 1-513-558-3476 conwaygg@ucmail.uc.edu | |
Principal Investigator: Stephanie Dunlap, MD | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Oscar Marroquin, MD 412-647-3611 marroquinoc@upmc.edu | |
Contact: Lisa Baxendell 1-412-802-8672 baxendelll2@upmc.edu | |
Principal Investigator: Oscar Marroquin, 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: | April 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00117936 History of Changes |
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 |
Mitogens Ischemia Arteriosclerosis Coronary Artery Disease |
Arterial Occlusive Diseases Heart Diseases Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Mitosis Modulators Vascular Diseases Arteriosclerosis |
Ischemia Pharmacologic Actions Coronary Disease Pathologic Processes Mitogens Cardiovascular Diseases Coronary Artery Disease |