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Sponsored by: |
Los Angeles Biomedical Research Institute |
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Information provided by: | Los Angeles Biomedical Research Institute |
ClinicalTrials.gov Identifier: | NCT00860847 |
Statement of Problem
According to the National Fire Protection Association (NFPA), 43.7% of all firefighters that died on the job experienced sudden cardiac death. The job also affords an incredible amount of stress. Cholesterol therapy has been well demonstrated to reduce coronary plaque progression. However is certainly not the only factor in evaluating for progression of coronary artery disease (CAD), and other factors must play a role. Garlic therapy has been shown to retard atherosclerosis independently.
Specific Aims:
Condition | Intervention | Phase |
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Coronary Atherosclerosis Coronary Artery Calcification Coronary Stenosis Vascular Function |
Dietary Supplement: Aged garlic extract and Coenzyme Q10 |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Firefighter Aged Garlic Extract Investigation With CoQ10 as a Treatment for Heart Disease (FAITH) |
Estimated Enrollment: | 130 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Aged Garlic Extract and Coenzyme Q10: Active Comparator
AGE (1200 mg) and CoQ10 (120 mg)
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Dietary Supplement: Aged garlic extract and Coenzyme Q10
AGE (1200 mg) and CoQ10 (120 mg)
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Placebo: No Intervention |
Inclusion Criteria
Exclusion Criteria
Outcome Measures Primary - Rate of change in total coronary calcium scores by CT
Secondary Change in blood values and endothelial function over 6 and 12 months:
Ages Eligible for Study: | 35 Years to 84 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ferdinand Flores, BS | 310-222-8015 | fflores@labiomed.org |
United States, California | |
Los Angeles Biomedical Research Institute | Recruiting |
Torrance, California, United States, 90005 | |
Contact: Ferdinand Flores, BS 310-222-8015 fflores@labiomed.org | |
Principal Investigator: Matthew J Budoff, MD |
Principal Investigator: | Matthew J Budoff, MD | University of California, Los Angeles |
Responsible Party: | Los Angeles Biomedical Research Institute ( Matthew J Budoff ) |
Study ID Numbers: | Wakunaga of America Co., Ltd. |
Study First Received: | March 11, 2009 |
Last Updated: | August 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00860847 History of Changes |
Health Authority: | United States: Institutional Review Board |
Progression of Atherosclerosis Aged garlic extract Biomarkers of inflammation Coronary Plaque Volume and coronary Stenosis Vascular function |
Atherosclerosis Arterial Occlusive Diseases Heart Diseases Myocardial Ischemia Disease Progression Vascular Diseases Trace Elements Constriction, Pathologic Arteriosclerosis Ischemia |
Coronary Stenosis Coenzyme Q10 Inflammation Coronary Disease Vitamins Ubiquinone Micronutrients Garlic Coronary Artery Disease |
Atherosclerosis Arterial Occlusive Diseases Heart Diseases Growth Substances Myocardial Ischemia Physiological Effects of Drugs Vascular Diseases Arteriosclerosis |
Coronary Stenosis Pharmacologic Actions Coenzyme Q10 Coronary Disease Vitamins Cardiovascular Diseases Micronutrients Coronary Artery Disease |