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Firefighter Aged Garlic Extract Investigation With CoQ10 as a Treatment for Heart Disease (FAITH)
This study is currently recruiting participants.
Verified by Los Angeles Biomedical Research Institute, August 2009
First Received: March 11, 2009   Last Updated: August 17, 2009   History of Changes
Sponsored by: Los Angeles Biomedical Research Institute
Information provided by: Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT00860847
  Purpose
  1. 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.

  2. Hypothesis and Specific Aims The hypothesis of this proposal is: In comparison to the placebo group, Aged Garlic Extract (AGE) therapy + Coenzyme Q10 (CoQ10) will be effective in slowing progression of coronary artery calcification (CAC) in firefighters with established atherosclerosis, independent of baseline blood pressure, statin use or other cardiovascular risk factors.

Specific Aims:

  1. Compare the effects of cholesterol lowering effects in a firefighter population of patients under the influence of Aged Garlic Extract + CoQ10 or placebo.
  2. Compare whether degree of change in atherosclerotic coronary artery plaque burden will change at a different rate under the influence of Aged Garlic Extract + CoQ10 compared to placebo treatment.
  3. Compare whether Aged Garlic Extract + CoQ10 therapy induces changes in baseline values including biological and biochemical parameters, such as LDL cholesterol, homocysteine, C-reactive protein (CRP), and endothelial function.

Condition Intervention Phase
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)

Resource links provided by NLM:


Further study details as provided by Los Angeles Biomedical Research Institute:

Primary Outcome Measures:
  • Rate of change in total coronary calcium scores by computed tomography [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1.Plasma lipids: total plasma cholesterol and triglycerides, LDL-Cholesterol, HDL-Cholesterol, and VLDL-Cholesterol determined by the precipitation method; 2. Endothelial markers and inflammation: C-reactive protein and Homocysteine, as well as GSH [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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
Aged Garlic Extract and Coenzyme Q10: Active Comparator
AGE (1200 mg) and CoQ10 (120 mg)
Dietary Supplement: Aged garlic extract and Coenzyme Q10
AGE (1200 mg) and CoQ10 (120 mg)
Placebo: No Intervention

Detailed Description:

Inclusion Criteria

  • Calcium scan with Agatston score >20
  • Age 35-84 years
  • Subjects must provide written informed consent after the scope and nature of the investigation has been explained to them
  • Subjects should be stable on their concomitant medications for at least 12 weeks prior to randomization
  • Subjects who agree to refrain from supplemental garlic or significant dietary garlic

Exclusion Criteria

  • A contraindication to Aged Garlic Extract therapy including: known hypersensitivity to drug.
  • Any unstable medical, psychiatric or substance abuse disorder that in the opinion of the investigator or principal investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
  • Weight in excess of 325 pounds
  • Bleeding disorder
  • History of myocardial infarction, stroke or life-threatening arrhythmia within the prior six months
  • Resting hypotension (a resting systolic blood pressure of <90 mm Hg) or hypertension (a resting blood pressure > 170 mm Hg or a resting diastolic blood pressure of >110 mm Hg)
  • NYHA Class III or IV heart failure
  • History of malignancy within the last 5 years (other than skin cancer) or evidence of active cancer which would require concomitant cancer chemotherapy
  • Serum creatinine > 1.4 mg/dl
  • Triglycerides > 400 at visit 1
  • Diabetic subjects with HbA1c > 12%
  • Drug or alcohol abuse, or current intake of more than 14 standard drinks per week
  • Concurrent enrollment in another placebo-controlled trial
  • Presence of metal clips (i.e. bypass patients) or intracoronary stenting that preclude accurate measure of coronary calcification
  • Partial ileal bypass or known gastrointestinal disease limiting drug absorption
  • Current intake of garlic supplement or other prohibited drug (Appendix B)
  • Current tobacco use
  • Current use of anticoagulants (except for antiplatelet agents)
  • Chronic renal failure
  • Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI

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:

  1. Plasma lipids: total plasma cholesterol and triglycerides, LDL-Cholesterol, HDL-Cholesterol, and VLDL-Cholesterol determined by the precipitation method;
  2. Endothelial markers and inflammation: C-reactive protein and Homocysteine, as well as GSH
  Eligibility

Ages Eligible for Study:   35 Years to 84 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Calcium scan with Agatston score >20
  • Age 35-84 years
  • Subjects must provide written informed consent after the scope and nature of the investigation has been explained to them
  • Subjects should be stable on their concomitant medications for at least 12 weeks prior to randomization
  • Subjects who agree to refrain from supplemental garlic or significant dietary garlic

Exclusion Criteria:

  • A contraindication to Aged Garlic Extract therapy including: known hypersensitivity to drug.
  • Any unstable medical, psychiatric or substance abuse disorder that in the opinion of the investigator or principal investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
  • Weight in excess of 325 pounds
  • Bleeding disorder
  • History of myocardial infarction, stroke or life-threatening arrhythmia within the prior six months
  • Resting hypotension (a resting systolic blood pressure of <90 mm Hg) or hypertension (a resting blood pressure > 170 mm Hg or a resting diastolic blood pressure of >110 mm Hg)
  • NYHA Class III or IV heart failure
  • History of malignancy within the last 5 years (other than skin cancer) or evidence of active cancer which would require concomitant cancer chemotherapy
  • Serum creatinine > 1.4 mg/dl
  • Triglycerides > 400 at visit 1
  • Diabetic subjects with HbA1c > 12%
  • Drug or alcohol abuse, or current intake of more than 14 standard drinks per week
  • Concurrent enrollment in another placebo-controlled trial
  • Presence of metal clips (i.e. bypass patients) or intracoronary stenting that preclude accurate measure of coronary calcification
  • Partial ileal bypass or known gastrointestinal disease limiting drug absorption
  • Current intake of garlic supplement or other prohibited drug (Appendix B)
  • Current tobacco use
  • Current use of anticoagulants (except for antiplatelet agents)
  • Chronic renal failure
  • Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00860847

Contacts
Contact: Ferdinand Flores, BS 310-222-8015 fflores@labiomed.org

Locations
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            
Sponsors and Collaborators
Los Angeles Biomedical Research Institute
Investigators
Principal Investigator: Matthew J Budoff, MD University of California, Los Angeles
  More Information

Additional Information:
Publications:
Libby P, Schoenbeck U, Mach F, Selwyn AP, Ganz P. Current concepts in cardiovascular pathology: the role of LDL cholesterol in plaque rupture and stabilization. Am J Med. 1998 Feb 23;104(2A):14S-18S. Review.
Lau BH, Li L, Yoon P. Thymic peptide protects vascular endothelial cells from hydrogen peroxide-induced oxidant injury. Life Sci. 1993;52(22):1787-96.
Weissberg PL, Bennett MR. Atherosclerosis--an inflammatory disease. N Engl J Med. 1999 Jun 17;340(24):1928-9. No abstract available.
Raggi P, Callister TQ, Shaw LJ. Progression of coronary artery calcium and risk of first myocardial infarction in patients receiving cholesterol-lowering therapy. Arterioscler Thromb Vasc Biol. 2004 Jul;24(7):1272-7. Epub 2004 Apr 1.
Budoff MJ, Takasu J, Flores FR, Niihara Y, Lu B, Lau BH, Rosen RT, Amagase H. Inhibiting progression of coronary calcification using Aged Garlic Extract in patients receiving statin therapy: a preliminary study. Prev Med. 2004 Nov;39(5):985-91.
Steiner M, Lin RS. Changes in platelet function and susceptibility of lipoproteins to oxidation associated with administration of aged garlic extract. J Cardiovasc Pharmacol. 1998 Jun;31(6):904-8.
BEUTLER E, DURON O, KELLY BM. Improved method for the determination of blood glutathione. J Lab Clin Med. 1963 May;61:882-8. No abstract available.
Mao S, Bakhsheshi H, Lu B, Liu SC, Oudiz RJ, Budoff MJ. Effect of electrocardiogram triggering on reproducibility of coronary artery calcium scoring. Radiology. 2001 Sep;220(3):707-11.
Ahmadi N, Hajsadeghi F, Gul K, Vane J, Usman N, Flores F, Nasir K, Hecht H, Naghavi M, Budoff M. Relations between digital thermal monitoring of vascular function, the Framingham risk score, and coronary artery calcium score. J Cardiovasc Comput Tomogr. 2008 Nov;2(6):382-8. Epub 2008 Sep 26.

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

Keywords provided by Los Angeles Biomedical Research Institute:
Progression of Atherosclerosis
Aged garlic extract
Biomarkers of inflammation
Coronary Plaque Volume and coronary Stenosis
Vascular function

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 10, 2009