Firefighter Aged Garlic Extract Investigation With CoQ10 as a Treatment for Heart Disease (FAITH)

Study Overview
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Brief Summary
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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. 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: Compare the effects of cholesterol lowering effects in a firefighter population of patients under the influence of Aged Garlic Extract + CoQ10 or placebo. 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. 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.

Detailed Description
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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 The Agatston score was calculated by multiplying the lesion area (mm^2) by a density factor. The density was measured in Hounsfield units, and score of 1 for 130-199 HU, 2 for 200-299 HU, 3 for 300-399 HU, and 4 for 400 HU and greater. Secondary Change in blood values and endothelial function over 6 and 12 months: Plasma lipids: total plasma cholesterol and triglycerides, LDL-Cholesterol, HDL-Cholesterol, and VLDL-Cholesterol determined by the precipitation method; Endothelial markers and inflammation: C-reactive protein and Homocysteine, as well as GSH

Official Title
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Firefighter Aged Garlic Extract Investigation With CoQ10 as a Treatment for Heart Disease (FAITH)

Conditions
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Coronary Atherosclerosis, Coronary Artery Calcification, Coronary Stenosis

Intervention / Treatment
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* Dietary Supplement: Aged garlic extract and Coenzyme Q10


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aged Garlic Extract and Coenzyme Q10<br>AGE (1200 mg) and CoQ10 (120 mg) This is a combination of aged garlic extract and co-enzyme Q10 | Dietary Supplement: Aged garlic extract and Coenzyme Q10<br>* AGE (1200 mg) and CoQ10 (120 mg)<br>* Other names: Kyolic formula 110;|
| No Intervention: Placebo<br>placebo pills will be given | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Change in Total Coronary Calcium Scores by Computed Tomography | progression of coronary artery calcium deposits as determined by computed tomography as measured by the Agatston score: The Agatston score was calculated by multiplying the lesion area (mm^2) by a density factor. The density was measured in Hounsfield units, and score of 1 for 130-199 HU, 2 for 200-299 HU, 3 for 300-399 HU, and 4 for 400 HU and greater The endpoint is the mean change (end of study value - baseline value) in each group. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Progression of Atherosclerosis, Aged garlic extract, Biomarkers of inflammation, Coronary Plaque Volume and coronary Stenosis, Vascular function