Firefighter Aged Garlic Extract Investigation With CoQ10 as a Treatment for Heart Disease (FAITH)
Condition: Coronary Atherosclerosis; Coronary Artery Calcification; Coronary Stenosis
MeSH terms: Heart Diseases; Atherosclerosis; Coronary Stenosis; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

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 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:

        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
    

Intervention name(s): Aged garlic extract and Coenzyme Q10
Intervention type(s): Dietary Supplement
Intervention description(s): AGE (1200 mg) and CoQ10 (120 mg)
Other intervention name(s): Kyolic formula 110
Intervention MeSH terms: Ubiquinone; Coenzyme Q10
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Progression of Atherosclerosis; Aged garlic extract; Biomarkers of inflammation; Coronary Plaque Volume and coronary Stenosis; Vascular function