Alcohol and Atherosclerosis Pilot Study
Alcohol and Atherosclerosis Pilot Study
We propose a pilot study to determine the feasibility of a long-term clinical trial of
 alcohol intake on atherosclerosis, the first step in determining whether moderate drinking
 prevents cardiovascular disease and hence in understanding the full health effects of alcohol
 across the population. We will randomize 40 participants aged 55 and older to a six-month
 period of consumption of 1 glass per day of either pure alcohol (diluted to the strength of
 wine) or water. At baseline and after 6 months, we will measure several standard and novel
 cardiovascular risk markers in the blood and will perform magnetic resonance imaging to
 measure atherosclerosis of the aorta.
The feasibility of a long-term randomized trial of alcohol intake on clinical endpoints is
 uncertain. One approach that could minimize the size and duration of such a randomized trial
 would be to assess the effect of alcohol on progression of radiologically-defined
 atherosclerosis.

 We propose a proof-of-principle pilot study of the effect of longer-term alcohol intake on
 atherosclerosis. We will recruit and randomize 40 participants aged 55 and older at high risk
 for CHD to a six-month period of consumption of a single 150 ml glass per day of either 10%
 ethanol (approximating wine) or water. At baseline and after 6 months, we will assess aortic
 atherosclerosis using magnetic resonance imaging. We will determine adherence in several
 ways, including serum markers, dietary recalls, and measurement of unused beverage. The
 primary outcomes in this feasibility study will be compliance with alcohol intake and the two
 MRI examinations. As secondary outcomes, we will measure standard and novel cardiovascular
 risk markers, including inflammatory markers and measures of glucose metabolism. We will
 assess safety on a continual basis, including repeated testing of liver enzymes and blood
 counts.

 If successful, this pilot study will form the basis for a more definitive trial to determine
 the effect of alcohol intake on progression of atherosclerosis, which could itself establish
 the feasibility of even larger, longer-term studies of alcohol intake and occurrence of
 cardiovascular events.
Inclusion Criteria:

 -  Diabetes

 -  Current Smoking

 -  Hypertension

 -  Family history of heart disease

 -  High LDL Cholesterol (>130 mg/dl)

 -  Low HDL CHolesterol (<40 mg/dl)

 -  Body Mass Index of 30 kg/m^2

 -  Waist circumference greater than 40 inches for men and 35 inches for women

 -  Report intake of at least one drink in the last month

 -  Post-menopause (if woman)

 Exclusion Criteria:

 -  History of myocardial infarction (MI)/ heart attack within prior 6 months.

 -  Revascularization procedure (coronary, carotid, or peripheral)

 -  Stroke

 -  Claustrophobia

 -  Intolerance to previous MRI examinations

 -  Standard MRI contraindications (e.g. pacemaker, intra-auricular implants, or
 intracranial clips)

 -  Weight over 350 pounds

 -  Active atrial fibrillation

 -  Reports intake of more than 7 drinks per week currently, has previous or current
 history of alcohol abuse based on standard questionnaires, or who has consumed more
 than 4 drinks in one day within the last 6 months.

 -  Intolerance or allergy to alcohol consumption (includes flushing)

 -  Allergy to aspartame, acesulfame, or artificial food coloring

 -  Any severe illness expected to cause death or profound disability within 6 months

 -  Evidence of depression (as measured based on a Center for Epidemiological Studies
 Depression score of 16 or higher)

 -  History of chronic liver disease

 -  Personal history of breast or any gastrointestinal cancer, uncontrolled hypertension
 (blood pressure greater than or equal to 180/110)

 -  Chronic renal failure on dialysis

 -  Current use of Metronidazole or Warfarin

 -  Use of benzodiazepines, barbiturates, and related sedative/ hypnotics 4 or more days
 per week.

 -  Severe psychiatric illness

 -  Inability to speak English

 -  Lack of a working telephone