Alcohol and Atherosclerosis Pilot Study (AAAPILOT)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
|Official Title:||Alcohol and Atherosclerosis Pilot Study|
- Adherence to alcohol intake and MRI examinations [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- GGT [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2008|
|Study Completion Date:||April 2015|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Placebo Comparator: 1
150 cc daily of flavored, calorie-free beverage without alcohol
Other: Ethanol-free beverage
0 grams ethanol daily for 6 months.
150 cc flavored, calorie-free beverage with 15 gm ethanol daily
15 gm ethanol daily for 6 months
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786279
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Kenneth J. Mukamal, MD, MPH||Beth Israel Deaconess Medical Center|