Alcohol and Atherosclerosis Pilot Study (AAAPILOT)

January 11, 2016 updated by: Kenneth Mukamal, Beth Israel Deaconess Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
150 cc daily of flavored, calorie-free beverage without alcohol
Other: Ethanol-free beverage
0 grams ethanol daily for 6 months.
Experimental: 2
150 cc flavored, calorie-free beverage with 15 gm ethanol daily
Other: ethanol
15 gm ethanol daily for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adherence to alcohol intake and MRI examinations
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
GGT
Time Frame: Monthly
Monthly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Kenneth J. Mukamal, MD, MPH, Beth Israel Deaconess Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

November 5, 2008

First Submitted That Met QC Criteria

November 5, 2008

First Posted (Estimate)

November 6, 2008

Study Record Updates

Last Update Posted (Estimate)

January 12, 2016

Last Update Submitted That Met QC Criteria

January 11, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008P-000164 AAAPILOT
  • R21AA016110 (U.S. NIH Grant/Contract)
  • 1R21AA016110 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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