Alcohol and Atherosclerosis Pilot Study - Full Text View

Sponsored by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:	NCT00786279

Purpose

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.

Condition	Intervention
Atherosclerosis	Other: ethanol Other: Ethanol-free beverage

Drug Information available for: Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
Official Title:	Alcohol and Atherosclerosis Pilot Study

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:

Adherence to alcohol intake and MRI examinations [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

GGT [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	November 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator 150 cc daily of flavored, calorie-free beverage without alcohol	Other: Ethanol-free beverage 0 grams ethanol daily for 6 months.
2: Experimental 150 cc flavored, calorie-free beverage with 15 gm ethanol daily	Other: ethanol 15 gm ethanol daily for 6 months

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.

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00786279

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Stephanie Teng aaapilot@bidmc.harvard.edu
Principal Investigator: Kenneth J Mukamal
Sub-Investigator: Murray A Mittleman, MD, DrPH
Sub-Investigator: Warren Manning, MD
Sub-Investigator: Chris Mantzoros

Sponsors and Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:

Kenneth J. Mukamal, MD, MPH

Beth Israel Deaconess Medical Center

More Information

Responsible Party:	Beth Israel Deaconess Medical Center ( Kenneth J. Mukamal )
Study ID Numbers:	AAAPILOT, 1R21AA016110
Study First Received:	November 5, 2008
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00786279
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

atherosclerosis

Study placed in the following topic categories:

Arterial Occlusive Diseases
Atherosclerosis
Vascular Diseases
Arteriosclerosis
Ethanol

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Infective Agents, Local
Therapeutic Uses
Physiological Effects of Drugs

Central Nervous System Depressants
Cardiovascular Diseases
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009