Alcohol and Atherosclerosis Pilot Study

Completed · Not applicable

Conditions studied: Atherosclerosis

In brief

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.

Key facts

Study ID

NCT00786279

Run by

Beth Israel Deaconess Medical Center

People needed

39

Starts

2008-11-01

Expected to finish

2015-04-01

Last updated by the study team

2016-01-12

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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