Status:
COMPLETED
Alcohol and Atherosclerosis Pilot Study
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Atherosclerosis
Eligibility:
All Genders
55+ years
Phase:
NA
Brief Summary
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 cardiovascula...
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 asse...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00786279
Start Date
November 1 2008
End Date
April 1 2015
Last Update
January 12 2016
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215