Alcohol and Atherosclerosis Pilot Study (AAAPILOT)
Recruitment status was Active, not recruiting
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Purpose
The investigators 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. The investigators 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, the investigators 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-free beverage Other: Ethanol |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 over the course of six months ] [ Designated as safety issue: Yes ]We will be examining Gamma-glutamyltransferase blood test results.
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Experimental
150 cc flavored, calorie-free beverage with 15 gm ethanol daily
|
Other: Ethanol
15 gm ethanol daily for 6 months
|
|
Placebo Comparator: Placebo Comparator
150 cc daily of flavored, calorie-free beverage without alcohol
|
Other: Ethanol-free beverage
0 grams 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.
The investigators propose a proof-of-principle pilot study of the effect of longer-term alcohol intake on atherosclerosis. The investigators 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, the investigators will assess aortic atherosclerosis using magnetic resonance imaging. The investigators 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, the investigators will measure standard and novel cardiovascular risk markers, including inflammatory markers and measures of glucose metabolism. The investigators 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 |
Inclusion Criteria:
- Diabetes
- Current Smoking
- Hypertension
- Family history of heart disease
- History of heart disease, myocardial infarction (MI)/heart attack and/or stroke more than 6 months prior to enrollment
- 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/stroke within 6 months of enrollment
- Revascularization procedure (coronary, carotid, or peripheral) within 6 months of enrollment
- 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| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: | Kenneth Mukamal, MD | Beth Israel Deaconess Medical Center |
More Information
No publications provided
| Responsible Party: | Kenneth J. Mukamal, MD, MPH, Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT01377727 History of Changes |
| Other Study ID Numbers: | 2008P-000164 |
| Study First Received: | June 13, 2011 |
| Last Updated: | June 20, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Beth Israel Deaconess Medical Center:
|
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Anti-Infective Agents, Local Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents |
Additional relevant MeSH terms:
|
Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Ethanol Anti-Infective Agents, Local |
Central Nervous System Depressants Anti-Infective Agents Central Nervous System Agents Physiological Effects of Drugs Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013