Alcohol and Atherosclerosis Pilot Study (AAAPILOT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Beth Israel Deaconess Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00786279
First received: November 5, 2008
Last updated: April 30, 2010
Last verified: April 2010
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Alcohol and Atherosclerosis Pilot Study

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

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
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

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
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Kenneth J. Mukamal, MD, MPH Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Kenneth J. Mukamal, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00786279     History of Changes
Other Study ID Numbers: AAAPILOT, R21AA016110, 1R21AA016110
Study First Received: November 5, 2008
Last Updated: April 30, 2010
Health Authority: United States: Federal Government

Keywords provided by Beth Israel Deaconess Medical Center:
atherosclerosis

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 15, 2014