AtherosclerosisAAAPILOTNCT00786279
Alcohol and Atherosclerosis Pilot Study
A study testing ethanol and Ethanol-free beverage in people with Atherosclerosis, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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 cardiovascular disease and hence in understanding the full health effects of alcohol across the population. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- ethanol and Ethanol-free beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diabetes
- Current Smoking
- Hypertension
- Family history of heart disease
- High LDL Cholesterol (>130 mg/dl)
- Low HDL CHolesterol (<40 mg/dl)
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- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
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.
Read the 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.
- Conditions
- Atherosclerosis
- Being tested
- ethanol, Ethanol-free beverage
- Keywords
- atherosclerosis
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ethanolOther
15 gm ethanol daily for 6 months
Ethanol-free beverageOther
0 grams ethanol daily for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | 150 cc daily of flavored, calorie-free beverage without alcohol Receives: Other: Ethanol-free beverage |
| 2 | Experimental | 150 cc flavored, calorie-free beverage with 15 gm ethanol daily Receives: Other: ethanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to alcohol intake and MRI examinations
Measured: 6 months
Secondary outcomes (1)
GGT
Measured: Monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionMar 2011
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Kenneth Mukamal, Beth Israel Deaconess Medical Center
- Investigators
- Kenneth J. Mukamal, MD, MPH, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786279
- Sponsor's protocol ID
- 2008P-000164 AAAPILOT
- Other IDs
- R21AA016110, 1R21AA016110
- Acronym
- AAAPILOT
- Status last verified
- Jan 2016
- First submitted
- 5 Nov 2008
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Panagiotou G, Mu L, Na B, Mukamal KJ, Mantzoros CS. Circulating irisin, omentin-1, and lipoprotein subparticles in adults at higher cardiovascular risk. Metabolism. 2014 Oct;63(10):1265-71. doi: 10.1016/j.metabol.2014.06.001. Epub 2014 Jun 9.
PubMed 25060690Mukamal KJ, Na B, Mu L, Mantzoros CS, Manning WJ, Mittleman MA. Lessons and Challenges from a 6-Month Randomized Pilot Study of Daily Ethanol Consumption: Research Methodology and Study Design. Curr Dev Nutr. 2017 Jun 15;1(7):e000505. doi: 10.3945/cdn.117.000505. eCollection 2017 Jul.
PubMed 29955710
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol and Atherosclerosis Pilot Study
- ClinicalTrials.gov ID
- NCT00786279
- Acronym / sponsor ID
- AAAPILOT / 2008P-000164 AAAPILOT
- Conditions
- Atherosclerosis
- Keywords
- atherosclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Nov 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 6 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Other: Ethanol-free beverage150 cc daily of flavored, calorie-free beverage without alcohol |
| 2 | Experimental | Other: ethanol150 cc flavored, calorie-free beverage with 15 gm ethanol daily |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diabetes
- Current Smoking
- Hypertension
- Family history of heart disease
- High LDL Cholesterol (>130 mg/dl)
Key exclusion criteria (21 listed)
- History of myocardial infarction (MI)/ heart attack within prior 6 months.
- Revascularization procedure (coronary, carotid, or peripheral)
- Stroke
- Claustrophobia
- Intolerance to previous MRI examinations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ethanol15 gm ethanol daily for 6 months | Other | 2 |
| Ethanol-free beverage0 grams ethanol daily for 6 months. | Other | 1 |
Primary outcome
Adherence to alcohol intake and MRI examinations
Time frame: 6 months
1 secondary outcome
GGT
Time frame: Monthly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
- Results publication: PubMed 25060690Panagiotou G, Mu L, Na B, Mukamal KJ, Mantzoros CS. Circulating irisin, omentin-1, and lipoprotein subparticles in adults at higher cardiovascular risk. Metabolism. 2014 Oct;63(10):1265-71. doi: 10.1016/j.metabol.2014.06.001. Epub 2014 Jun 9.
- Derived from this study: PubMed 29955710Mukamal KJ, Na B, Mu L, Mantzoros CS, Manning WJ, Mittleman MA. Lessons and Challenges from a 6-Month Randomized Pilot Study of Daily Ethanol Consumption: Research Methodology and Study Design. Curr Dev Nutr. 2017 Jun 15;1(7):e000505. doi: 10.3945/cdn.117.000505. eCollection 2017 Jul.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth J. Mukamal, MD, MPH principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ethanol and Ethanol-free beverage in people with Atherosclerosis, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to alcohol intake and MRI examinations (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00786279, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2016.