Emulation of the Moderate Alcohol and Cardiovascular Health Trial (MACH15)

NCT ID: NCT06583161

Last Updated: 2024-09-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 503325 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2022-11-30

Brief Summary

The aim of this study is to assess how long-term alcohol consumption influences health risks by emulating the Moderate Alcohol and Cardiovascular Health Trial (MACH15). In the first step, the protocol of the emulation of MACH15, including eligibility criteria, alcohol regimens and assignment, follow-up, endpoints, causal contrasts of interest, and statistical analysis was specified. In the second step, the investigators will emulate an adapted version of MACH15 following the specified protocol using data from the UK Biobank.

Detailed Description

Observational data suggests that alcohol consumption lowers the risk of cardiovascular disease (CVD) compared to no consumption. Whether this relationship is truly causal remains uncertain because of the inherent limitations of observational studies, including unmeasured confounding and reverse causation. Mendelian randomization studies using genes as instrumental variables for alcohol are partially protected from these biases and have found no or harmful associations between alcohol consumption and CVD.

To date, there has only been one long-term randomized controlled trial to investigate the cardiovascular effects of alcohol consumption: the Moderate Alcohol and Cardiovascular Health Trial (MACH15; NCT Number: NCT03169530). It was, however, terminated shortly after initiation. An alternative to a real randomized trial like MACH15, which must first be completed and is subject to strict eligibility criteria to ensure safety, is to use observational data to emulate a (hypothetical) pragmatic randomized trial.

In this study, the investigators will emulate an adapted version of MACH15 using observational data from the UK Biobank, a large prospective cohort study of over 500,000 participants. The cardiometabolic effects of moderate drinking vs quitting, as originally planned in MACH15, as well as the effects of social and heavy/binge drinking on CVD, type 2 diabetes, other alcohol-related health outcomes, and death will be quantified.

Conditions

Myocardial Infarction; Ischemic Stroke; Angina Pectoris; Coronary Revascularization; All-cause Mortality; Cardiovascular Death; Type 2 Diabetes; Heart Failure; Atrial Fibrillation; Cancer; Dementia; Depression; Infections; Injuries; Liver Cirrhosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Moderate drinkers

Participants who report drinking up to 16 grams of alcohol daily or almost daily on a repeated assessment center visit, or who report drinking 8-16 grams of alcohol 4 or more times per week on the web-based mental health questionnaire.

Moderate drinking

Intervention Type: BEHAVIORAL

Drink up to 16 grams of alcohol daily or almost daily \[repeated assessment center visit\] or 8-16 grams of alcohol 4 or more times per week \[web-based mental health questionnaire\]

Quitters

Participants who report not drinking alcohol on a repeated assessment center visit or in the web-based mental health questionnaire.

Quitting

Intervention Type: BEHAVIORAL

No alcohol consumption

Social drinkers

Participants who report drinking up to 16 grams of alcohol 1-2 days per week or drinking 1-3 times per month or only on special occasions on a repeated assessment center visit, or who report drinking 8-16 grams of alcohol 2-3 times per week or drinking 4 times per month or less in the web-based mental health questionnaire.

Social drinking

Intervention Type: BEHAVIORAL

Drink up to 16 grams of alcohol 1-2 days per week or drink 1-3 times per month or only on special occasions \[repeated assessment center visit\], or drink 8-16 grams of alcohol 2-3 times per week or drink 4 times per month or less \[web-based mental health questionnaire\]

Heavy/binge drinkers

Participants who report drinking more than 16 grams of alcohol daily or almost daily or drinking more than 40 grams of alcohol 1-2 days per week on a repeated assessment center visit, or who report drinking 24 grams of alcohol or more 4 or more times per week or 40 grams of alcohol or more 2-3 times per week on the web-based mental health questionnaire.

Heavy/binge drinking

Intervention Type: BEHAVIORAL

Drink more than 16 grams of alcohol daily or almost daily or more than 40 grams of alcohol 1-2 days per week \[repeated assessment center visit\], or 24 grams of alcohol or more 4 or more times per week or 40 grams of alcohol or more 2-3 times per week \[web-based mental health questionnaire\]

Interventions

Moderate drinking

Drink up to 16 grams of alcohol daily or almost daily \[repeated assessment center visit\] or 8-16 grams of alcohol 4 or more times per week \[web-based mental health questionnaire\]

Intervention Type: BEHAVIORAL

Quitting

No alcohol consumption

Intervention Type: BEHAVIORAL

Social drinking

Drink up to 16 grams of alcohol 1-2 days per week or drink 1-3 times per month or only on special occasions \[repeated assessment center visit\], or drink 8-16 grams of alcohol 2-3 times per week or drink 4 times per month or less \[web-based mental health questionnaire\]

Intervention Type: BEHAVIORAL

Heavy/binge drinking

Drink more than 16 grams of alcohol daily or almost daily or more than 40 grams of alcohol 1-2 days per week \[repeated assessment center visit\], or 24 grams of alcohol or more 4 or more times per week or 40 grams of alcohol or more 2-3 times per week \[web-based mental health questionnaire\]

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 40-69 years old at enrollment
• Currently drinking

Exclusion Criteria

• Within the six months prior to baseline, cardiovascular disease event (myocardial infarction, revascularization procedure, or stroke)
• Hospitalization due to heart failure
• History of any of the following alcohol-related conditions, confirmed by a hospital record: alcoholic cardiomyopathy, alcoholic gastritis, alcoholic liver disease, degeneration of the nervous system due to alcohol, alcoholic myopathy, alcoholic polyneuropathy, alcohol-induced acute or chronic pancreatitis, alcohol use disorder; or self-reported history of alcoholic liver disease or alcohol use disorder
• Dual antiplatelet therapy or coumarin anticoagulants
• Serious chronic liver disease (active hepatitis B or C infection) in the past 6 months before baseline
• Personal history of any colon or liver cancer
• Personal history of breast cancer
• Diagnosis of dementia
• Not willing or able to provide a signed and dated informed consent form
• Reduced alcohol compared to 10 years ago due to illness, ill health, or doctor's advice
• Self-reported poor health

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role: lead

Responsible Party

Goodarz Danaei

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Spiegelman D, Lovato LC, Khudyakov P, Wilkens TL, Adebamowo CA, Adebamowo SN, Appel LJ, Beulens JW, Coughlin JW, Dragsted LO, Edenberg HJ, Eriksen JN, Estruch R, Grobbee DE, Gulayin PE, Irazola V, Krystal JH, Lazo M, Murray MM, Rimm EB, Schrieks IC, Williamson JD, Mukamal KJ. The Moderate Alcohol and Cardiovascular Health Trial (MACH15): Design and methods for a randomized trial of moderate alcohol consumption and cardiometabolic risk. Eur J Prev Cardiol. 2020 Dec;27(18):1967-1982. doi: 10.1177/2047487320912376. Epub 2020 Apr 6.

Reference Type: BACKGROUND

PMID: 32250171 (View on PubMed)

Other Identifiers

IRB23-1533

Identifier Type: -

Identifier Source: org_study_id