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

NCT06583161 | Completed

• 1 other identifier: IRB23-1533
• Study Type: observational
• Target: 503,325
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Cardiovascular disease or death

  Composite endpoint comprised of the first occurrence of a non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalization for angina, coronary/carotid revascularization, and all-cause mortality

  From date of baseline measurement until the date of first cardiovascular disease or death documented in hospital or death registry data, administrative censoring, or loss to follow-up, whichever came first, assessed up to 200 months

Secondary Outcomes (3)

• Cardiovascular disease

  From date of baseline measurement until the date of first cardiovascular disease documented in hospital or death registry data, administrative censoring, loss to follow-up, or death from other causes, whichever came first, assessed up to 200 months

• Type 2 diabetes

  From date of baseline measurement until the date of first type 2 diabetes documented in hospital or death registry data, administrative censoring, loss to follow-up, or death from other causes, whichever came first, assessed up to 200 months

• Alcohol-related disease or death

  From date of baseline measurement until the date of first alcohol-related disease or death documented in hospital, cancer, or death registry data, administrative censoring, or loss to follow-up, whichever came first, assessed up to 200 months

Other Outcomes (7)

• Hard cardiovascular disease or death

  From date of baseline measurement until the date of first hard cardiovascular disease or death documented in hospital or death registry data, admin. censoring, loss to follow-up, or death from other causes, whichever came first, assessed up to 200 months

• Cardiovascular death

  From date of baseline measurement until the date of cardiovascular death documented in death registry data, administrative censoring, loss to follow-up, or death from other causes, whichever came first, assessed up to 200 months

• Non-fatal myocardial infarction

  From date of baseline measurement until the date of first non-fatal myocardial infarction documented in hospital data, administrative censoring, loss to follow-up, or death, whichever came first, assessed up to 200 months

Study Arms (4)

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.

Behavioral: Moderate drinking

Quitters

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

Behavioral: Quitting

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.

Behavioral: Social drinking

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.

Behavioral: Heavy/binge drinking

Interventions

Moderate drinking 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 \[web-based mental health questionnaire\]

Moderate drinkers

Quitting BEHAVIORAL

No alcohol consumption

Quitters

Social drinking 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 \[web-based mental health questionnaire\]

Social drinkers

Heavy/binge drinking 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 \[web-based mental health questionnaire\]

Heavy/binge drinkers

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All people aged 40-69 years who were registered with the National Health Service and lived within 25 miles of one of the 22 study assessment centers in England, Wales, and Scotland were invited to participate. Overall, about 9.2 million invitations were mailed in order to recruit 503,325 participants (i.e. a response rate of 5.47%)

You may qualify if:

• years old at enrollment
• Currently drinking

You may not qualify if:

• 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

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead

Related Publications (1)

• 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.

  PMID: 32250171 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction; Ischemic Stroke; Angina Pectoris; Diabetes Mellitus, Type 2; Heart Failure; Atrial Fibrillation; Neoplasms; Dementia; Depression; Infections; Wounds and Injuries; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Arrhythmias, Cardiac; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Liver Diseases; Digestive System Diseases; Fibrosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: September 3, 2024
• Study Start: January 1, 2006
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share