CompletedNot Applicable

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

503,325 participantsStarted 2006-01

Plain-language 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.

Who can participate

Age range40 Years – 69 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Cardiovascular disease or death

Timeframe: 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

Trial details

NCT IDNCT06583161

SponsorHarvard School of Public Health (HSPH)

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-11-30