Emulation of the Moderate Alcohol and Cardiovascular Health Trial (MACH15)
NCT Number: NCT06583161
Status: COMPLETED
Study Type: OBSERVATIONAL
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
Sponsor: Harvard School of Public Health (HSPH)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 503325
Study Design: Observational Model: |Time Perspective: p
Start Date: 2006-01
Completion Date: 2022-11-30

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.

Primary Outcome Measures: 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 Outcome Measures: Cardiovascular disease, Composite endpoint comprised of the first occurrence of a non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalization for angina, coronary/carotid revascularization, and cardiovascular death, 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, Progression among normoglycemic and pre-diabetes individuals to 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, Composite endpoint comprised of the first occurrence of a non-fatal myocardial infarction, non-fatal ischemic stroke, heart failure, atrial fibrillation, cancer (except non-melanoma skin cancer), dementia, depression, infection with hospitalization, injury with hospitalization, liver cirrhosis, type 2 diabetes, and all-cause mortality, 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 Outcome Measures: Hard cardiovascular disease or death, Composite endpoint comprised of the first occurrence of a non-fatal myocardial infarction, non-fatal ischemic stroke, and cardiovascular 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, 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, First occurrence of a 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|Non-fatal ischemic stroke, First occurrence of a non-fatal ischemic stroke, From date of baseline measurement until the date of first non-fatal ischemic stroke documented in hospital data, administrative censoring, loss to follow-up, or death, whichever came first, assessed up to 200 months|Hospitalization for angina, First hospitalization for angina, From date of baseline measurement until the date of first hospitalization for angina documented in hospital data, administrative censoring, loss to follow-up, or death, whichever came first, assessed up to 200 months|Coronary/carotid revascularization, First coronary/carotid revascularization, From date of baseline measurement until the date of first coronary/carotid revascularization documented in hospital data, administrative censoring, loss to follow-up, or death, whichever came first, assessed up to 200 months|All-cause mortality, Death, From date of baseline measurement until the date of death documented in death registry data, administrative censoring, or loss to follow-up, whichever came first, assessed up to 200 months