Myocardial InfarctionNCT06583161
Emulation of the Moderate Alcohol and Cardiovascular Health Trial (MACH15)
An observational study of Myocardial Infarction and Ischemic Stroke, run by Harvard School of Public Health (HSPH).
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction, Ischemic Stroke, Angina Pectoris
- What is being tested?
- Moderate drinking, Quitting and Social drinking
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 503,325 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to 30 Nov 2022
- Phase
- Observational
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 40 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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%)
Who may be able to join
- 40-69 years old at enrollment
- Currently drinking
Who cannot join
- 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
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- 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
About this study
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.
Read the 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
- Being tested
- Moderate drinking, Quitting, Social drinking, Heavy/binge drinking
- Medical subject headings
- Myocardial Infarction, Ischemic Stroke, Angina Pectoris, Diabetes Mellitus, Type 2, Heart Failure, Atrial Fibrillation, Neoplasms, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate drinkingBehavioural
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]
QuittingBehavioural
No alcohol consumption
Social drinkingBehavioural
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 drinkingBehavioural
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]
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Moderate drinking | |
| Quitters | Participants who report not drinking alcohol on a repeated assessment center visit or in the web-based mental health questionnaire. Receives: 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. Receives: 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. Receives: Behavioral: Heavy/binge drinking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study startJan 2006
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 503,325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Goodarz Danaei, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583161
- Sponsor's protocol ID
- IRB23-1533
- Status last verified
- Aug 2024
- First submitted
- 28 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to the UK Biobank data can be requested via the official website https://www.ukbiobank.ac.uk.
Publications
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.
PubMed 32250171