Status:
COMPLETED
Emulation of the Moderate Alcohol and Cardiovascular Health Trial (MACH15)
Lead Sponsor:
Harvard School of Public Health (HSPH)
Conditions:
Myocardial Infarction
Ischemic Stroke
Eligibility:
All Genders
40-69 years
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...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
503325 Patients enrolled
Trial Details
Trial ID
NCT06583161
Start Date
January 1 2006
End Date
November 30 2022
Last Update
September 3 2024
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