Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Alcohol consumption.
- Who it may be relevant to
- Registry conditions: Myocardial Infarction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction: a Multicentre Randomized Controlled Trial
Overview
A total of 220 patients (110 per arm) who report moderate alcohol consumption between 1 and 28 standard units (1 standard unit = \~10 grams) per week in the 12 months prior to hospital admission will be planned for randomization, using a 1:1 ratio to pursue moderate alcohol consumption (1 standard unit per day for women and 2 standard units per day for men) or abstinence (except for one drink on predefined/agreed special occasions) for a total duration of 3 months. An echocardiography will be performed at baseline and 3 months to assess changes in systolic cardiac function (LVEF) for the primary endpoint. A core laboratory team blinded to assignment will perform data interpretation.
Interventions
- Behavioral Alcohol consumption
After written consent, patients will enter a run-in period of 2 weeks where they will be asked not to drink any alcohol beverage. Patients with a successful run-in period will be randomized on a 1:1 basis stratified by baseline LVEF (\<50% vs. ≥50%), sex and study site. 110 patients will be assigned to moderate alcohol consumption (1 standard unit a day), and 110 patients to abstinence (no alcohol beverages) for 3 months. We will perform a first echocardiography at randomization and a second at
Primary outcome measures
- Cardiac function [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- Hospitalization for acute ST-elevation MI (STEMI) or non ST-elevation MI (NSTEMI) within 365 days prior to screening
- Men and women aged ≥18 years who are capable and willing to provide consent
- ECG ischemic changes, such as persistent or dynamic ST-segment deviation
- Evidence of positive high-sensitive troponin
- Confirmation of coronary heart disease aetiology by angiography
- Capacity to complete study visits with strict adherence to the protocol assignment
- Self-reported average alcohol consumption of between 1 and 28 standard units per week in the 12 months prior to the index hospitalization.
Exclusion criteria
- High alcohol consumption, defined as an average of >28 alcoholic standard units/week in the 12 months prior to the index hospitalization
- Alcohol use disorder (AUDIT score >20 at screening)
- History of alcohol or substance abuse
- Naïve to alcohol consumption
- Light alcohol consumption (<1 standard units by week)
- Prior severe heart failure (NYHA III-IV)
- Severe LV dysfunction at screening (<30%)
- History of gastric ulcer or gastro-intestinal bleeding
- Serious chronic liver disease or liver test elevation (> 3 times upper limit normal range)
- Personal history of any colon or liver cancer
- Any active malignancy (less than 5 years or ongoing treatment)
- Estimated glomerular filtration rate 15 ml/min/1.73m² or end-stage renal disease
- Any medication (investigator's discretion) making study participation impractical or precluding required follow-up
- History of organ transplant
- Participation in another trial testing intervention on similar CV outcomes (investigator's discretion)
- Any medical, geographic, or social factor making study participation impractical or precluding required follow-up.
- Pregnant, breastfeeding or planning to become pregnant within 12 months.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Switzerland · 4 centers
- Universitätsspital Basel — Basel
- Inselspital — Bern
- Centre hospitalier universitaire vaudois — Lausanne
- Hôpitaux Universitaires de Genève — Geneva
Identifiers
NCT: NCT05920629 · 2022-01838