Myocardial Infarction
Conditions
Brief summary
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
BEHAVIORALAlcohol 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 3 months' follow-up.
Sponsors
Baris Gencer
University of Bern
Swiss National Science Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac function | 3 months | Measurement of change in left ventricular ejection fraction between baseline visit and 3-month visit |
Countries
Switzerland
Contacts
CONTACTBaris Gencer, MD
PRINCIPAL_INVESTIGATORBaris Gencer, MD
CHUV
Outcome results
None listed