Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
A total of 220 patients (110 per arm) who report moderate alcohol consumption between 4 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 for 12 months) or abstinence (except for one drink on predefined/agreed special occasions) for a total duration of 12 months. An echocardiography will be performed at baseline and 12 months to assess changes in systolic cardiac function (LVEF) for the primary endpoint. A core laboratory team blinded to assignment will perform data interpretation.

Official Title
-----------------
Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction: a Multicentre Randomized Controlled Trial

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Behavioral: Alcohol consumption


Participation Criteria
=================
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 4 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 (<4 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Moderate alcohol consumption<br>1 standard unit a day for 12 months | |
| Other: Abstinence<br>No alcohol beverages for 12 months | Behavioral: Alcohol consumption<br>* 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 12 months. We will perform a first echocardiography at randomization and a second at 12 months' follow-up.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac function | Measurement of change in left ventricular ejection fraction between baseline visit and 12-month visit | 12 months |