Moderate Alcohol Consumption and Cardiac Function in Patients Recently Undergoing Myocardial Infarction: A Multicenter Randomized Controlled Trial

Switzerland (ICTRP)

ID di studio ICTRP
NCT05920629 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
Moderate alcohol consumption and heart function in patients with a recent myocardial infarction: a multicentre randomized controlled trial (BASEC)

Titolo accademico
Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction: a Multicentre Randomized Controlled Trial (ICTRP)

Titolo pubblico
Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction (ICTRP)

Malattie studiate
Myocardial Infarction (ICTRP)

Intervento studiato
Behavioral: Alcohol consumption (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor). (ICTRP)

Criteri di inclusione/esclusione
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

- Nave 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/1.73m 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. (ICTRP)

non disponibile

Endpoint primari e secondari
Cardiac function (ICTRP)

non disponibile

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
University of Bern;Swiss National Science Foundation (ICTRP)

Contatti aggiuntivi
Baris Gencer, MD;Baris Gencer, MD, baris.gencer@hcuge.ch, +4179 55 35 927, University Hospital, Geneva, (ICTRP)

ID secondari
2022-01838 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT05920629 (ICTRP)