HumRes63415
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SNCTP000005494
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BASEC2022-01838
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NCT05920629
Moderate Alcohol Consumption and Cardiac Function in Patients Recently Undergoing Myocardial Infarction: A Multicenter Randomized Controlled Trial
Résumé de l'étude
Following a myocardial infarction, moderate alcohol consumption is advised to preserve cardiac functions. The project aims to study whether moderate alcohol consumption is equivalent to abstinence on cardiac function.
(BASEC)
Intervention étudiée
Participants are randomly assigned to 2 groups: you will either abstain or have moderate alcohol consumption for 3 months.
You will need to come to the hospital twice a year apart for a cardiac ultrasound (30 minutes) and will be followed monthly by phone, message, or email.
(BASEC)
Maladie en cours d'investigation
Follow-up of Myocardial Infarction
(BASEC)
Critères de participation
Adult patients who have recently undergone a myocardial infarction and report weekly alcohol consumption (1 standard unit per day for women and 2 standard units per day for men) (BASEC)
Critères d'exclusion
Relevant exclusion criteria will be abstinence or the report of less than four standard alcoholic units per week, heavy consumption (more than 28 standard units per week) or conditions that contraindicate alcohol consumption. (BASEC)
Adult patients who have recently undergone a myocardial infarction and report weekly alcohol consumption (1 standard unit per day for women and 2 standard units per day for men) (BASEC)
Critères d'exclusion
Relevant exclusion criteria will be abstinence or the report of less than four standard alcoholic units per week, heavy consumption (more than 28 standard units per week) or conditions that contraindicate alcohol consumption. (BASEC)
Lieu de l’étude
Berne, Genève, Lausanne
(BASEC)
Switzerland (ICTRP)
Sponsor
CHUV, Lausanne
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Dr Baris GENCER
+4179 55 35 927
baris.gencer@clutterchuv.chCHUV, Lausanne
(BASEC)
Informations générales
University Hospital, Geneva,
+4179 55 35 927
baris.gencer@clutterchuv.ch(ICTRP)
Informations générales
University Hospital, Geneva
+4179 55 35 927
baris.gencer@clutterchuv.ch(ICTRP)
Informations scientifiques
University Hospital, Geneva,
+4179 55 35 927
baris.gencer@clutterchuv.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Genève
(BASEC)
Date d'approbation du comité d'éthique
09.05.2023
(BASEC)
Identifiant de l'essai ICTRP
NCT05920629 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Moderate alcohol consumption and heart function in patients with a recent myocardial infarction: a multicentre randomized controlled trial (BASEC)
Titre académique
Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction: a Multicentre Randomized Controlled Trial (ICTRP)
Titre public
Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction (ICTRP)
Maladie en cours d'investigation
Myocardial Infarction (ICTRP)
Intervention étudiée
Behavioral: Alcohol consumption (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor). (ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
Cardiac function (ICTRP)
non disponible
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
University of Bern;Swiss National Science Foundation (ICTRP)
Contacts supplémentaires
Baris Gencer, MD;Baris Gencer, MD, baris.gencer@hcuge.ch, +4179 55 35 927, University Hospital, Geneva, (ICTRP)
ID secondaires
2022-01838 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05920629 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible