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
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
Follow-up of Myocardial Infarction
(BASEC)
Kriterien zur Teilnahme
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)
Ausschlusskriterien
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)
Ausschlusskriterien
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)
Studienstandort
Bern, Genf, Lausanne
(BASEC)
Switzerland (ICTRP)
Sponsor
CHUV, Lausanne
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Dr Baris GENCER
+4179 55 35 927
baris.gencer@clutterchuv.chCHUV, Lausanne
(BASEC)
Allgemeine Auskünfte
University Hospital, Geneva,
+4179 55 35 927
baris.gencer@clutterchuv.ch(ICTRP)
Allgemeine Auskünfte
University Hospital, Geneva
+4179 55 35 927
baris.gencer@clutterchuv.ch(ICTRP)
Wissenschaftliche Auskünfte
University Hospital, Geneva,
+4179 55 35 927
baris.gencer@clutterchuv.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Genf
(BASEC)
Datum der Bewilligung durch die Ethikkommission
09.05.2023
(BASEC)
ICTRP Studien-ID
NCT05920629 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Moderate alcohol consumption and heart function in patients with a recent myocardial infarction: a multicentre randomized controlled trial (BASEC)
Wissenschaftlicher Titel
Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction: a Multicentre Randomized Controlled Trial (ICTRP)
Öffentlicher Titel
Moderate Alcohol Consumption and Heart Function in Patients With a Recent Myocardial Infarction (ICTRP)
Untersuchte Krankheit(en)
Myocardial Infarction (ICTRP)
Untersuchte Intervention
Behavioral: Alcohol consumption (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
Cardiac function (ICTRP)
nicht verfügbar
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
University of Bern;Swiss National Science Foundation (ICTRP)
Weitere Kontakte
Baris Gencer, MD;Baris Gencer, MD, baris.gencer@hcuge.ch, +4179 55 35 927, University Hospital, Geneva, (ICTRP)
Sekundäre IDs
2022-01838 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT05920629 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar