Gut Microbiota Modulation With Synbiotics After Acute Coronary Syndrome

Korábbi kezelés

• Known or suspected non-compliance, drug or alcohol abuse, dement patients not living in assisted nurse facility care or without supervised treatment administration
• Previous enrolment into the current study,

Más betegség

• Contraindications to symbiotics as listed in Section 3.5.5, that is: immunocompromised individuals, intensive care patients (or critical state), severe valvulopathiesvalvular heart diseases, endocarditis antecedent, known allergy, chronic intestinal diseases or risk factors for small intestine bacterial overgrowth (SIBO) (severe malabsorption or history of digestive surgery), or severe comorbidities (see under)
• Limited life expectancy (<1 year) or progressive malignant disease
• Type 2 myocardial infarction: Detection of a rise and/or fall of cTn values with at least one value above the 99th percentile URL, and evidence of an imbalance between myocardial oxygen supply and demand unrelated to acute coronary athero-thrombosis, requiring at least one of the following: Symptoms of acute myocardial ischaemia; New ischaemic ECG changes; Development of pathological Q waves; Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischaemic aetiology.
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,

Laborértékek

• Severe hepatic or renal dysfunction (defined as eGFR <30 mL/min/1,73 m², dialysis or Child-Pugh score class C)

Egyéb

• Ongoing pre/probiotic supplementation
• Chronic antibiotherapy or within less than 3 months
• Women who are pregnant or breast feeding
• Intention to become pregnant during the course of the study
• Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases (Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential)
• Enrolment of the investigator, his/her family members, employees and other dependent persons

• Informed Consent as documented by signature
• Adult patients capable of providing discernment informed consent
• Recent (< 1 week) diagnosis of acute coronary syndrome as defined in the last 2023 ESC guidelines and the Fourth universal definition of myocardial infarction, including unstable angina or myocardial infarction with or without ST-elevation, managed either with best guideline-directed medical therapy or percutaneous coronary intervention.
  • Myocardial injury: Elevated cardiac troponins (cTn) value above the 99th percentile URL. The injury is considered acute if there is a rise and/or fall of cTn values.
  • Unstable angina: Myocardial ischaemia at rest or on minimal exertion in the absence of acute cardiomyocyte injury/necrosis. Prolonged (>20 min) angina at rest; new onset of severe angina; angina that is increasing in frequency, longer in duration, or lower in threshold; or angina that occurs after a recent episode of MI
  • Type 1 myocardial infarction: Detection of a rise and/or fall of cTn values with at least one value above the 99th percentile URL and with at least one of the following: Symptoms of acute myocardial ischaemia; New ischaemic ECG change; Development of pathological Q waves; Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischaemic aetiology;Identification of a coronary thrombus by angiography including intracoronary imaging or by autopsy
• Mastering French or German or capacity to be helped with adequate translation