Status:
NOT_YET_RECRUITING
Impact of Gut Microbiota on Clinical Outcomes and Left Ventricular Remodeling After Primary Percutaneous Coronary Intervention
Lead Sponsor:
Assiut University
Conditions:
Primary Percutaneous Coronary Intervention
Eligibility:
All Genders
18-80 years
Brief Summary
Left ventricular remodeling (LVR) refers to the structural and functional changes that occur in the left ventricle following myocardial injury. These changes can include alterations in left ventricula...
Eligibility Criteria
Inclusion
- Age ≥ 18 years .
- Confirmed diagnosis of ST-elevation myocardial infarction (STEMI) and indication for PCI based on clinical guidelines.
- Patients scheduled to undergo primary PCI for STEMI.
- Ability and willingness to provide informed consent for participation and for the collection of stool samples.
- No significant comorbidities that may confound the results (e.g., chronic kidney disease, liver cirrhosis).
- No prior use of antibiotics, probiotics, or prebiotics within the last 3 months, as these may significantly alter gut microbiota composition.
- Willingness and ability to complete follow-up assessments as required by the study protocol.
- Absence of major gastrointestinal disorders (e.g., inflammatory bowel disease, gastrointestinal infections) that could affect gut microbiota.
Exclusion
- Age \< 18 years.
- Chronic Diseases:
- Chronic kidney disease (stage 3 or higher).
- Chronic liver disease (e.g., cirrhosis).
- Active malignancies.
- Acute infections or active inflammatory conditions at the time of PCI.
- Gastrointestinal Disorders:
- Inflammatory bowel disease.
- Celiac disease.
- Diverticulitis.
- Recent use of antibiotics, probiotics, or prebiotics within the last 3 months.
- Use of immunosuppressive medications or chemotherapy.
- Uncontrolled diabetes or hypertension.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT07175181
Start Date
October 1 2025
End Date
December 1 2026
Last Update
September 17 2025
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