Impact of Gut Microbiota on Clinical Outcomes and Left Ventricular Remodeling After Primary Percutaneous Coronary Intervention

NCT ID: NCT07175181

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 144 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-12-01

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 ventricular shape, size, wall thickness, and volume, which can ultimately lead to decreased cardiac function and increased risk of heart failure. The remodeling process is often maladaptive and can worsen the prognosis of patients with CAD. Recent advances in microbiome research have unveiled the critical role of gut microbiota in modulating systemic health, including cardiovascular health. The gut microbiome consists of trillions of microorganisms that engage in complex interactions with the host, influencing various physiological processes. Among these interactions is the production of metabolites that can directly affect cardiovascular physiology. Notably, Trimethylamine N-oxide (TMAO). Elevated TMAO levels have been associated with increased risk of atherosclerosis and cardiovascular events, including those following PCI. Data suggest that TMAO may promote endothelial dysfunction and enhance inflammatory pathways, thereby exacerbating vascular injury and LV remodeling. These findings indicate that the interaction between gut microbiota composition, TMAO production, and cardiovascular risk could represent a novel therapeutic target for improving patient outcomes after PCI . Understanding the dynamics of these relationships can provide critical insights into individualized treatment strategies and dietary interventions that may mitigate cardiovascular risk.

Conditions

Primary Percutaneous Coronary Intervention

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A

patients Confirmed diagnosis of ST-elevation myocardial infarction (STEMI) and indication for PCI based on clinical guidelines

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Gamal AbdelHakam

Residant doctor at Assiut university hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Microbiota PCI

Identifier Type: -

Identifier Source: org_study_id