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

NCT07175181 | Not Yet Recruiting

• 1 other identifier: Microbiota PCI
• Study Type: observational
• Target: 144
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Plasma levels of Trimethylamine N-oxide (TMAO)

  Measurement: Plasma levels of Trimethylamine N-oxide (TMAO) will be quantified before or after PCI, using ELISA kits or other validated methods.

  baseline

Study Arms (1)

Group A

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Residant doctor at Assiut university hospital

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09