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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Primary Percutaneous Coronary Intervention

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Plasma levels of Trimethylamine N-oxide (TMAO)

Time frame: baseline

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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Sep 16, 2025
Registry last updated: Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting