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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Age < 18 years.

Chronic kidney disease (stage 3 or higher).

Chronic liver disease (e.g., cirrhosis).

Active malignancies.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

144 Participants
are grouped into 1 trial group
Group A: Group A

Trial outcomes

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.

Time frame
baseline

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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