CClinicalTrials.gg
Not yet recruitingNCT07175181Updated Sep 17, 2025

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

An observational study in Primary Percutaneous Coronary Intervention, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-17.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
144
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Primary Percutaneous Coronary Intervention
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
144 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group A

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

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07175181
Lead sponsor
Assiut University
Responsible party
Mahmoud Gamal AbdelHakam (Residant doctor at Assiut university hospital, Assiut University) — Principal investigator
First posted
Sep 16, 2025
Start date
Oct 1, 2025 (estimated)
Primary completion
Oct 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Sep 17, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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