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临床试验/NCT07175181
NCT07175181尚未招募不适用

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

Assiut University0 个研究点目标入组 144 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
144
主要终点
Plasma levels of Trimethylamine N-oxide (TMAO)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Plasma levels of Trimethylamine N-oxide (TMAO)

时间窗: baseline

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Gamal AbdelHakam

Residant doctor at Assiut university hospital

Assiut University

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