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临床试验/NCT07130721
NCT07130721尚未招募不适用

Assessment of Blood Biomarkers (D-dimer and C-Reactive Protein) in Predicting Cardiovascular Complications Among Hemodialysis Patients: A Cross-Sectional Study

Assiut University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年11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
100
试验地点
1
主要终点
Serum CRP level among hemodialysis patients

研究概览

简要总结

This study aims to assess whether two blood markers - C-reactive protein (CRP) and D-dimer - can help predict cardiovascular complications in patients undergoing regular hemodialysis. Cardiovascular disease is a common and serious problem in dialysis patients, and early detection is important.

the study will include 100 adult patients from the Hemodialysis Unit at Assiut University Hospital. Participants will be divided into two groups: those with and those without known heart disease. Each participant will have a one-time blood test to measure CRP and D-dimer levels. In addition, an electrocardiogram (ECG) will be done once to check for signs of heart problems.

详细描述

This cross-sectional study is designed to explore the potential role of hematologic biomarkers in predicting cardiovascular complications among patients undergoing maintenance hemodialysis. Cardiovascular disease is a leading cause of morbidity and mortality in this population, and systemic inflammation and hypercoagulability are thought to contribute significantly to adverse outcomes.

C-reactive protein (CRP) is a well-established marker of systemic inflammation, while D-dimer reflects activation of the coagulation and fibrinolytic pathways. Both biomarkers have been associated with increased cardiovascular risk in the general population, but their predictive value in hemodialysis patients remains insufficiently characterized.

A total of 100 adult patients on maintenance hemodialysis will be evaluated. The population will be stratified into two groups based on the presence or absence of clinically confirmed cardiovascular disease. Laboratory analysis will include measurement of CRP and D-dimer, and cardiovascular assessment will include a standard 12-lead ECG. Clinical and demographic data will also be collected.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Adults aged ≥18 years
  • On regular hemodialysis for at least 3 months
  • Able and willing to provide informed consent
  • Group I: Hemodialysis patients with no clinically documented cardiovascular disease
  • Group II: Hemodialysis patients with confirmed cardiovascular disease (by medical records, ECGs, echocardiography, or documented hospital admissions)

排除标准

  • Acute or recent infection (within the past 4 weeks)
  • Use of anticoagulant or antiplatelet therapy
  • Active malignancy
  • Autoimmune or chronic inflammatory disease
  • Known bleeding or thrombotic disorders

结局指标

主要结局

Serum CRP level among hemodialysis patients

时间窗: At baseline (one-time measurement)

To assess the level of serum CRP in hemodialysis patients with and without cardiovascular disease and compare values between the two groups to explore possible associations

Plasma D-dimer level among hemodialysis patients

时间窗: At baseline (one-time measurement)

To assess the level of plasma D-dimer in hemodialysis patients with and without cardiovascular disease and compare values between the two groups to explore possible associations.

次要结局

  • Presence of cardiovascular abnormalities on ECG(At baseline (one-time measurement))

研究者

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

Mennat Allah Mahmoud Ahmed

MSc Candidate, Faculty of Medicine, Assiut University

Assiut University

研究点 (1)

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