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Набор скоро начнётся NCT07130721

Assessment of D-dimer and CRP for Cardiovascular Risk Prediction in Hemodialysis Patients

— Наблюдательное End Stage Renal Disease on Dialysis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: C-Reactive Protein (CRP) Test, D-dimer Test, Electrocardiogram (ECG).
Кому может быть актуально
Состояния в реестре: End Stage Renal Disease on Dialysis. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Диагностический тест C-Reactive Protein (CRP) Test
    Blood samples will be collected once from all participants to measure CRP levels
  • Диагностический тест D-dimer Test
    D-dimer levels will be assessed once to evaluate thrombotic risk.
  • Диагностический тест Electrocardiogram (ECG)
    A standard 12-lead ECG will be performed once per participant to assess cardiovascular status

Первичные конечные точки

  • Serum CRP level among hemodialysis patients [Срок оценки: At baseline (one-time measurement)]
  • Plasma D-dimer level among hemodialysis patients [Срок оценки: At baseline (one-time measurement)]
Вторичные конечные точки (1)
  • Presence of cardiovascular abnormalities on ECG [Срок оценки: At baseline (one-time measurement)]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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

Pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Египет · 1 центр
  • Assiut University Hospital — Asyut

Идентификаторы

NCT: NCT07130721 · 04-2025-201318

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗