Assessment of D-dimer and CRP for Cardiovascular Risk Prediction in Hemodialysis Patients
NCT ID: NCT07130721
Last Updated: 2025-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2025-11-01
2026-05-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Hemodialysis Patients without Cardiovascular Disease
Patients undergoing regular hemodialysis for at least 3 months with no clinically documented cardiovascular disease. Cardiovascular status is confirmed by reviewing medical records, ECGs, and other relevant reports.
C-Reactive Protein (CRP) Test
Blood samples will be collected once from all participants to measure CRP levels
D-dimer Test
D-dimer levels will be assessed once to evaluate thrombotic risk.
Electrocardiogram (ECG)
A standard 12-lead ECG will be performed once per participant to assess cardiovascular status
Hemodialysis Patients with Cardiovascular Disease
Patients undergoing regular hemodialysis for at least 3 months with confirmed cardiovascular disease based on medical records, ECGs, echocardiography, or documented hospital admissions
C-Reactive Protein (CRP) Test
Blood samples will be collected once from all participants to measure CRP levels
D-dimer Test
D-dimer levels will be assessed once to evaluate thrombotic risk.
Electrocardiogram (ECG)
A standard 12-lead ECG will be performed once per participant to assess cardiovascular status
Interventions
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C-Reactive Protein (CRP) Test
Blood samples will be collected once from all participants to measure CRP levels
D-dimer Test
D-dimer levels will be assessed once to evaluate thrombotic risk.
Electrocardiogram (ECG)
A standard 12-lead ECG will be performed once per participant to assess cardiovascular status
Eligibility Criteria
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Inclusion Criteria
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)
Exclusion Criteria
Use of anticoagulant or antiplatelet therapy
Active malignancy
Autoimmune or chronic inflammatory disease
Known bleeding or thrombotic disorders
Pregnancy
18 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Mennat Allah Mahmoud Ahmed
MSc Candidate, Faculty of Medicine, Assiut University
Locations
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Assiut University Hospital
Asyut, Asyut Governorate, Egypt
Countries
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Central Contacts
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Other Identifiers
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04-2025-201318
Identifier Type: -
Identifier Source: org_study_id
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