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

NCT ID: NCT07130721

Last Updated: 2025-08-19

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-01

Study Completion Date

2026-05-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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End Stage Renal Disease on Dialysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DIAGNOSTIC_TEST

Blood samples will be collected once from all participants to measure CRP levels

D-dimer Test

Intervention Type DIAGNOSTIC_TEST

D-dimer levels will be assessed once to evaluate thrombotic risk.

Electrocardiogram (ECG)

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Blood samples will be collected once from all participants to measure CRP levels

D-dimer Test

Intervention Type DIAGNOSTIC_TEST

D-dimer levels will be assessed once to evaluate thrombotic risk.

Electrocardiogram (ECG)

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

D-dimer Test

D-dimer levels will be assessed once to evaluate thrombotic risk.

Intervention Type DIAGNOSTIC_TEST

Electrocardiogram (ECG)

A standard 12-lead ECG will be performed once per participant to assess cardiovascular status

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mennat Allah Mahmoud Ahmed

MSc Candidate, Faculty of Medicine, Assiut University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University Hospital

Asyut, Asyut Governorate, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Mennat Allah M Ahmed, M.B.B.Ch.

Role: CONTACT

+201030830488

Other Identifiers

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04-2025-201318

Identifier Type: -

Identifier Source: org_study_id

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