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

NCT07130721 | Not Yet Recruiting

• 1 other identifier: 04-2025-201318
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End Stage Renal Disease on Dialysis

Outcome Measures

Primary Outcomes (2)

• Serum CRP level among hemodialysis patients

  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

  At baseline (one-time measurement)

• Plasma D-dimer level among hemodialysis patients

  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.

  At baseline (one-time measurement)

Secondary Outcomes (1)

• Presence of cardiovascular abnormalities on ECG

  At baseline (one-time measurement)

Study Arms (2)

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.

Diagnostic Test: C-Reactive Protein (CRP) Test; Diagnostic Test: D-dimer Test; Diagnostic Test: Electrocardiogram (ECG)

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

Diagnostic Test: C-Reactive Protein (CRP) Test; Diagnostic Test: D-dimer Test; Diagnostic Test: Electrocardiogram (ECG)

Interventions

C-Reactive Protein (CRP) Test DIAGNOSTIC_TEST

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

Hemodialysis Patients with Cardiovascular Disease; Hemodialysis Patients without Cardiovascular Disease

D-dimer Test DIAGNOSTIC_TEST

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

Hemodialysis Patients with Cardiovascular Disease; Hemodialysis Patients without Cardiovascular Disease

Electrocardiogram (ECG) DIAGNOSTIC_TEST

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

Hemodialysis Patients with Cardiovascular Disease; Hemodialysis Patients without Cardiovascular Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hemodialysis patients treated at the Hemodialysis Unit of Assiut University Hospital, including those with and without documented cardiovascular disease.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, Asyut Governorate, 71515, Egypt

Location

MeSH Terms

Interventions

Electrocardiography

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Central Study Contacts

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

CONTACT

+201030830488; Menna.15259031@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Candidate, Faculty of Medicine, Assiut University

Study Record Dates

• First Submitted: August 9, 2025
• First Posted: August 19, 2025
• Study Start: November 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)