Assessment of D-dimer and CRP for Cardiovascular Risk Prediction in Hemodialysis Patients (BIOCARD-HD)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: End Stage Renal Disease on Dialysis
• Intervention / Treatment: Diagnostic test: C-Reactive Protein (CRP) Test; Diagnostic test: D-dimer Test; Diagnostic test: Electrocardiogram (ECG)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Mennat Allah M Ahmed, M.B.B.Ch.; Phone Number: +201030830488; Email: Menna.15259031@med.aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Assiut University hospital
    • Principal Investigator: Mennat Allah M Ahmed, M.B.B.Ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Blood samples will be collected once from all participants to measure CRP levels; Diagnostic test: D-dimer Test; D-dimer levels will be assessed once to evaluate thrombotic risk.; Diagnostic test: 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	Diagnostic test: C-Reactive Protein (CRP) Test; Blood samples will be collected once from all participants to measure CRP levels; Diagnostic test: D-dimer Test; D-dimer levels will be assessed once to evaluate thrombotic risk.; Diagnostic test: Electrocardiogram (ECG); A standard 12-lead ECG will be performed once per participant to assess cardiovascular status

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of cardiovascular abnormalities on ECG	To assess cardiovascular status of hemodialysis patients using a standard 12-lead ECG and record the presence of abnormal findings	At baseline (one-time measurement)

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: August 9, 2025
• First Submitted That Met QC Criteria: August 16, 2025
• First Posted (Actual): August 19, 2025

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 16, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Molecular Mechanisms of Pharmacological Action; Antifibrinolytic Agents; Fibrin Modulating Agents; Hemostatics; Coagulants; Fibrin fragment D
• Other Study ID Numbers: 04-2025-201318

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared because the study involves sensitive health data and patient confidentiality must be maintained.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No