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

Assiut University

Status: Not yet enrolling

Conditions: End Stage Renal Disease on Dialysis

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

Study type: Observational

Funder types: Other

Identifiers

NCT07130721

04-2025-201318

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Hemodialysis Patients without Cardiovascular Disease

Description:

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.

Treatment:

Diagnostic Test: D-dimer Test

Diagnostic Test: Electrocardiogram (ECG)

Diagnostic Test: C-Reactive Protein (CRP) Test

Hemodialysis Patients with Cardiovascular Disease

Description:

Patients undergoing regular hemodialysis for at least 3 months with confirmed cardiovascular disease based on medical records, ECGs, echocardiography, or documented hospital admissions

Treatment:

Diagnostic Test: D-dimer Test

Diagnostic Test: Electrocardiogram (ECG)

Diagnostic Test: C-Reactive Protein (CRP) Test