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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07130721
Acronym
BIOCARD-HD
Enrollment
100
Registered
2025-08-19
Start date
2025-11-01
Completion date
2026-05-01
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease on Dialysis

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.

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.

Interventions

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

DIAGNOSTIC_TESTC-Reactive Protein (CRP) Test

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

DIAGNOSTIC_TESTD-dimer Test

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Serum CRP level among hemodialysis patientsAt baseline (one-time measurement)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
Plasma D-dimer level among hemodialysis patientsAt baseline (one-time measurement)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.

Secondary

MeasureTime frameDescription
Presence of cardiovascular abnormalities on ECGAt baseline (one-time measurement)To assess cardiovascular status of hemodialysis patients using a standard 12-lead ECG and record the presence of abnormal findings

Countries

Egypt

Contacts

Primary ContactMennat Allah M Ahmed, M.B.B.Ch.
Menna.15259031@med.aun.edu.eg+201030830488

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026