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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C-Reactive Protein (CRP) Test | Diagnostic Test | Blood samples will be collected once from all participants to measure CRP levels |
|
| 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) |
| 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) |
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Inclusion Criteria:
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:
Use of anticoagulant or antiplatelet therapy
Active malignancy
Autoimmune or chronic inflammatory disease
Known bleeding or thrombotic disorders
Pregnancy
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Hemodialysis patients treated at the Hemodialysis Unit of Assiut University Hospital, including those with and without documented cardiovascular disease.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mennat Allah M Ahmed, M.B.B.Ch. | Contact | +201030830488 | Menna.15259031@med.aun.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut University Hospital | Asyut | Asyut Governorate | 71515 | Egypt |
IPD will not be shared because the study involves sensitive health data and patient confidentiality must be maintained.
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| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D-dimer Test | Diagnostic Test | D-dimer levels will be assessed once to evaluate thrombotic risk. |
|
| Electrocardiogram (ECG) | Diagnostic Test | A standard 12-lead ECG will be performed once per participant to assess cardiovascular status |
|
| D004568 | Electrodiagnosis |