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NCT Number: NCT06459362

Serum Cystatin C for Early Detection of Acute Kidney Injury After Primary Percutaneous Coronary Intervention

This study aims to evaluate whether the serum levels of Cystatin C (CysC) can be used as early biomarkers for the identification of patients who are prone to AKI after cardiac interventional surgeries as primary percutaneous coronary intervention (PCI)

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Key information

About this study

Acute Kidney Injury (AKI) is defined as an absolute increase in serum creatinine ≥0.3 mg/dl (≥26.4 μmol/l), a percentage increase in serum creatinine ≥50% (1.5-fold from baseline), or a reduction in urine output (documented oliguria < 0.5 ml/kg/hour for > 6 hours) Serum creatinine which is considered the gold standard currently for diagnosis of AKI remains unchanged until 50% of kidney function falls down. It is affected by non-specific factors like diet, age, dehydration, muscle mass, gender, and drugs There were evidences of the association between AKI and acute coronary syndrome (ACS); First, AKI detection may be missed by cardiologists. Physicians tend to disregard mild or transient serum creatinine elevation during hospital stay for ACS, and they often attribute small serum creatinine increases to laboratory variations.

Cystatin C (CysC), a cystatin protease inhibitor, is less affected by non-specific factors. When GFR decreases, CysC begins to increase. CysC was recommended to be measured in addition to creatinine in GFR estimation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years.
  • Patient with absolute increase in serum creatinine ≥0.3 mg/dl (≥26.4 μmol/l) or with percentage increase in serum creatinine ≥50% (1.5-fold from baseline)
  • Patient with reduction in urine output (documented oliguria < 0.5 ml/kg/hour for > 6 hours)
  • Patient with typical chest pain, ECG changes, Echocardiogram positive finding

Exclusion criteria

  • History of nephrectomy
  • patient with renal transplantation
  • patient with renal replacement therapy initiated before admission
  • patient with chronic kidney disease
  • patient on regular haemodialysis
  • patient known to be diabetic

Treatment and study plan

Serum cystatin C

Diagnostic Test

Diagnostic test for detection of acute kidney injury

Primary outcomes

  1. prevention and screening for early detection of acute kidney injury

    Time frame: 2 years

    using serum levels of Cystatin C (CysC) as early biomarkers for the identification of patients who are prone to AKI after cardiac inteventional surgeries as primary percutaneous coronary intervention (PCI)

Study contacts

Contact information is provided by the study sponsor or research team.

shrouk sayed ahmed

CONTACT

[email protected]

+201123232632

shrouk sayed ahmed

CONTACT

[email protected]

01123232632

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 14, 2024
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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