- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05242705
Serum Cysteine Rich Protein 61 and Cystatin C for Early Detection of Acute Kidney Injury in Patients With Heart Diseases
Serum Cysteine Rich Protein 61 and Cystatin C for Early Detection of Acute Kidney Injury in Patients With Acute Coronary Syndromes
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) S.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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cystatin C (CysC), a cystatin protease inhibitor, is less affected by non-specific factors. When glomerular filtration rate (GFR) decreases, CysC begins to increase.
CysC was recommended to be measured in addition to creatinine in GFR estimation.
Cysteine-rich protein 61 (Cyr61) is a cysteine-rich secretory protein that promotes cell proliferation, adhesion, chemotaxis, embryonic development and neovascularization . Previous studies have detected low expression level of Cyr61 in normal adult kidney and high expression of Cyr61 in ischemic rats and mice kidney, which suggests that Cyr61 may be a potential biomarker for diagnosis of AKI . CYR61 might possibly identify patients with more severe kidney injury, which would be very beneficial for early treatment of AKI after
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Heba Ahmed Abd El Hafeez, Professor
- Phone Number: +201006268407
- Email: dr_heba.ahmed@yahoo.com
Study Contact Backup
- Name: Tahera Mohammed Kamel, Professor
- Phone Number: +201227446166
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18 years.
- Informed consent
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Early detection of acute kidney injury in patient with acute coronary syndromes after cardiac interventional surgeries as primary percutaneous coronary intervention (PCI)
Time Frame: 3 years
|
Early detection of acute kidney injury in patient with acute coronary syndromes after cardiac interventional surgeries as primary percutaneous coronary intervention (PCI)
|
3 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Marenzi G, Cosentino N, Bartorelli AL. Acute kidney injury in patients with acute coronary syndromes. Heart. 2015 Nov;101(22):1778-85. doi: 10.1136/heartjnl-2015-307773. Epub 2015 Aug 4.
- Zhang Z, Lu B, Sheng X, Jin N. Cystatin C in prediction of acute kidney injury: a systemic review and meta-analysis. Am J Kidney Dis. 2011 Sep;58(3):356-65. doi: 10.1053/j.ajkd.2011.02.389. Epub 2011 May 20. Erratum In: Am J Kidney Dis. 2012 Apr;59(4):590-2.
- Shlipak MG, Mattes MD, Peralta CA. Update on cystatin C: incorporation into clinical practice. Am J Kidney Dis. 2013 Sep;62(3):595-603. doi: 10.1053/j.ajkd.2013.03.027. Epub 2013 May 20.
- Mosa OF, Skitek M, Kalisnik JM, Jerin A. Evaluation of serum cysteine-rich protein 61 and cystatin C levels for assessment of acute kidney injury after cardiac surgery. Ren Fail. 2016 Jun;38(5):699-705. doi: 10.3109/0886022X.2016.1157747. Epub 2016 Mar 16.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHSAS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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