Serum Cysteine Rich Protein 61 and Cystatin C for Early Detection of Acute Kidney Injury in Patients With Heart Diseases

February 21, 2022 updated by: Shrook S. Ahmed, Assiut University

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

Not yet recruiting

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

Observational

Enrollment (Anticipated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Tahera Mohammed Kamel, Professor
  • Phone Number: +201227446166

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Informed consent
  3. 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)
  4. Patient with reduction in urine output (documented oliguria < 0.5 ml/kg/hour for > 6 hours)
  5. Patient with typical chest pain, ECG changes, Echocardiogram positive finding

Exclusion Criteria:

  1. History of nephrectomy
  2. patient with renal transplantation
  3. patient with renal replacement therapy initiated before admission
  4. patient with chronic kidney disease
  5. patient on regular haemodialysis
  6. patient known to be diabetic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

February 7, 2022

First Submitted That Met QC Criteria

February 7, 2022

First Posted (Actual)

February 16, 2022

Study Record Updates

Last Update Posted (Actual)

March 8, 2022

Last Update Submitted That Met QC Criteria

February 21, 2022

Last Verified

February 1, 2022

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)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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