Acute Kidney InjuryNCT06459362
Serum Cystatin C for Early Detection of Acute Kidney Injury After Primary Percutaneous Coronary Intervention
An observational study of Acute Kidney Injury, run by Assiut University.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Serum cystatin C
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with typical chest pain and treated by primary percutaneous intervention
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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)
Read the detailed description
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.
- Conditions
- Acute Kidney Injury
- Being tested
- Serum cystatin C
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum cystatin CDiagnostic test
Diagnostic test for detection of acute kidney injury
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention and screening for early detection of acute kidney injury
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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shrook S. Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459362
- Sponsor's protocol ID
- SSAS
- Status last verified
- Jun 2024
- First submitted
- 31 May 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Cystatin C for Early Detection of Acute Kidney Injury After Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT06459362
- Acronym / sponsor ID
- SSAS
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with typical chest pain and treated by primary percutaneous intervention
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- History of nephrectomy
- patient with renal transplantation
- patient with renal replacement therapy initiated before admission
- patient with chronic kidney disease
- patient on regular haemodialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum cystatin CDiagnostic test for detection of acute kidney injury | Diagnostic test | – |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shrouk sayed ahmed (+201123232632, shrookabozaid@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevention and screening for early detection of acute kidney injury (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.