NCT06459362

Brief 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)

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
14mo left

Started Jul 2024

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Jul 2024Jul 2027

First Submitted

Initial submission to the registry

May 31, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

June 14, 2024

Status Verified

June 1, 2024

Enrollment Period

2 years

First QC Date

May 31, 2024

Last Update Submit

June 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    2 years

Interventions

Serum cystatin CDIAGNOSTIC_TEST

Diagnostic test for detection of acute kidney injury

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient with typical chest pain and treated by primary percutaneous intervention

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

shrouk sayed ahmed

CONTACT

shrouk sayed ahmed

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator

Study Record Dates

First Submitted

May 31, 2024

First Posted

June 14, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

June 14, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share