Actively Recruiting
Development of a Biomarker Panel for the Earlier Prediction of Acute Kidney Injury in Patients With Diabetes Mellitus Undergoing Coronary Revascularisation
Led by Barts & The London NHS Trust · Updated on 2024-12-10
250
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on patients with diabetes mellitus who have a higher risk of kidney failure after using dye during heart artery procedures like percutaneous coronary intervention (PCI). Diabetes significantly increases the chance of developing contrast induced nephropathy (CIN), which can raise mortality within one year. The study aims to find new biomarkers that detect CIN earlier than current methods, improving safety and outcomes for this high-risk group. The study observes diabetic patients with reduced kidney function (eGFR <60 ml/min) undergoing planned PCI. Blood and urine samples will be collected before the procedure, then at 2, 4, 8 to 12 hours, before discharge, and 3 days post-procedure. These samples will be analyzed to identify biomarkers that could predict CIN development within 72 hours after the procedure. Participants will follow their usual care during the hospital stay while providing additional blood and urine samples. Researchers will monitor creatinine levels and biomarker presence to assess kidney injury risk. The main outcome is defined as an increase in creatinine of 44 micromol/l or more within 72 hours after PCI. This observational study includes about 250 patients and aims to improve early diagnosis and treatment of CIN in diabetic patients undergoing coronary revascularization.
CONDITIONS
Brief Title
Development of a Biomarker Panel for the Earlier Prediction of Acute Kidney Injury in Patients With Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Known diabetes mellitus or blood markers indicating probable diabetes
- Reduced kidney function with eGFR less than 60 ml/min
- Scheduled to undergo a percutaneous coronary intervention (PCI) procedure
- Willing to provide additional blood and urine samples as required
- Agrees to allow access to medical records for data collection
- No history or signs of drug abuse
- Able to understand and sign informed consent
- Willing and able to follow study protocol requirements
You will not qualify if you...
- Cardiogenic shock
- Pregnancy
- Receiving renal replacement therapy such as dialysis or kidney transplant
- Known significant infections like HIV, Hepatitis, or tuberculosis
- Unable to give informed consent before the procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo a planned percutaneous coronary intervention (PCI) procedure as part of their routine care. Blood and urine samples are collected before the procedure and at multiple time points after the procedure to identify biomarkers for earlier prediction of acute kidney injury.
1 day with multiple sample collections before and after PCI
Duration - Up to 3 days post-procedure
Participants are monitored for the development of acute kidney injury for up to 72 hours after the PCI procedure through additional sample collections and medical record review.
Additional sample collections up to 3 days after PCI
Trial Site Locations
Total: 1 location
1
The London Chest Hospital
London, United Kingdom, E2 9JX
Actively Recruiting
Research Team
A
AKHIL KAPUR
K
KATIE QURESHI
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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