Remote Ischemic Preconditioning to Prevent Contrast-Induced Kidney Injury in Diabetic Patients (P… (NCT07179874) | Clinical Trial Compass
CompletedNot Applicable
Remote Ischemic Preconditioning to Prevent Contrast-Induced Kidney Injury in Diabetic Patients (PRINCES)
71 participantsStarted 2015-02-25
Plain-language summary
This study investigates whether remote ischemic preconditioning (RIPC)-a non-invasive technique involving brief cycles of blood flow restriction to the arm-can prevent contrast-induced nephropathy (CIN) in diabetic patients undergoing coronary angiography. Diabetes mellitus increases the risk of CIN due to heightened oxidative stress and disrupted protective cellular signaling.
While previous research suggests that RIPC may activate renal protective mechanisms, its efficacy in diabetic individuals remains controversial, as metabolic and neurovascular alterations may compromise its effect. This randomized trial aims to determine whether RIPC reduces oxidative kidney damage and improves renal outcomes in this high-risk population. The study will also explore the biological basis for potential variability in response, focusing on oxidative stress biomarkers and early kidney injury indicators.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient diagnosed with diabetes mellitus.
* Age above 18 years.
* Admission to the ICU due to acute coronary syndrome.
* Indication for undergoing a coronary arteriography (either urgent or scheduled)
* Patients who received a coronary arteriography within the last 72 hours (if previously recruited, counted as new for randomization).
* Possibility to perform the RIPC maneuver without delaying the catheterization
Exclusion Criteria:
* Absence of diabetes mellitus.
* Pregnant women.
* Renal transplant recipients.
* Patients who underwent urological procedures or received intravenous contrast within the last 72 hours.
* Diagnosis of end-stage renal disease requiring hemodialysis.
* Participation in another clinical trial.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Contrast-Induced Nephropathy (CIN), defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dL from baseline within 72 hours after contrast exposure
Timeframe: Time Frame: 24, 48, and 72 hours post-contrast administration