Using remote ischemic preconditioning to prevent kidney injury during coronary angiograms
Effectiveness of Remote Ischemic Preconditioning for Prevention of Contrast Induced Acute Kidney Injury in Patients Undergoing Coronary Angiograms.
This study is testing if a simple treatment called remote ischemic preconditioning can help protect the kidneys from injury during coronary angiograms in patients who are at risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Texas Medical Branch, Galveston Academic / other |
| Locations | 1 site (Galveston, Texas) |
| Trial ID | NCT05147831 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of remote ischemic preconditioning (RIPC) as a preventive measure against contrast-induced acute kidney injury (CI-AKI) in patients undergoing coronary angiograms. CI-AKI is a significant risk associated with the use of contrast media during imaging procedures, leading to serious health complications. The study aims to determine if RIPC can reduce the rise in creatinine levels and the incidence of renal replacement therapy in moderate to high-risk patients. By employing a non-invasive and low-cost approach, the research seeks to establish a safe method to mitigate the risks of CI-AKI.
Who should consider this trial
Good fit: Ideal candidates include patients with renal clearance below 60 ml/min who are undergoing interventional or diagnostic procedures involving contrast media.
Not a fit: Patients on dialysis, those under 18 years old, or those with certain medical conditions that prevent RIPC will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of kidney injury in patients undergoing coronary angiograms.
How similar studies have performed: While the concept of remote ischemic preconditioning is promising, further randomized controlled trials are needed to confirm its effectiveness in preventing CI-AKI.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (1) Patients undergoing an interventional or diagnostic radiological procedure in which they receive intravascular contrast, including patients undergoing coronary angiogram +/- percutaneous coronary intervention (PCI) for all clinical indications except those indicated for primary PCI due to STEMI * (2) patients presenting with a renal clearance in the range of less than 60 ml/min/1.73 m2 but not declared ESRD * (3) Patients who are not yet recruited for other pharmacological or medical device clinical trials. Exclusion Criteria: * (1) Age \<18 years * (2) Patient on hemodialysis or peritoneal dialysis * (3) Simultaneous participation in another interventional study * (4) Percutaneous coiling/embolization procedures of the kidney * (5) Impossibility to perform RIPC, caused by pathology in both arms (e.g. dystrophy, recent trauma, chronic wounds) * (6) No written informed consent * (7) Urgent angiography in STEMI * (8) Cardiogenic shock requiring catecholamine infusion * (9) Systolic blood pressure \<80 mmHg * (10) Intra-aortic balloon counter-pulsation * (11) Contrast medium injection within the previous 30 days * (12) Expected impossibility to obtain follow-up data at 6-week follow-up * (13) Patients with Raynaud's disease
Where this trial is running
Galveston, Texas
- University of Texas- Medical Branch (UTMB) — Galveston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Salman Salehin, MD
- Email: sasalehi@utmb.edu
- Phone: +12818189321
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.