Actively Recruiting
Effectiveness of Remote Ischemic Preconditioning for Prevention of Contrast Induced Acute Kidney Injury in Patients Undergoing Coronary Angiograms.
Led by The University of Texas Medical Branch, Galveston · Updated on 2025-05-09
300
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The use of imaging is increasing in clinical practice, either for diagnosis or intervention. In these imaging processes, contrast medium (CM) is widely used. However, CM administration can induce contrast-induced nephropathy (CI-AKI). CI-AKI is the third most common cause of renal insufficiency, and its incidence varies from 2% to 50% depending on patient risk factors; in addition, studies have shown that CI-AKI occurs in 2% to 25% of patients undergoing coronary intervention. CI-AKI is associated with significant mortality and morbidity in patients undergoing coronary angiography or other diagnostic contrast studies. We assessed the latest promising evidence on the ability of remote ischemic preconditioning (RIPC) to reduce the incidence of CI-AKI in patients undergoing Coronary Angiogram (CA) or diagnostic contrast studies such as CT angiogram, while at the same time being a non-invasive, low cost, easy, and safe method with absence of adverse effects. However, more randomized controlled trials are needed to confirm these preliminary results. The aim of this study is to minimize the incidence of CI-AKI at the University of Texas Medical Branch (UTMB). If found to be an effective method, RIPC would help minimize the incidence of CI-AKI in all institutions across the globe, who would adopt this intervention. The primary objective: i) reduce the rise in creatinine to \< 0.5 mg/dL post-CA in moderate to high risk patients and ii) reduce the incidence of renal replacement therapy post-CA in moderate to high risk patients; iii) we also aim to establish that RIPC is safe and effective. We hypothesize that the use of RIPC, when added to standard medical therapy (pre-and post-CA hydration), will mitigate the effects of contrast on the renal vasculature and lessen the incidence of CI-AKI in moderate to high risk patients at the University of Texas Medical Branch. The use of iodinated contrast to visually enhance target vasculature is a widely used diagnostic technique that is performed daily at UTMB, and around the world, for the diagnosis and management of a variety of conditions. A common complication of this procedure is acute kidney injury (AKI), generally referred to as contrast-induced nephropathy (CI-AKI). This complication can range from an isolated rise in serum creatinine to severe renal dysfunction necessitating renal replacement therapy. The incidence of CI-AKI has been reported as approximately 2-50%, depending upon the definition and sensitivity of assay employed to assess GFR in the hospital setting. In addition, CI-AKI is associated with significant mortality and morbidity. If proven to be beneficial, RIPC will bring about a reduction in incidence of CI-AKI, and thus help to reduce hospitalization and mortality from renal etiology following a given contrast procedure.
CONDITIONS
Official Title
Effectiveness of Remote Ischemic Preconditioning for Prevention of Contrast Induced Acute Kidney Injury in Patients Undergoing Coronary Angiograms.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing an interventional or diagnostic radiological procedure involving intravascular contrast, including coronary angiogram with or without PCI, except for primary PCI due to STEMI
- Patients with renal clearance less than 60 ml/min/1.73 m2 but not diagnosed with end-stage renal disease
- Patients not participating in other pharmacological or medical device clinical trials
You will not qualify if you...
- Age under 18 years
- Patients on hemodialysis or peritoneal dialysis
- Participation in another interventional study
- Percutaneous coiling or embolization procedures of the kidney
- Inability to perform RIPC due to disease or injury in both arms
- No written informed consent provided
- Urgent angiography for STEMI
- Cardiogenic shock requiring catecholamine infusion
- Systolic blood pressure below 80 mmHg
- Use of intra-aortic balloon counter-pulsation
- Contrast medium injection within the previous 30 days
- Expected inability to obtain follow-up data at 6 weeks
- Diagnosis of Raynaud's disease
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Texas- Medical Branch (UTMB)
Galveston, Texas, United States, 77555
Actively Recruiting
Research Team
S
Salman Salehin, MD
CONTACT
K
Khaled Chatila, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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