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NCT05147831 · The University of Texas Medical Branch, Galveston

Effectiveness of Remote Ischemic Preconditioning for Prevention of Contrast Induced Acute Kidney Injury in Patients Undergoing Coronary Angiograms.

(RIP-CI-AKI)

What this study 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).

View original scientific description

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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

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

  • Galveston, Texas

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

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Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

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How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced May 9, 2025 · Source of record for eligibility and locations

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What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI) Treatment in Galveston?

Join others in Texas exploring innovative treatment options through clinical research

Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI) Treatment Options in Galveston, Texas

If you're searching for Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI) treatment in Galveston, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Galveston and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI). All study-related care is provided at no cost to participants.

Local Sites
1 locations in Texas
Now Enrolling
Up to 300 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI)?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI)

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI) Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05147831. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.