What side effects are associated with this type of intervention?

Common treatments for Acute Kidney Injury (AKI) include supportive care such as fluid management, electrolyte balance, and avoiding nephrotoxic drugs. Side effects of these treatments can include fluid overload, electrolyte imbalances, and potential worsening of kidney function if not carefully monitored. Remote Ischemic Preconditioning (RIPC), a procedure that induces brief, non-lethal ischemia in a limb to release protective factors, has been shown to reduce the incidence of contrast-induced AKI. Known side effects of RIPC are minimal, with studies indicating it is a well-tolerated procedure with no major adverse events reported.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Acute Kidney Injury (AKI) that utilize the mechanism of Remote Ischemic Preconditioning (RIPC). However, the management of AKI generally includes supportive care such as optimizing hemodynamics, avoiding nephrotoxic agents, and ensuring adequate hydration. Some pharmacological agents like diuretics and vasopressors are used to manage complications, but they do not directly treat AKI. Research is ongoing to explore novel therapies, including RIPC, which aims to reduce ischemic damage by inducing brief, non-lethal ischemia in a limb to release protective factors.

What other types of research exist?

Promising novel alternatives to Remote Ischemic Preconditioning for Acute Kidney Injury patients include the use of molecularly targeted agents and immunotherapy. These treatments have shown potential in managing renal conditions by targeting specific pathways involved in kidney injury and repair. Additionally, advancements in the use of biomarkers for early detection and personalized treatment strategies are also emerging as promising approaches for AKI management.

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Procedure

RIPC for Acute Kidney Injury (BRICK Trial)

Q: What is the mechanism of action of this treatment?

Remote Ischemic Preconditioning (RIC) is a promising treatment for Acute Kidney Injury (AKI) that involves inducing brief, non-lethal ischemia in a limb to release protective factors. These factors help reduce ischemic damage in remote organs, including the kidneys, by improving renal blood flow, reducing inflammation, and enhancing cellular resistance to injury. This non-invasive and cost-effective approach is significant for AKI patients as it can mitigate kidney damage, promote recovery, and improve overall outcomes.

N/A

Waitlist Available

Led By Oladipupo Olafiranye, MD

Research Sponsored by Oladipupo Olafiranye, MD, MS

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Referral for cardiac catheterization and percutaneous coronary intervention

Patient with non-ST elevation myocardial infarction or unstable angina

Must not have

Unstable blood pressure (systolic blood pressure > 200 or <90 mmHg)

Peripheral vascular disease of upper limb

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24-48 hours

Summary

This trial is studying whether a treatment called remote ischemic preconditioning can help prevent contrast-induced acute kidney injury in people with non-ST elevation myocardial infarction and unstable angina.

Who is the study for?

This trial is for patients with non-ST elevation myocardial infarction or unstable angina who are scheduled for heart-related procedures and have a high risk of kidney injury from contrast media. It's not suitable for those unable to consent, with very high or low blood pressure, contrast allergies, upper limb vascular disease, existing severe kidney issues requiring dialysis, or those with certain types of vascular access points.

What is being tested?

The study is testing the effectiveness of Remote Ischemic Pre-Conditioning (RIPC) versus a sham procedure (Sham-RIPC) in preventing kidney damage after exposure to contrast media during cardiac catheterization and stent placement. Participants will be randomly assigned to one of these two groups without knowing which one they're in.

What are the potential side effects?

Since RIPC involves briefly restricting blood flow to limbs using a cuff, potential side effects may include discomfort in the limb where the cuff is applied. The sham procedure should have no side effects as it mimics RIPC without actually restricting blood flow.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am referred for a procedure to check and treat heart artery blockages.

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I have had a heart attack without ST elevation or unstable chest pain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My blood pressure is stable and not above 200 or below 90 mmHg.

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I have blood circulation problems in my arm.

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I am on dialysis for kidney failure.

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I have an arteriovenous fistula or graft in place.

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I am unable to understand and agree to the study's details.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24-48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24-48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Contrast-induced acute kidney injury

Secondary study objectives

Biomarkers study

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: RIPC GroupActive Control1 Intervention

3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes

Group II: Sham-RIPC GroupPlacebo Group1 Intervention

3 cycles of blood pressure cuff inflations to non-occlusive pressure of 10 mmHg for 5 minutes and deflation for 5 minutes (Control)

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Remote Ischemic Preconditioning (RIC) is a promising treatment for Acute Kidney Injury (AKI) that involves inducing brief, non-lethal ischemia in a limb to release protective factors. These factors help reduce ischemic damage in remote organs, including the kidneys, by improving renal blood flow, reducing inflammation, and enhancing cellular resistance to injury. This non-invasive and cost-effective approach is significant for AKI patients as it can mitigate kidney damage, promote recovery, and improve overall outcomes.

Contrast-induced acute kidney injury in interventional cardiology: Emerging evidence and unifying mechanisms of protection by remote ischemic conditioning.