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

NCT05147831 | Recruiting

• 1 other identifier: 21-0280
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI); Contrast-induced Nephropathy Following Coronary Angiogram (CIN)

Keywords

Contrast-induced acute kidney injury (CI-AKI); Coronary angiogram; Contrast-induced nephropathy (CIN)

Outcome Measures

Primary Outcomes (1)

• Serum Creatinine

  The primary outcome would be the incidence of CI-AKI, which is defined as an increment of serum creatinine ≥ 0.5 mg/dL or a relative increase of ≥ 25% over the baseline value within a period of 48-72 hours after contrast medium administration.

  Patient's serum creatinine would be measured 48-72 hours after coronary angiogram, and re-measured 6 weeks after coronary angiogram.

Secondary Outcomes (4)

• Occurrence of re-hospitalization

  Within 6 weeks of coronary angiogram

• The need for a session of hemodialysis

  Within 6 weeks of coronary angiogram

• Mortality within 6 weeks of contrast administration

  Within 6 weeks of coronary angiogram

• Major adverse events at 6 weeks, which would comprise death from all causes, including cardiovascular death, non-fatal infarction, hemofiltration or hemodialysis, and congestive heart failure leading to hospital admission.

  Within 6 weeks of coronary angiogram

Study Arms (2)

Remote Ischemic Preconditioning Protocol

EXPERIMENTAL

Other: Remote Ischemic Preconditioning

Sham Preconditioning Protocol

NO INTERVENTION

Interventions

Remote Ischemic Preconditioning OTHER

Place blood pressure cuff around upper, non-dominant arm (e.g. upper left arm in a right-handed patient). Inflate blood pressure cuff to a pressure set at 50 mmHg higher than baseline systolic BP to induce ischemia of arm for 5 minutes. Completely deflate blood pressure cuff to allow for 5 minutes of reperfusion. Subjects would undergo 4 cycles of ischemia and reperfusion,

Remote Ischemic Preconditioning Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas- Medical Branch (UTMB)

Galveston, Texas, 77555, United States

RECRUITING

Related Publications (20)

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Central Study Contacts

Salman Salehin, MD

CONTACT

+12818189321; sasalehi@utmb.edu

Khaled Chatila, MD

CONTACT

+14436005821; kfchatil@utmb.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: December 7, 2021
• Study Start: November 30, 2021
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)