Biochemical Effects of Remote Ischemic Pre-Conditioning on Contrast-induced Acute Kidney Injury (BRICK)

Biochemical and Reno-protective Effects of Remote Ischemic Pre-conditioning on Contrast-induced Acute Kidney Injury

This a prospective, double-blind, sham-controlled, randomized clinical trial to study the effects of remote ischemic preconditioning on acute kidney injury, vascular and renal biomarkers in patients with non-ST elevation myocardial infarction and unstable angina undergoing coronary angiography and/or percutaneous coronary intervention.

Study Overview

• Status: Completed
• Conditions: Contrast-induced Acute Kidney Injury
• Intervention / Treatment: Device: RIPC; Device: Sham-RIPC

Detailed Description

The BRICK study is a prospective, double-blind, sham-controlled, randomized clinical trial in patients with non-ST elevation myocardial infarction and unstable angina undergoing coronary angiography and/or percutaneous coronary intervention who are at high risk for acute kidney injury. The study will investigate the effects of remote ischemic preconditioning before cardiac catheterization on rate of acute kidney injury and novel biomarkers of renal injury/protection within 48hrs of coronary angiography and/or percutaneous coronary intervention.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • VA Pittsburgh Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient with non-ST elevation myocardial infarction or unstable angina
• Referral for cardiac catheterization and percutaneous coronary intervention
• Contrast-induced acute kidney injury risk score of ≥11

Exclusion Criteria:

• Inability to give informed consent
• unstable blood pressure (systolic blood pressure > 200 or <90 mmHg)
• History of allergy to contrast media
• Peripheral vascular disease of upper limb
• Renal disease requiring dialysis
• Placement of arteriovenous fistula and arteriovenous graft

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RIPC Group; 3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes	Device: RIPC; Remote ischemic preconditioning
Sham Comparator: Sham-RIPC Group; 3 cycles of blood pressure cuff inflations to non-occlusive pressure of 10 mmHg for 5 minutes and deflation for 5 minutes (Control)	Device: Sham-RIPC; Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Acute Kidney Injury	acute kidney injury is defined as a relative increase in serum creatinine of ≥ 0.3mg/dl within 48 hours post catheterization compared with baseline creatinine before coronary angiography.	24-48 hours post coronary angiography

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Product of Urinary (Tissue Inhibitor of Metalloproteinases 2) X (Insulin-like Growth Factor-binding Protein 7)	Novel renal biomarker. The product of urinary tissue inhibitor of metalloproteinases 2 and insulin-like growth factor-binding protein 7 is measured and reported as a single test in (ng/ml)2/1000 unit. Higher value in general indicates higher risk of acute kidney injury. The range is between 0.3 and 10.	0-48hrs
Number of Patients With Major Adverse Cardiovascular and Cerebrovascular Event	Composite outcome including rehospitalization for myocardial infarction, hospitalization for heart failure, repeat revascularization, stroke, and cardiac death.	6 months post coronary angiography
Number of Patients With Major Adverse Kidney Event	Composite outcome including persistent renal impairment, use of renal replacement therapy, and all-cause death.	6 months post coronary angiography.
Cyclic Guanylate Monophosphate (cGMP) Level	Higher level of cyclic guanylate monophosphate is associated with greater vessel dilatation and blood flow. Cyclic GMP was measured in nanomolar (nM).	0-48 Hrs

Collaborators and Investigators

• Sponsor: Oladipupo Olafiranye, MD, MS
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Oladipupo Olafiranye, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2018
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: July 27, 2017
• First Posted (Actual): August 2, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: coronary artery disease; remote ischemic conditioning; cardiac catheterization; contrast-induced nephropathy
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury; Wounds and Injuries
• Other Study ID Numbers: STUDY19090247; 1R21DK113486-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes