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 contrast-induced acute kidney injury, vascular and renal biomarkers in patients with non-ST elevation myocardial infarction and unstable angina undergoing cardiac catheterization and percutaneous coronary intervention.

Study Overview

• Status: Active, not recruiting
• 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 cardiac catheterization and percutaneous coronary intervention who are at high risk for contrast-induced acute kidney injury. The study will investigate the effects of remote ischemic preconditioning before cardiac catheterization on rate of contrast induced acute kidney injury and novel biomarkers of renal injury/protection within 48hrs of cardiac catheterization.

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

Contacts and Locations

• Study Contact: Name: MaryJo Albright, RN; Phone Number: 4122465997; Email: albrightmj2@upmc.edu
• Study Contact Backup: Name: Oussama Khalifa, MD; Phone Number: 412-647-8305; Email: khalifao3@upmc.edu

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
Contrast-induced acute kidney injury	Contrast-induced acute kidney injury is defined as a relative increase in serum creatinine of ≥ 0.3mg/dl at 48 hours post catheterization compared with initial creatinine before catheterization.	24-48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers study	Novel vascular and renal biomarkers	0-48 hours
Major Adverse Cardiovascular Event		1 month and 6 months
Major Adverse Kidney Event		1 month and 6 months

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 (Estimated): 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): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: coronary artery disease; remote ischemic conditioning; cardiac catheterization; contrast-induced nephropathy
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: PRO17070546; 1R21DK113486-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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