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

Oladipupo Olafiranye, MD, MS

Status: Completed

Conditions: Contrast-induced Acute Kidney Injury

Treatments: Device: Sham-RIPC; Device: RIPC

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03236441

STUDY19090247

1R21DK113486-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups

RIPC Group

Active Comparator group

Description:

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

Treatment:

Device: RIPC

Sham-RIPC Group

Sham Comparator group

Description:

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

Treatment:

Device: Sham-RIPC