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

Oladipupo Olafiranye, MD, MS110 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

110

Conditions

Contrast-induced Acute Kidney Injury

Interventions

RIPCDEVICE

Remote ischemic preconditioning

Sham-RIPCDEVICE

Control

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 24-48 hours post coronary angiography

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 0-48 Hrs

Data from ClinicalTrials.gov

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