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NCT Number: NCT03236441

Biochemical 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.

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Key information

Conditions

Contrast-Induced Acute Kidney Injury Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RIPC

Device

Remote ischemic preconditioning

Sham-RIPC

Device

Control

Primary outcomes

  1. Number of Patients With Acute Kidney Injury

    Time frame: 24-48 hours post coronary angiography

    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.

Secondary outcomes

  1. The Product of Urinary (Tissue Inhibitor of Metalloproteinases 2) X (Insulin-like Growth Factor-binding Protein 7)

    Time frame: 0-48hrs

    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.

  2. Number of Patients With Major Adverse Cardiovascular and Cerebrovascular Event

    Time frame: 6 months post coronary angiography

    Composite outcome including rehospitalization for myocardial infarction, hospitalization for heart failure, repeat revascularization, stroke, and cardiac death.

  3. Number of Patients With Major Adverse Kidney Event

    Time frame: 6 months post coronary angiography.

    Composite outcome including persistent renal impairment, use of renal replacement therapy, and all-cause death.

  4. Cyclic Guanylate Monophosphate (cGMP) Level

    Time frame: 0-48 Hrs

    Higher level of cyclic guanylate monophosphate is associated with greater vessel dilatation and blood flow. Cyclic GMP was measured in nanomolar (nM).

Sponsors and collaborators

Lead sponsor

Oladipupo Olafiranye, MD, MS

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Acronym: BRICK

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Aug 2, 2017
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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