NCT03236441

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 2, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

March 6, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
11 months until next milestone

Results Posted

Study results publicly available

January 9, 2025

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

5 years

First QC Date

July 27, 2017

Results QC Date

March 3, 2024

Last Update Submit

January 6, 2025

Conditions

Contrast-induced Acute Kidney Injury

Keywords

remote ischemic conditioningcontrast-induced nephropathycardiac catheterizationcoronary artery disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

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

    0-48hrs

  • Number of Patients With Major Adverse Cardiovascular and Cerebrovascular Event

    6 months post coronary angiography

  • Number of Patients With Major Adverse Kidney Event

    6 months post coronary angiography.

  • Cyclic Guanylate Monophosphate (cGMP) Level

    0-48 Hrs

Study Arms (2)

RIPC Group

ACTIVE COMPARATOR

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

Device: RIPC

Sham-RIPC Group

SHAM COMPARATOR

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

Interventions

RIPCDEVICE

Remote ischemic preconditioning

RIPC Group
Sham-RIPCDEVICE

Control

Sham-RIPC Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Olafiranye O, Straub AC, Zhang Y, Chaudhary R, Miller MP, Trivedi K, Hoang L, Khalifa O, Ladejobi A, Thoma FW, Feng N, Rahman A, Kellum JA; BRICK Trial Investigators. Remote Ischemic Preconditioning Prevents Acute Kidney Injury Following Coronary Angiography: The BRICK Randomized Clinical Trial. JACC Adv. 2025 Sep;4(9):102092. doi: 10.1016/j.jacadv.2025.102092. Epub 2025 Aug 23.

    PMID: 40850057DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Limitations and Caveats

The population studied was predominantly elderly male patients with non-ST elevation myocardial infarction or unstable angina.

Results Point of Contact

Title
Oladipupo Olafiranye, MD, MS
Organization
UT Southwestern Medical Center
oladipupo.olafiranye@utsouthwestern.edu
2148572923

Study Officials

  • Oladipupo Olafiranye, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

July 27, 2017

First Posted

August 2, 2017

Study Start

March 6, 2018

Primary Completion

February 28, 2023

Study Completion

February 28, 2024

Last Updated

January 9, 2025

Results First Posted

January 9, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)