CClinicalTrials.gg
CompletedNCT03236441BRICKUpdated Jan 9, 2025Results posted

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

An interventional study of RIPC and Sham-RIPC in Contrast-induced Acute Kidney Injury, sponsored by Oladipupo Olafiranye, MD, MS. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-09.

Sponsored by Oladipupo Olafiranye, MD, MS · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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 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.

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Conditions studied

  • Contrast-induced Acute Kidney Injury

Keywords

  • remote ischemic conditioning
  • contrast-induced nephropathy
  • cardiac catheterization
  • coronary artery disease
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In context

Acute Kidney Injury

1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's enrollment of 110 is close to the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

This is the only study on the registry with Oladipupo Olafiranye, MD, MS as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
110 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceRIPC

    Remote ischemic preconditioning

  • DeviceSham-RIPC

    Control

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What researchers measure

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.

    Time frame: 24-48 hours post coronary angiography

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

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Results

Posted Jan 9, 2025
Limitations and caveats
The population studied was predominantly elderly male patients with non-ST elevation myocardial infarction or unstable angina.

Participant flow

Participant flow — Overall Study
MilestoneRIPC GroupSham-RIPC Group
Started5455
Completed5455
Not completed00

Outcome measures

PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Patients With Acute Kidney Injury
ParticipantsRIPC GroupSham-RIPC Group
Number of Patients With Acute Kidney Injury816
SecondaryThe 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
Reported as:
Mean · (ng/ml)2/1000
The Product of Urinary (Tissue Inhibitor of Metalloproteinases 2) X (Insulin-like Growth Factor-binding Protein 7)
(ng/ml)2/1000RIPC GroupSham-RIPC Group
Baseline0.39 ± 0.510.51 ± 0.51
Post RIPC/Sham-RIPC0.71 ± 1.58.49 ± .56
24hrs post coronary angiography0.67 ± 0.660.67 ± 0.89
48hrs post coronary angiography0.68 ± 0.660.89 ± 0.84
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Patients With Major Adverse Cardiovascular and Cerebrovascular Event
ParticipantsRIPC GroupSham-RIPC Group
Number of Patients With Major Adverse Cardiovascular and Cerebrovascular Event920
SecondaryNumber 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.
Reported as:
Count of participants · Participants
Number of Patients With Major Adverse Kidney Event
ParticipantsRIPC GroupSham-RIPC Group
Number of Patients With Major Adverse Kidney Event46
SecondaryCyclic 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
Reported as:
Mean · nM
Cyclic Guanylate Monophosphate (cGMP) Level
nMRIPC GroupSham-RIPC Group
Baseline60.12 ± 84.7155.19 ± 147.46
Post RIPC68.28 ± 112.5659.66 ± 181.04
24 Hours post coronary angiogram62.91 ± 89.3655.22 ± 116.02
48 Hours post coronary angiogram65.61 ± 96.0145.04 ± 65.00

Adverse events

Collected over Up to 6 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
RIPC Group4/54 (7.4%)4/54 (7.4%)5/54 (9.3%)
Sham-RIPC Group4/55 (7.3%)8/55 (14.5%)14/55 (25.5%)
Most frequent serious events
Most frequent serious events
EventRIPC GroupSham-RIPC Group
Repeat Coronary RevascularizationCardiac disorders4/546/55
StrokeNervous system disorders0/542/55
Most frequent other events
Most frequent other events
EventRIPC GroupSham-RIPC Group
Major adverse cardiovascular and cerebrovascular eventsCardiac disorders5/5414/55
Major Adverse Kidney EventsRenal and urinary disorders4/546/55

Baseline characteristics

Predominantly elderly patients with unstable angina and non-ST elevation myocardial infarction undergoing coronary angiography with high modified Mehran risk score for acute kidney injury were enrolled in this trial.

Age, Continuous
Age, Continuous(years)RIPC GroupSham-RIPC GroupTotal
Median76 (71 to 82)75 (71 to 80)75 (71 to 81)
Sex: Female, Male
Sex: Female, Male(Participants)RIPC GroupSham-RIPC GroupTotal
Female9817
Male454792
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)RIPC GroupSham-RIPC GroupTotal
Hispanic or Latino000
Not Hispanic or Latino5455109
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)RIPC GroupSham-RIPC GroupTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American448
White5051101
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)RIPC GroupSham-RIPC GroupTotal
United States5455109
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Study locations

2 sites
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania 15213, United States
  • VA Pittsburgh Healthcare System
    Pittsburgh, Pennsylvania 15213, United States
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References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 26, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03236441
Lead sponsor
Oladipupo Olafiranye, MD, MS
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Oladipupo Olafiranye, MD, MS (Associate Professor of Medicine, University of Pittsburgh) — Sponsor-investigator
First posted
Aug 2, 2017
Start date
Mar 6, 2018
Primary completion
Feb 28, 2023
Completion
Feb 28, 2024
Results posted
Jan 9, 2025
Last update
Jan 9, 2025

Study contacts

Oladipupo Olafiranye, MD
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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