Contrast-induced Acute Kidney InjuryBRICKNCT03236441
Biochemical Effects of Remote Ischemic Pre-Conditioning on Contrast-induced Acute Kidney Injury
A study testing RIPC in people with Contrast-induced Acute Kidney Injury, run by Oladipupo Olafiranye, MD, MS at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast-induced Acute Kidney Injury
- What is being tested?
- RIPC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Mar 2018to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Biochemical and Reno-protective 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.
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.
- Conditions
- Contrast-induced Acute Kidney Injury
- Being tested
- RIPC, Sham-RIPC
- Keywords
- remote ischemic conditioning, contrast-induced nephropathy, cardiac catheterization, coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIPCDevice
Remote ischemic preconditioning
Sham-RIPCDevice
Control
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Device: Sham-RIPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 0-48 Hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start6 Mar 2018
- Primary completion28 Feb 2023
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contrast-induced Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oladipupo Olafiranye, MD, MS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Oladipupo Olafiranye, MD, MS, University of Pittsburgh
- Investigators
- Oladipupo Olafiranye, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236441
- Sponsor's protocol ID
- STUDY19090247
- Other IDs
- 1R21DK113486-01A1
- Acronym
- BRICK
- Status last verified
- Jan 2025
- First submitted
- 27 Jul 2017
- Last updated
- 9 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 40850057
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biochemical and Reno-protective Effects of Remote Ischemic Pre-conditioning on Contrast-induced Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT03236441
- Acronym / sponsor ID
- BRICK / STUDY19090247
- Conditions
- Contrast-induced Acute Kidney Injury
- Keywords
- remote ischemic conditioning, contrast-induced nephropathy, cardiac catheterization, coronary artery disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Oladipupo Olafiranye, MD, MSUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 2 Aug 2017 (actual)
- Results
- Posted 9 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIPC Group | Active comparator | Device: RIPC3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes |
| Sham-RIPC Group | Sham comparator | Device: Sham-RIPC3 cycles of blood pressure cuff inflations to non-occlusive pressure of 10 mmHg for 5 minutes and deflation for 5 minutes (Control) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RIPCRemote ischemic preconditioning | Device | RIPC Group |
| Sham-RIPCControl | Device | Sham-RIPC Group |
Primary outcome
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.
4 secondary outcomes
The Product of Urinary (Tissue Inhibitor of Metalloproteinases 2) X (Insulin-like Growth Factor-binding Protein 7)
Time frame: 0-48hrs
Number of Patients With Major Adverse Cardiovascular and Cerebrovascular Event
Time frame: 6 months post coronary angiography
Number of Patients With Major Adverse Kidney Event
Time frame: 6 months post coronary angiography.
Cyclic Guanylate Monophosphate (cGMP) Level
Time frame: 0-48 Hrs
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40850057Olafiranye 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.
- Individual participant dataSharing planned: No
Related trials for Contrast-induced Acute Kidney Injury
Recruiting
Effectiveness of Remote Ischemic Preconditioning for Prevention of Contrast Induced Acute Kidney Injury in Patients Undergoing Coronary Angiograms.
Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI), Contrast-induced Nephropathy Following Coronary Angiogram (CIN)
Not yet recruitingObservational study
Uric Acid to Albumin Ratio for Predicting Contrast Associated Acute Kidney Injury After Cardiac and Non Cardiac Procedures
Contrast-Induced Nephropathy, Acute Kidney Injury
Not yet recruitingObservational study
An Observational Study of Percutaneous Glomerular Filtration Rate (TGFR) in the Early Warning of Contrast-induced Acute Kidney Injury During the Peri-examination Period of Emergency Enhanced CT
Contrast-associated Acute Kidney Injury
Not yet recruitingObservational study
Beyond the Mehran Risk Score: Predictive Value of Total Ischemic Time for Contrast-Induced Nephropathy in ST Segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention.
ST Elevation (STEMI) Myocardial Infarction, Contrast Induced Nephropathy (CIN)
Not yet recruitingObservational study
Contrast Volume as a Predictor of Kidney Injury Following Contrast-Enhanced CT
Contrast-Associated Acute Kidney Injury, Acute Kidney Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oladipupo Olafiranye, MD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIPC in people with Contrast-induced Acute Kidney Injury, run by Oladipupo Olafiranye, MD, MS at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Acute Kidney Injury (time frame: 24-48 hours post coronary angiography). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03236441, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.