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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DK113486-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RIPC | Device | Remote ischemic preconditioning |
| |
| Sham-RIPC |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oladipupo Olafiranye, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States | ||
| VA Pittsburgh Healthcare System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40850057 | Derived | 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. |
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Out of 110 patients enrolled in this study, 1 patient withdrew after signing informed consent and prior to randomization. As a result, a total of 109 patients were randomized or assigned to RIPC or Sham-RIPC groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | RIPC Group | 3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes RIPC: Remote ischemic preconditioning |
| FG001 | 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) Sham-RIPC: Control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | RIPC Group | 3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes RIPC: Remote ischemic preconditioning |
| BG001 | Sham-RIPC Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 54 patients in the RIPC group and 55 patients in the sham-RIPC group were included in the primary outcome analysis. | Posted | Count of Participants | Participants | 24-48 hours post coronary angiography |
|
Up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RIPC Group | 3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes RIPC: Remote ischemic preconditioning |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Repeat Coronary Revascularization | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major adverse cardiovascular and cerebrovascular events | Cardiac disorders | Systematic Assessment |
The population studied was predominantly elderly male patients with non-ST elevation myocardial infarction or unstable angina.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Oladipupo Olafiranye, MD, MS | UT Southwestern Medical Center | 2148572923 | oladipupo.olafiranye@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 26, 2019 | Oct 30, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Device |
Control |
|
| 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. | 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. | 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). | 0-48 Hrs |
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
3 cycles of blood pressure cuff inflations to non-occlusive pressure of 10 mmHg for 5 minutes and deflation for 5 minutes (Control)
Sham-RIPC: Control
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
3 cycles of blood pressure cuff inflations to non-occlusive pressure of 10 mmHg for 5 minutes and deflation for 5 minutes (Control)
Sham-RIPC: Control
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | (ng/ml)2/1000 | 0-48hrs |
|
|
|
| Secondary | 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. | Patients with unstable angina and non-ST segment elevation myocardial infarction at high risk for acute kidney injury referred for coronary angiography and or percutaneous coronary angiography. | Posted | Count of Participants | Participants | 6 months post coronary angiography |
|
|
|
| Secondary | Number of Patients With Major Adverse Kidney Event | Composite outcome including persistent renal impairment, use of renal replacement therapy, and all-cause death. | Patients with unstable angina and non-ST segment elevation myocardial infarction at high risk for acute kidney injury referred for coronary angiography and or percutaneous coronary angiography. | Posted | Count of Participants | Participants | 6 months post coronary angiography. |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | nM | 0-48 Hrs |
|
|
|
| 4 |
| 54 |
| 4 |
| 54 |
| 5 |
| 54 |
| EG001 | 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) Sham-RIPC: Control | 4 | 55 | 8 | 55 | 14 | 55 |
| Stroke | Nervous system disorders | Systematic Assessment |
|
| Major Adverse Kidney Events | Renal and urinary disorders | Systematic Assessment |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| 24hrs post coronary angiography |
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| 48hrs post coronary angiography |
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| 24 Hours post coronary angiogram |
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| 48 Hours post coronary angiogram |
|