Biochemical Effects of Remote Ischemic Pre-Conditioning on Contrast-induced Acute Kidney Injury
- Conditions
- Contrast-induced Acute Kidney Injury
- Interventions
- Device: RIPCDevice: Sham-RIPC
- Registration Number
- NCT03236441
- Lead Sponsor
- Oladipupo Olafiranye, MD, MS
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RIPC Group RIPC 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-RIPC 3 cycles of blood pressure cuff inflations to non-occlusive pressure of 10 mmHg for 5 minutes and deflation for 5 minutes (Control)
- Primary Outcome Measures
Name Time Method Number of Patients With Acute Kidney Injury 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 Outcome Measures
Name Time Method The Product of Urinary (Tissue Inhibitor of Metalloproteinases 2) X (Insulin-like Growth Factor-binding Protein 7) 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.
Number of Patients With Major Adverse Cardiovascular and Cerebrovascular Event 6 months post coronary angiography Composite outcome including rehospitalization for myocardial infarction, hospitalization for heart failure, repeat revascularization, stroke, and cardiac death.
Number of Patients With Major Adverse Kidney Event 6 months post coronary angiography. Composite outcome including persistent renal impairment, use of renal replacement therapy, and all-cause death.
Cyclic Guanylate Monophosphate (cGMP) Level 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).
Trial Locations
- Locations (2)
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
VA Pittsburgh Healthcare System
🇺🇸Pittsburgh, Pennsylvania, United States