Clinical trial NCT03236441: Biochemical Effects of Remote Ischemic Pre-Conditioning on Contrast-induced Acute Kidney Injury
Official title: Biochemical and Reno-protective Effects of Remote Ischemic Pre-conditioning on Contrast-induced Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contrast-induced Acute Kidney Injury
Keywords: remote ischemic conditioning
contrast-induced nephropathy
cardiac catheterization
coronary artery disease
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-08-02
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Number of Patients With Acute Kidney Injury
timeFrame: 24-48 hours post coronary angiography
Secondary outcomes:
measure: The Product of Urinary (Tissue Inhibitor of Metalloproteinases 2) X (Insulin-like Growth Factor-binding Protein 7)
timeFrame: 0-48hrs
measure: Number of Patients With Major Adverse Cardiovascular and Cerebrovascular Event
timeFrame: 6 months post coronary angiography
measure: Number of Patients With Major Adverse Kidney Event
timeFrame: 6 months post coronary angiography.
measure: Cyclic Guanylate Monophosphate (cGMP) Level
timeFrame: 0-48 Hrs
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Oladipupo Olafiranye, MD
role: PRINCIPAL_INVESTIGATOR
References: