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

Contrast-induced Acute Kidney Injury Clinical Trial

— BRICK  

Official title:

Biochemical and Reno-protective Effects of Remote Ischemic Pre-conditioning on Contrast-induced Acute Kidney Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03236441
• Other study ID #: PRO17070546
• Secondary ID: 1R21DK113486-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 6, 2018
• Est. completion date: February 28, 2024

Study information

• Verified date: August 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This a prospective, double-blind, sham-controlled, randomized clinical trial to study the effects of remote ischemic preconditioning on contrast-induced acute kidney injury, vascular and renal biomarkers in patients with non-ST elevation myocardial infarction and unstable angina undergoing cardiac catheterization and percutaneous coronary intervention.

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 cardiac catheterization and percutaneous coronary intervention who are at high risk for contrast-induced acute kidney injury. The study will investigate the effects of remote ischemic preconditioning before cardiac catheterization on rate of contrast induced acute kidney injury and novel biomarkers of renal injury/protection within 48hrs of cardiac catheterization.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Contrast-induced Acute Kidney Injury
• Wounds and Injuries

Intervention

Device:
• RIPC
Remote ischemic preconditioning
• Sham-RIPC
Control

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	VA Pittsburgh Healthcare System	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Oladipupo Olafiranye, MD, MS	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast-induced acute kidney injury	Contrast-induced acute kidney injury is defined as a relative increase in serum creatinine of = 0.3mg/dl at 48 hours post catheterization compared with initial creatinine before catheterization.	24-48 hours
Secondary	Biomarkers study	Novel vascular and renal biomarkers	0-48 hours
Secondary	Major Adverse Cardiovascular Event		1 month and 6 months
Secondary	Major Adverse Kidney Event		1 month and 6 months