Biochemical Effects of Remote Ischemic Pre-Conditioning on Contrast-induced Acute Kidney Injury (BRICK)
Primary Purpose
Contrast-induced Acute Kidney Injury
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RIPC
Sham-RIPC
Sponsored by
About this trial
This is an interventional treatment trial for Contrast-induced Acute Kidney Injury focused on measuring remote ischemic conditioning, contrast-induced nephropathy, cardiac catheterization, coronary artery disease
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
Sites / Locations
- University of Pittsburgh Medical Center
- VA Pittsburgh Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
RIPC Group
Sham-RIPC Group
Arm Description
3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes
3 cycles of blood pressure cuff inflations to non-occlusive pressure of 10 mmHg for 5 minutes and deflation for 5 minutes (Control)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Biomarkers study
Novel vascular and renal biomarkers
Major Adverse Cardiovascular Event
Major Adverse Kidney Event
Full Information
NCT ID
NCT03236441
First Posted
July 27, 2017
Last Updated
August 24, 2023
Sponsor
Oladipupo Olafiranye, MD, MS
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT03236441
Brief Title
Biochemical Effects of Remote Ischemic Pre-Conditioning on Contrast-induced Acute Kidney Injury
Acronym
BRICK
Official Title
Biochemical and Reno-protective Effects of Remote Ischemic Pre-conditioning on Contrast-induced Acute Kidney Injury
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 6, 2018 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Oladipupo Olafiranye, MD, MS
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast-induced Acute Kidney Injury
Keywords
remote ischemic conditioning, contrast-induced nephropathy, cardiac catheterization, coronary artery disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RIPC Group
Arm Type
Active Comparator
Arm Description
3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes
Arm Title
Sham-RIPC Group
Arm Type
Sham Comparator
Arm Description
3 cycles of blood pressure cuff inflations to non-occlusive pressure of 10 mmHg for 5 minutes and deflation for 5 minutes (Control)
Intervention Type
Device
Intervention Name(s)
RIPC
Intervention Description
Remote ischemic preconditioning
Intervention Type
Device
Intervention Name(s)
Sham-RIPC
Intervention Description
Control
Primary Outcome Measure Information:
Title
Contrast-induced acute kidney injury
Description
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.
Time Frame
24-48 hours
Secondary Outcome Measure Information:
Title
Biomarkers study
Description
Novel vascular and renal biomarkers
Time Frame
0-48 hours
Title
Major Adverse Cardiovascular Event
Time Frame
1 month and 6 months
Title
Major Adverse Kidney Event
Time Frame
1 month and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oladipupo Olafiranye, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
VA Pittsburgh Healthcare System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Biochemical Effects of Remote Ischemic Pre-Conditioning on Contrast-induced Acute Kidney Injury
We'll reach out to this number within 24 hrs