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Trial record 31 of 49 for:    Recruiting, Not yet recruiting, Available Studies | kidney disease | NIDDK

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

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ClinicalTrials.gov Identifier: NCT03236441
Recruitment Status : Recruiting
First Posted : August 2, 2017
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Oladipupo Olafiranye, MD, MS, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Contrast-induced Acute Kidney Injury Device: RIPC Device: Sham-RIPC Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Biochemical and Reno-protective Effects of Remote Ischemic Pre-conditioning on Contrast-induced Acute Kidney Injury
Actual Study Start Date : March 5, 2018
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 2020

Arm Intervention/treatment
Active Comparator: RIPC Group
3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes
Device: RIPC
Remote ischemic preconditioning

Sham Comparator: 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)
Device: Sham-RIPC
Control




Primary Outcome Measures :
  1. Contrast-induced acute kidney injury [ Time Frame: 48 hours ]
    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 :
  1. Biomarkers study [ Time Frame: 0-48 hours ]
    Novel vascular and renal biomarkers



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03236441


Contacts
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Contact: Amanda Bollino, RN 412-647-8210 bollinoae@upmc.edu
Contact: Linda Spearman 412-647-7976 spearmanln@upmc.edu

Locations
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United States, Pennsylvania
The University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Amanda Bollino, RN    412-647-8210    bollinoae@upmc.edu   
VA Pittsburgh Healthcare System Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Oladipupo Olafiranye, MD    412-802-3131    olafiranyeo@upmc.edu   
Sponsors and Collaborators
Oladipupo Olafiranye, MD, MS
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Oladipupo Olafiranye, MD University of Pittsburgh

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Responsible Party: Oladipupo Olafiranye, MD, MS, Assistant Professor of Medicine and Emergency Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03236441     History of Changes
Other Study ID Numbers: PRO17070546
1R21DK113486-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Oladipupo Olafiranye, MD, MS, University of Pittsburgh:
remote ischemic conditioning
contrast-induced nephropathy
cardiac catheterization
coronary artery disease
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases