<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03236441</url>
  </required_header>
  <id_info>
    <org_study_id>PRO17070546</org_study_id>
    <secondary_id>1R21DK113486-01A1</secondary_id>
    <nct_id>NCT03236441</nct_id>
  </id_info>
  <brief_title>Biochemical Effects of Remote Ischemic Pre-Conditioning on Contrast-induced Acute Kidney Injury</brief_title>
  <acronym>BRICK</acronym>
  <official_title>Biochemical and Reno-protective Effects of Remote Ischemic Pre-conditioning on Contrast-induced Acute Kidney Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oladipupo Olafiranye, MD, MS</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This a prospective, double-blind, sham-controlled, randomized clinical trial to study the&#xD;
      effects of remote ischemic preconditioning on contrast-induced acute kidney injury, vascular&#xD;
      and renal biomarkers in patients with non-ST elevation myocardial infarction and unstable&#xD;
      angina undergoing cardiac catheterization and percutaneous coronary intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The BRICK study is a prospective, double-blind, sham-controlled, randomized clinical trial in&#xD;
      patients with non-ST elevation myocardial infarction and unstable angina undergoing cardiac&#xD;
      catheterization and percutaneous coronary intervention who are at high risk for&#xD;
      contrast-induced acute kidney injury. The study will investigate the effects of remote&#xD;
      ischemic preconditioning before cardiac catheterization on rate of contrast induced acute&#xD;
      kidney injury and novel biomarkers of renal injury/protection within 48hrs of cardiac&#xD;
      catheterization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 6, 2018</start_date>
  <completion_date type="Anticipated">February 28, 2024</completion_date>
  <primary_completion_date type="Actual">February 28, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Contrast-induced acute kidney injury</measure>
    <time_frame>24-48 hours</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biomarkers study</measure>
    <time_frame>0-48 hours</time_frame>
    <description>Novel vascular and renal biomarkers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Cardiovascular Event</measure>
    <time_frame>1 month and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Kidney Event</measure>
    <time_frame>1 month and 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Contrast-induced Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>RIPC Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham-RIPC Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>3 cycles of blood pressure cuff inflations to non-occlusive pressure of 10 mmHg for 5 minutes and deflation for 5 minutes (Control)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RIPC</intervention_name>
    <description>Remote ischemic preconditioning</description>
    <arm_group_label>RIPC Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham-RIPC</intervention_name>
    <description>Control</description>
    <arm_group_label>Sham-RIPC Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with non-ST elevation myocardial infarction or unstable angina&#xD;
&#xD;
          -  Referral for cardiac catheterization and percutaneous coronary intervention&#xD;
&#xD;
          -  Contrast-induced acute kidney injury risk score of ≥11&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  unstable blood pressure (systolic blood pressure &gt; 200 or &lt;90 mmHg)&#xD;
&#xD;
          -  History of allergy to contrast media&#xD;
&#xD;
          -  Peripheral vascular disease of upper limb&#xD;
&#xD;
          -  Renal disease requiring dialysis&#xD;
&#xD;
          -  Placement of arteriovenous fistula and arteriovenous graft&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Oladipupo Olafiranye, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Pittsburgh Healthcare System</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>August 24, 2023</last_update_submitted>
  <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Oladipupo Olafiranye, MD, MS</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine and Emergency Medicine</investigator_title>
  </responsible_party>
  <keyword>remote ischemic conditioning</keyword>
  <keyword>contrast-induced nephropathy</keyword>
  <keyword>cardiac catheterization</keyword>
  <keyword>coronary artery disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03236441
org study id: PRO17070546
secondary id: 1R21DK113486-01A1
nct id: NCT03236441
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Contrast-induced acute kidney injury
time frame: 24-48 hours
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.
measure: Biomarkers study
time frame: 0-48 hours
description: Novel vascular and renal biomarkers
measure: Major Adverse Cardiovascular Event
time frame: 1 month and 6 months
measure: Major Adverse Kidney Event
time frame: 1 month and 6 months
arm group label: RIPC Group
arm group type: Active Comparator
description: 3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes
arm group label: Sham-RIPC Group
arm group type: Sham Comparator
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: RIPC
description: Remote ischemic preconditioning
arm group label: RIPC Group
intervention type: Device
intervention name: Sham-RIPC
description: Control
arm group label: Sham-RIPC Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Oladipupo Olafiranye, MD
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Oladipupo Olafiranye, MD, MS
investigator title: Assistant Professor of Medicine and Emergency Medicine
mesh term: Acute Kidney Injury
mesh term: Wounds and Injuries
sharing ipd: Undecided