<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/NCT03233919</url>
  </required_header>
  <id_info>
    <org_study_id>2017-866</org_study_id>
    <nct_id>NCT03233919</nct_id>
  </id_info>
  <brief_title>COmprehensive Remote Ischemic Conditioning in Myocardial Infarction</brief_title>
  <acronym>CORIC-MI</acronym>
  <official_title>Evaluation of Comprehensive Remote Ischemic Conditioning in ST-elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China National Center for Cardiovascular Diseases</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China National Center for Cardiovascular Diseases</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the CORIC-MI trial is to evaluate whether comprehensive (per, post&#xD;
      plus delayed) remote ischemic conditioning (CORIC) as an adjunctive therapy in patients with&#xD;
      ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary&#xD;
      intervention (PPCI) can improve left ventricular function and remodeling at 30 days assessed&#xD;
      by cardiac magnetic resonance imaging (CMR) for a minimum follow-up period of 12 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ST-segment elevation myocardial infarction (STEMI) is a leading cause of mortality and&#xD;
      morbidity worldwide. Rapid admission and acute interventional treatment combined with modern&#xD;
      antithrombotic pharmacologic therapy frequently establish complete reperfusion and acutely&#xD;
      stabilize the patient, but the reperfusion itself adds further to the damage in the&#xD;
      myocardium compromising the long-term outcome. At present, remote ischemic conditioning (RIC)&#xD;
      is the most promising adjuvant therapy to reduce reperfusion injury in patients with STEMI.&#xD;
      However, myocardial remodeling continues for several weeks after a myocardial infarction.&#xD;
      Recent animal studies have shown that RIC may also help the heart muscle recover if applied&#xD;
      every day during the month after a heart attack.&#xD;
&#xD;
      The CORIC-MI trial is a single-center, randomized, controlled, parallel group, and open-label&#xD;
      trial, with blinded evaluation of the endpoints.The primary objective of the trial is to&#xD;
      evaluate whether comprehensive (per, post plus delayed) remote ischemic conditioning (CORIC)&#xD;
      as an adjunctive therapy in patients with STEMI undergoing primary percutaneous coronary&#xD;
      intervention (PPCI) can improve left ventricular function and remodeling at 30 days assessed&#xD;
      by cardiac magnetic resonance imaging (CMR) for a minimum follow-up period of 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">January 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 30, 2019</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>left ventricular ejection fraction (LVEF) assessed by CMR</measure>
    <time_frame>at 30 days after MI</time_frame>
    <description>LVEF assessed by CMR at 30 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Infarct size assessed by CMR.</measure>
    <time_frame>at 30 days after MI</time_frame>
    <description>Infarct size assessed by CMR delayed enhancement volume at 30 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LVEDVi and LVESVi assessed by CMR.</measure>
    <time_frame>at 30 days after MI</time_frame>
    <description>LVEDVi and LVESVi assessed by cMRI at 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LVEF assessed by echocardiography.</measure>
    <time_frame>at 30 days, 180 days and 365 days after MI</time_frame>
    <description>LVEF assessed by echocardiography at 30 days, 180 days and 365 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LVEDVi assessed by echocardiography.</measure>
    <time_frame>at 30 days, 180 days and 365 days after MI.</time_frame>
    <description>LVEDVi assessed by echocardiography at 30 days, 180 days and 365 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in LVEDVi assessed by echocardiography.</measure>
    <time_frame>at 30 days, 180 days and 365 days after MI.</time_frame>
    <description>The change in LVEDVi assessed by echocardiography from baseline to 30 days, 180 days or 365 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MACE including death, re-infarction, rehospitalization for heart failure, and ischemic stroke</measure>
    <time_frame>at 30 days, 180 days and 365 days after MI.</time_frame>
    <description>MACE including death, re-infarction, rehospitalization for heart failure, and ischemic stroke at 30 days, 180 days and 365 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean blood N terminal (NT)-PROBNP levels</measure>
    <time_frame>at 30 days, 180 days and 365 days</time_frame>
    <description>Mean blood NT-PROBNP levels at 30 days, 180 days and 365 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TIMI flow and frame count</measure>
    <time_frame>at the last angiogram during PPCI</time_frame>
    <description>TIMI flow and frame count are evaluated at the last angiogram during PPCI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ST-segment resolution</measure>
    <time_frame>on 90 min ECG after reperfusion</time_frame>
    <description>ST-segment resolution on 90 min ECG after reperfusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the 6-min walk test distance</measure>
    <time_frame>at 30 days and 180 days after MI</time_frame>
    <description>the 6-min walk test distance at 30 days and 180 days after MI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Self-rating Anxiety Scale (SAS) score</measure>
    <time_frame>at 30 days and 180 days after MI</time_frame>
    <description>Mean SAS score at 30 days and 180 days after MI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Self-rating Depression Scale (SDS) score</measure>
    <time_frame>at 30 days and 180 days after MI.</time_frame>
    <description>Mean SDS score at 30 days and 180 days after MI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean score of health-related quality of life by using Short-Form 36 Health Survey (SF-36).</measure>
    <time_frame>at 30 days and 180 days after MI.</time_frame>
    <description>The mean score of health-related quality of life by using SF-36 at 30 days and 180 days after MI.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Contrast-induced nephropathy</measure>
    <time_frame>at 72 hour and 30 days post-PPCI</time_frame>
    <description>Contrast-induced nephropathy at 72 hour and 30 days post-PPCI</description>
  </other_outcome>
  <other_outcome>
    <measure>Platelet reactivity</measure>
    <time_frame>at baseline, 6 hours post-loading dose of antiplatelet, 7 days, 30 days and 180 days after MI.</time_frame>
    <description>Platelet reactivity assessed by VerifyNow P2Y12 assay at baseline, 6 hours post-loading dose of antiplatelet, 7 days, 30 days and 180 days after MI.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Myocardial Infarction, Anterior Wall</condition>
  <arm_group>
    <arm_group_label>CORIC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Comprehensive remote ischaemic conditioning (CORIC) will be induced using an automated RIC device:&#xD;
Per-RIC consists of 5 cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on a lower limb. The first inflation began immediately following randomization after admission. In case 5 cycles of RIC were not fully completed when the first balloon inflation or thrombus aspiration was ready to be performed, PCI was not to be delayed.&#xD;
Post-RIC consists of 5 cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on a lower limb immediately after PPCI.&#xD;
Delayed-RIC consists of 5 cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on a lower limb once daily on 2-28 days after MI.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-CORIC</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Controls did not undergo comprehensive remote ischaemic conditioning.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>comprehensive remote ischaemic conditioning</intervention_name>
    <description>comprehensive remote ischaemic conditioning will be induced using an automated RIC device: Per-RIC consists of 5 cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on a lower limb. The first inflation began immediately following randomization after admission. In case 5 cycles of RIC were not fully completed when the first balloon inflation or thrombus aspiration was ready to be performed, PCI was not to be delayed.&#xD;
Post-RIC consists of 5 cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on a lower limb immediately after PPCI.&#xD;
Delayed-RIC consists of 5 cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on a lower limb once daily on 2-28 days after MI.</description>
    <arm_group_label>CORIC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suspected anterior STEMI: new ST-elevation &gt; 0.1 millivolt (mV) (≥ 0.2 mV in men or ≥&#xD;
             0.15 mV in women in leads V2-V3) in &gt; two contiguous leads in V1-V6; new or presumed&#xD;
             new left bundle branch block;&#xD;
&#xD;
          -  Symptom onset no more than 12 h before presentation and planned primary PCI;&#xD;
&#xD;
          -  Age 18 to 75 years;&#xD;
&#xD;
          -  Willingness and capability to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous anterior myocardial infarction;&#xD;
&#xD;
          -  Previous coronary artery bypass graft (CABG);&#xD;
&#xD;
          -  Myocardial infarction or stroke within the previous 30 days;&#xD;
&#xD;
          -  Treatment with thrombolysis within the previous 30 days;&#xD;
&#xD;
          -  Cardiogenic shock;&#xD;
&#xD;
          -  Thrombolysis in myocardial infarction (TIMI) flow grade 2 or 3 at coronary&#xD;
             angiography;&#xD;
&#xD;
          -  Coronary anatomy or mechanical complication of STEMI (ventricular septal rupture, free&#xD;
             wall rupture, acute severe mitral regurgitation) warranting emergent surgery;&#xD;
&#xD;
          -  Inability to obtain TIMI flow grade ≥ 2;&#xD;
&#xD;
          -  Conditions precluding use of RIC (paresis of lower limb, known severe peripheral&#xD;
             artery disease or evidence of lower limb ischemia, and etc.);&#xD;
&#xD;
          -  Life expectancy of less than 12 months due to non-cardiac disease such as known&#xD;
             malignancy or other comorbid conditions;&#xD;
&#xD;
          -  Contraindications to CMR;&#xD;
&#xD;
          -  Treated with therapeutic hypothermia before admission;&#xD;
&#xD;
          -  Pregnancy and lactating women;&#xD;
&#xD;
          -  Participation in another interventional trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>hongbing Yan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Center for Cardiovascular Diseases</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chinese Academy of Medical Sciences, Fuwai Hospital</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Center for Cardiovascular Diseases</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>hongbing yan, MD</last_name>
    <phone>0086+010 88322281</phone>
    <email>bcc_ami@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Li Song, MD</last_name>
    <phone>0086+010 88322287</phone>
    <email>sl9919@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Chinese Academy of Medical Sciences, Fuwai Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100037</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hongbing Yan, MD</last_name>
      <phone>(0086)10+88322281</phone>
      <email>bcc_ami@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Li Song, MD</last_name>
      <phone>(0086)10+88322287</phone>
      <email>sl9919@126.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>April 20, 2018</last_update_submitted>
  <last_update_submitted_qc>April 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese Academy of Medical Sciences, Fuwai Hospital</investigator_affiliation>
    <investigator_full_name>hongbing_yan</investigator_full_name>
    <investigator_title>Co-Director, Center of cronary artery disease, Fuwai hospital</investigator_title>
  </responsible_party>
  <keyword>Remote Ischemic Conditioning</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Anterior Wall Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03233919
org study id: 2017-866
nct id: NCT03233919
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary objective of the CORIC-MI trial is to evaluate whether comprehensive (per, post
      plus delayed) remote ischemic conditioning (CORIC) as an adjunctive therapy in patients with
      ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary
      intervention (PPCI) can improve left ventricular function and remodeling at 30 days assessed
      by cardiac magnetic resonance imaging (CMR) for a minimum follow-up period of 12 months.
ST-segment elevation myocardial infarction (STEMI) is a leading cause of mortality and
      morbidity worldwide. Rapid admission and acute interventional treatment combined with modern
      antithrombotic pharmacologic therapy frequently establish complete reperfusion and acutely
      stabilize the patient, but the reperfusion itself adds further to the damage in the
      myocardium compromising the long-term outcome. At present, remote ischemic conditioning (RIC)
      is the most promising adjuvant therapy to reduce reperfusion injury in patients with STEMI.
      However, myocardial remodeling continues for several weeks after a myocardial infarction.
      Recent animal studies have shown that RIC may also help the heart muscle recover if applied
      every day during the month after a heart attack.

      The CORIC-MI trial is a single-center, randomized, controlled, parallel group, and open-label
      trial, with blinded evaluation of the endpoints.The primary objective of the trial is to
      evaluate whether comprehensive (per, post plus delayed) remote ischemic conditioning (CORIC)
      as an adjunctive therapy in patients with STEMI undergoing primary percutaneous coronary
      intervention (PPCI) can improve left ventricular function and remodeling at 30 days assessed
      by cardiac magnetic resonance imaging (CMR) for a minimum follow-up period of 12 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: left ventricular ejection fraction (LVEF) assessed by CMR
time frame: at 30 days after MI
description: LVEF assessed by CMR at 30 days
measure: Infarct size assessed by CMR.
time frame: at 30 days after MI
description: Infarct size assessed by CMR delayed enhancement volume at 30 days.
measure: LVEDVi and LVESVi assessed by CMR.
time frame: at 30 days after MI
description: LVEDVi and LVESVi assessed by cMRI at 30 days
measure: LVEF assessed by echocardiography.
time frame: at 30 days, 180 days and 365 days after MI
description: LVEF assessed by echocardiography at 30 days, 180 days and 365 days.
measure: LVEDVi assessed by echocardiography.
time frame: at 30 days, 180 days and 365 days after MI.
description: LVEDVi assessed by echocardiography at 30 days, 180 days and 365 days.
measure: The change in LVEDVi assessed by echocardiography.
time frame: at 30 days, 180 days and 365 days after MI.
description: The change in LVEDVi assessed by echocardiography from baseline to 30 days, 180 days or 365 days.
measure: MACE including death, re-infarction, rehospitalization for heart failure, and ischemic stroke
time frame: at 30 days, 180 days and 365 days after MI.
description: MACE including death, re-infarction, rehospitalization for heart failure, and ischemic stroke at 30 days, 180 days and 365 days.
measure: Mean blood N terminal (NT)-PROBNP levels
time frame: at 30 days, 180 days and 365 days
description: Mean blood NT-PROBNP levels at 30 days, 180 days and 365 days.
measure: TIMI flow and frame count
time frame: at the last angiogram during PPCI
description: TIMI flow and frame count are evaluated at the last angiogram during PPCI.
measure: ST-segment resolution
time frame: on 90 min ECG after reperfusion
description: ST-segment resolution on 90 min ECG after reperfusion
measure: the 6-min walk test distance
time frame: at 30 days and 180 days after MI
description: the 6-min walk test distance at 30 days and 180 days after MI.
measure: Mean Self-rating Anxiety Scale (SAS) score
time frame: at 30 days and 180 days after MI
description: Mean SAS score at 30 days and 180 days after MI.
measure: Mean Self-rating Depression Scale (SDS) score
time frame: at 30 days and 180 days after MI.
description: Mean SDS score at 30 days and 180 days after MI.
measure: Mean score of health-related quality of life by using Short-Form 36 Health Survey (SF-36).
time frame: at 30 days and 180 days after MI.
description: The mean score of health-related quality of life by using SF-36 at 30 days and 180 days after MI.
measure: Contrast-induced nephropathy
time frame: at 72 hour and 30 days post-PPCI
description: Contrast-induced nephropathy at 72 hour and 30 days post-PPCI
measure: Platelet reactivity
time frame: at baseline, 6 hours post-loading dose of antiplatelet, 7 days, 30 days and 180 days after MI.
description: Platelet reactivity assessed by VerifyNow P2Y12 assay at baseline, 6 hours post-loading dose of antiplatelet, 7 days, 30 days and 180 days after MI.
arm group label: CORIC
arm group type: Experimental
description: Comprehensive remote ischaemic conditioning (CORIC) will be induced using an automated RIC device:
Per-RIC consists of 5 cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on a lower limb. The first inflation began immediately following randomization after admission. In case 5 cycles of RIC were not fully completed when the first balloon inflation or thrombus aspiration was ready to be performed, PCI was not to be delayed.
Post-RIC consists of 5 cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on a lower limb immediately after PPCI.
Delayed-RIC consists of 5 cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on a lower limb once daily on 2-28 days after MI.
arm group label: Non-CORIC
arm group type: No Intervention
description: Controls did not undergo comprehensive remote ischaemic conditioning.
intervention type: Device
intervention name: comprehensive remote ischaemic conditioning
description: comprehensive remote ischaemic conditioning will be induced using an automated RIC device: Per-RIC consists of 5 cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on a lower limb. The first inflation began immediately following randomization after admission. In case 5 cycles of RIC were not fully completed when the first balloon inflation or thrombus aspiration was ready to be performed, PCI was not to be delayed.
Post-RIC consists of 5 cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on a lower limb immediately after PPCI.
Delayed-RIC consists of 5 cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on a lower limb once daily on 2-28 days after MI.
arm group label: CORIC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: hongbing Yan, MD
role: Principal Investigator
affiliation: National Center for Cardiovascular Diseases
last name: Chinese Academy of Medical Sciences, Fuwai Hospital
role: Principal Investigator
affiliation: National Center for Cardiovascular Diseases
last name: hongbing yan, MD
phone: 0086+010 88322281
email: bcc_ami@126.com
last name: Li Song, MD
phone: 0086+010 88322287
email: sl9919@126.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
investigator full name: hongbing_yan
investigator title: Co-Director, Center of cronary artery disease, Fuwai hospital
mesh term: Myocardial Infarction
mesh term: Anterior Wall Myocardial Infarction
mesh term: Infarction
sharing ipd: No