<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/NCT04490785</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL20_0020</org_study_id>
    <nct_id>NCT04490785</nct_id>
  </id_info>
  <brief_title>Mri characterIzation of Troponin Elevation After Cardiac Surgery</brief_title>
  <acronym>MITEC</acronym>
  <official_title>Characterization of Postoperative Myocardial Lesions by Cardiac MRI and Anatomo-biological Correlations With Serum Troponin in Cardiac Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cardiac surgery under cardiopulmonary bypass (CPB) induces myocardial ischemia-reperfusion&#xD;
      injury. This myocardial attack is a well-identified independent prognostic factor of&#xD;
      postoperative morbidity and mortality. The quantification of these myocardial lesions by the&#xD;
      postoperative plasma release of troponin has proven its diagnostic and prognostic value.&#xD;
&#xD;
      Cardiac magnetic resonance imaging (MRI) can accurately measure and characterize the size of&#xD;
      myocardial lesions. These lesions are associated with a poor prognosis. MRI can also&#xD;
      characterize myocardial edema secondary to ischemia-reperfusion which has not yet been&#xD;
      studied in the context of CPB. It is therefore necessary, in a mechanistic approach, to&#xD;
      quantify the respective share of necrosis, edema and reperfusion lesions during cardiac&#xD;
      surgery under CPB in order to better understand these phenomena and to propose effective&#xD;
      strategies for the prevention of these myocardial lesions.the relationship between the&#xD;
      postoperative release of troponin and the amount of myocardial necrosis and edema measured by&#xD;
      cardiac MRI will be assessed.The hypothesis is to demonstrate a positive correlation between&#xD;
      imaging and biology in order to better understand the perioperative myocardial lesion&#xD;
      processes.&#xD;
&#xD;
      This is an interventional study prospective, exploratory, in cardiac imaging, non-comparative&#xD;
      and single-center, including 30 patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2, 2020</start_date>
  <completion_date type="Actual">January 12, 2023</completion_date>
  <primary_completion_date type="Actual">January 12, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>correlation between cardiac MRI and the AUC of postoperative plasma released hsTnI.</measure>
    <time_frame>5 days</time_frame>
    <description>Correlation between the AUC of plasma hsTnI levels measured during the first 72 hours postoperatively (sequential basal assays then 4, 8, 12, 24, 48 and 72 hours after aortic unclamping) and the mass in grams of myocardial necrosis measured by the late enhancement in cardiac MRI on D5 postoperative. Correlations between MRI anatomical data and biological or ultrasound data will be assessed with the Pearson or Spearman correlation coefficient according to the distribution of variables and linear regression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relationship between peak serum hsTnI and mass in grams of necrosis on MRI.</measure>
    <time_frame>5 days</time_frame>
    <description>Correlation between highest serum value recorded for each patient within 72 hours and the mass in grams of myocardial necrosis measured by the late enhancement in cardiac MRI on D5 postoperative.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC / serum peak hsTnI relationship and relative size of the necrosis on MRI</measure>
    <time_frame>5 days</time_frame>
    <description>Correlation between the AUC of plasma hsTnI levels measured during the first 72 hours postoperatively (sequential basal assays then 4, 8, 12, 24, 48 and 72 hours after aortic unclamping) and percentage of left ventricular mass. Correlation between highest serum value recorded for each patient within 72 hours and percentage of left ventricular mass.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship of hsTnI levels at 24 hours after aortic unclamping and the mass in grams of necrosis on MRI.</measure>
    <time_frame>5 days</time_frame>
    <description>Correlation between the AUC of plasma hsTnI levels measured at 24 hours after aortic unclamping and the mass in grams of myocardial necrosis measured by the late enhancement in cardiac MRI on D5 postoperative.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC / peak serum hsTnI relationship and intensity of edema</measure>
    <time_frame>5 days</time_frame>
    <description>Correlation between the AUC of plasma hsTnI levels measured during the first 72 hours postoperatively (sequential basal assays then 4, 8, 12, 24, 48 and 72 hours after aortic unclamping) and intensity of edema at MRI. Correlation between highest serum value recorded for each patient within 72 hours and intensity of edema at MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC / hsTnI serum peak relationship and the presence of microvascular obstruction lesions on MRI on postoperative D5</measure>
    <time_frame>5 days</time_frame>
    <description>Correlation between the AUC of plasma hsTnI levels measured during the first 72 hours postoperatively (sequential basal assays then 4, 8, 12, 24, 48 and 72 hours after aortic unclamping) and the presence of microvascular obstruction lesions on MRI on postoperative D5.&#xD;
Correlation between highest serum value recorded for each patient within 72 hours and the presence of microvascular obstruction lesions on MRI on postoperative D5.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relation of functional and anatomical parameters evaluated by cardiac MRI on postoperative D5.</measure>
    <time_frame>5 days</time_frame>
    <description>Tele-diastolic volume / ventricular mass, LVEF on MRI on postoperative D5.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlations between clamping time and CEC and the size of the reperfusion lesions visible on MRI on D5 postoperative</measure>
    <time_frame>5 days</time_frame>
    <description>Correlation between clamping time and the size of the reperfusion lesions visible on MRI on D5 postoperative.&#xD;
Correlation between CEC time and the size of the reperfusion lesions visible on MRI on D5 postoperative.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exploratory evaluation of the kinetic profile of AUC with the type of lesion found on cardiac MRI (early peak, versus late peak).</measure>
    <time_frame>5 days</time_frame>
    <description>Correlation between the kinetic profile of AUC and the type of lesion found on MRI on D5 postoperative.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relation of functional and anatomical parameters of the right ventricle in 4 cavities and small axis (tele-diastolic volume, FEVD) evaluated by cardiac MRI on D5 postoperative.</measure>
    <time_frame>5 days</time_frame>
    <description>Correlation between the right ventricle in 4 cavities and small axis (2 differents measures) on MRI on D5 postoperative.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Cardiac Surgery</condition>
  <condition>Cardiopulmonary Bypass</condition>
  <arm_group>
    <arm_group_label>patients under aortic surgery with CPB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients under aortic surgery with CPB will have MRI and postoperative dosage of released troponin</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>1 MRI 5 days after surgery (-1; +4 days), with intravenous administration of gadolinium</description>
    <arm_group_label>patients under aortic surgery with CPB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Postoperative dosage of released troponin</intervention_name>
    <description>Dosage of troponin I Hs H4, H8, H12, H24, H48, and H72 after the aortic cross-unclamping.</description>
    <arm_group_label>patients under aortic surgery with CPB</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years old&#xD;
&#xD;
          -  Aortic valve surgery with CEC: aortic valve replacement, Bentall, Tirone-David, Wheat&#xD;
             with foreseeable clamping time of at least 40 minutes.&#xD;
&#xD;
          -  Informed consent signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  Other unconventional heart surgery&#xD;
&#xD;
          -  Aorto-coronary bypass associated with surgery&#xD;
&#xD;
          -  History of myocardial infarction or severe coronary artery disease, non-valvular&#xD;
             hypertrophic cardiomyopathy (MHC) (primary MHC type, Amyloidosis) and myocarditis&#xD;
&#xD;
          -  Preoperative alteration of systolic function of the left ventricle (LVEF &lt;40%)&#xD;
&#xD;
          -  Presence of a contraindication to cardiac MRI (claustrophobia, pacemaker or cardiac&#xD;
             defibrillator, metallic body, hypersensitivity to gadolinium)&#xD;
&#xD;
          -  Patients with a glomerular filtration rate (GFR) &lt;30 ml / min&#xD;
&#xD;
          -  Patients with permanent atrial fibrillation (ACFA) cardiac arrhythmia&#xD;
&#xD;
          -  Patients treated with anthracyclines&#xD;
&#xD;
          -  Pregnant and / or lactating woman&#xD;
&#xD;
          -  Patient under legal protection&#xD;
&#xD;
          -  Patient not benefiting from a social security system&#xD;
&#xD;
          -  Patient participating in another clinical study that may interfere with the results of&#xD;
             this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hôpital Louis Pradel</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>March 6, 2023</last_update_submitted>
  <last_update_submitted_qc>March 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiac surgery</keyword>
  <keyword>Cardiopulmonary bypass</keyword>
  <keyword>ischemia reperfusion</keyword>
  <keyword>Cardiac magnetic resonance imaging</keyword>
  <!-- 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/NCT04490785
org study id: 69HCL20_0020
nct id: NCT04490785
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Cardiac surgery under cardiopulmonary bypass (CPB) induces myocardial ischemia-reperfusion
      injury. This myocardial attack is a well-identified independent prognostic factor of
      postoperative morbidity and mortality. The quantification of these myocardial lesions by the
      postoperative plasma release of troponin has proven its diagnostic and prognostic value.

      Cardiac magnetic resonance imaging (MRI) can accurately measure and characterize the size of
      myocardial lesions. These lesions are associated with a poor prognosis. MRI can also
      characterize myocardial edema secondary to ischemia-reperfusion which has not yet been
      studied in the context of CPB. It is therefore necessary, in a mechanistic approach, to
      quantify the respective share of necrosis, edema and reperfusion lesions during cardiac
      surgery under CPB in order to better understand these phenomena and to propose effective
      strategies for the prevention of these myocardial lesions.the relationship between the
      postoperative release of troponin and the amount of myocardial necrosis and edema measured by
      cardiac MRI will be assessed.The hypothesis is to demonstrate a positive correlation between
      imaging and biology in order to better understand the perioperative myocardial lesion
      processes.

      This is an interventional study prospective, exploratory, in cardiac imaging, non-comparative
      and single-center, including 30 patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: correlation between cardiac MRI and the AUC of postoperative plasma released hsTnI.
time frame: 5 days
description: Correlation between the AUC of plasma hsTnI levels measured during the first 72 hours postoperatively (sequential basal assays then 4, 8, 12, 24, 48 and 72 hours after aortic unclamping) and the mass in grams of myocardial necrosis measured by the late enhancement in cardiac MRI on D5 postoperative. Correlations between MRI anatomical data and biological or ultrasound data will be assessed with the Pearson or Spearman correlation coefficient according to the distribution of variables and linear regression.
measure: Relationship between peak serum hsTnI and mass in grams of necrosis on MRI.
time frame: 5 days
description: Correlation between highest serum value recorded for each patient within 72 hours and the mass in grams of myocardial necrosis measured by the late enhancement in cardiac MRI on D5 postoperative.
measure: AUC / serum peak hsTnI relationship and relative size of the necrosis on MRI
time frame: 5 days
description: Correlation between the AUC of plasma hsTnI levels measured during the first 72 hours postoperatively (sequential basal assays then 4, 8, 12, 24, 48 and 72 hours after aortic unclamping) and percentage of left ventricular mass. Correlation between highest serum value recorded for each patient within 72 hours and percentage of left ventricular mass.
measure: Relationship of hsTnI levels at 24 hours after aortic unclamping and the mass in grams of necrosis on MRI.
time frame: 5 days
description: Correlation between the AUC of plasma hsTnI levels measured at 24 hours after aortic unclamping and the mass in grams of myocardial necrosis measured by the late enhancement in cardiac MRI on D5 postoperative.
measure: AUC / peak serum hsTnI relationship and intensity of edema
time frame: 5 days
description: Correlation between the AUC of plasma hsTnI levels measured during the first 72 hours postoperatively (sequential basal assays then 4, 8, 12, 24, 48 and 72 hours after aortic unclamping) and intensity of edema at MRI. Correlation between highest serum value recorded for each patient within 72 hours and intensity of edema at MRI
measure: AUC / hsTnI serum peak relationship and the presence of microvascular obstruction lesions on MRI on postoperative D5
time frame: 5 days
description: Correlation between the AUC of plasma hsTnI levels measured during the first 72 hours postoperatively (sequential basal assays then 4, 8, 12, 24, 48 and 72 hours after aortic unclamping) and the presence of microvascular obstruction lesions on MRI on postoperative D5.
Correlation between highest serum value recorded for each patient within 72 hours and the presence of microvascular obstruction lesions on MRI on postoperative D5.
measure: Relation of functional and anatomical parameters evaluated by cardiac MRI on postoperative D5.
time frame: 5 days
description: Tele-diastolic volume / ventricular mass, LVEF on MRI on postoperative D5.
measure: Correlations between clamping time and CEC and the size of the reperfusion lesions visible on MRI on D5 postoperative
time frame: 5 days
description: Correlation between clamping time and the size of the reperfusion lesions visible on MRI on D5 postoperative.
Correlation between CEC time and the size of the reperfusion lesions visible on MRI on D5 postoperative.
measure: Exploratory evaluation of the kinetic profile of AUC with the type of lesion found on cardiac MRI (early peak, versus late peak).
time frame: 5 days
description: Correlation between the kinetic profile of AUC and the type of lesion found on MRI on D5 postoperative.
measure: Relation of functional and anatomical parameters of the right ventricle in 4 cavities and small axis (tele-diastolic volume, FEVD) evaluated by cardiac MRI on D5 postoperative.
time frame: 5 days
description: Correlation between the right ventricle in 4 cavities and small axis (2 differents measures) on MRI on D5 postoperative.
arm group label: patients under aortic surgery with CPB
arm group type: Experimental
description: Patients under aortic surgery with CPB will have MRI and postoperative dosage of released troponin
intervention type: Procedure
intervention name: MRI
description: 1 MRI 5 days after surgery (-1; +4 days), with intravenous administration of gadolinium
arm group label: patients under aortic surgery with CPB
intervention type: Biological
intervention name: Postoperative dosage of released troponin
description: Dosage of troponin I Hs H4, H8, H12, H24, H48, and H72 after the aortic cross-unclamping.
arm group label: patients under aortic surgery with CPB
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor