xml: <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/NCT06020209</url>
    </required_header>
    <id_info>
      <org_study_id>CT-STEMI</org_study_id>
      <secondary_id>GR-2021-12372092</secondary_id>
      <nct_id>NCT06020209</nct_id>
    </id_info>
    <brief_title>CCT for Comprehensive Risk Stratification Following STEMI</brief_title>
    <acronym>CT-STEMI</acronym>
    <official_title>Cardiac Computed Tomography for Comprehensive Risk Stratification of Arrhythmic, Atherothrombotic and Heart Failure Events Following Reperfused ST-segment Elevation Myocardial Infarction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Turin, Italy</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>A.O.U. Città della Salute e della Scienza - Molinette Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Istituto Auxologico Italiano</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Messina</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Ministry of Health, Italy</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Turin, Italy</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>
        The CT-STEMI study aims to evaluate a comprehensive cardiac computed tomography (CCT)&#xD;
        protocol for assessing the risk of heart failure (HF), life-threatening arrhythmias (LTA),&#xD;
        and atherothrombotic events following ST-elevation myocardial infarction (STEMI). This&#xD;
        multicenter, prospective study has three main objectives:&#xD;
  &#xD;
          1. Comparing the diagnostic accuracy of the comprehensive CCT protocol with cardiac&#xD;
             magnetic resonance (CMR), considered the non-invasive gold standard.&#xD;
  &#xD;
          2. Determining the prognostic value of CCT in assessing myocardial tissue adverse features&#xD;
             related to STEMI.&#xD;
  &#xD;
          3. Evaluating the atherosclerotic burden in patients with post-acute STEMI.&#xD;
  &#xD;
        Two hundred patients will undergo both CCT and CMR in the post-acute phase, and their&#xD;
        follow-up will focus on monitoring HF, LTA, and ischemic events. The CT-STEMI study&#xD;
        represents the first attempt to assess the potential of CCT in providing a comprehensive risk&#xD;
        assessment following STEMI in a large contemporary population. The findings of this study&#xD;
        have the potential to revolutionize post-STEMI risk stratification practices.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background / State of Art&#xD;
  &#xD;
        STEMI remains a leading cause of mortality. In the first year, STEMI survivors face an&#xD;
        incident burden of heart failure (HF) as high as 25%, of ischemic events up to 18.3% and of&#xD;
        LTA up to 1.5%.&#xD;
  &#xD;
        CMR has emerged as the most potent tool to predict adverse left ventricular (LV) remodeling&#xD;
        following STEMI. Infarct size (IS), microvascular obstruction (MVO) and intramyocardial&#xD;
        hemorrhage (IMH) measured by CMR are all independent HF predictors, able to outperform&#xD;
        clinical and reperfusion parameters and to predict long-term adverse remodeling among&#xD;
        patients with initially preserved LV ejection fraction (LVEF).&#xD;
  &#xD;
        Systematic CMR implementation following STEMI into routine clinical practice is difficult for&#xD;
        several reasons, including limited availability, high costs as well as practical issues such&#xD;
        as time and staff allocation. Moreover, CMR does not assess the coronary tree failing to&#xD;
        provide a risk assessment comprehensive of the atherothrombotic component, beyond HF and&#xD;
        arrhythmias.&#xD;
  &#xD;
        Since recent advances in CCT technology have expanded its applicability beyond accurate&#xD;
        morpho-functional assessment to the characterization of the myocardium, allowing for&#xD;
        quantification of IS, MVO and extracellular volume (ECV). CCT may now offer unprecedent&#xD;
        opportunities to provide a comprehensive risk assessment following STEMI with an&#xD;
        ever-increasing available technology, with moderate costs and logistic effectiveness, and&#xD;
        with very low radiation dose exposure with current scanners and protocols.&#xD;
  &#xD;
        Hypotesis and Significance&#xD;
  &#xD;
        Despite giant leaps forward in the acute and chronic management, STEMI remains a leading&#xD;
        cause of mortality and morbidity worldwide.&#xD;
  &#xD;
        Risk stratification is the foundation to tailoring treatment selection and intensity.&#xD;
        However, the current tools to predict adverse events following STEMI including HF&#xD;
        development, recurrent atherothrombotic events and life-threatening arrhythmias have poor&#xD;
        prediction abilities or require cumbersome and often unavailable diagnostic technologies.&#xD;
  &#xD;
        CMR has emerged as the most potent tool to predict adverse LV) remodeling following STEMI.&#xD;
        Current post-MI arrhythmic risk stratification to mandate implantable cardioverter&#xD;
        defibrillator implantation is chiefly based on LV EF. However, the evaluation of scar burden&#xD;
        by CMR may outperform EF to predict life-threatening arrhythmias and has the potential to&#xD;
        improve management among patients without a current indication for an implantable&#xD;
        cardioverter defibrillator.&#xD;
  &#xD;
        Systematic CMR implementation following STEMI into routine clinical practice is difficult for&#xD;
        several reasons, including limited availability, high costs as well as practical issues such&#xD;
        as time and staff allocation. Moreover, while providing excellent myocardial tissue&#xD;
        characterization, CMR does not assess the coronary tree failing to provide a risk assessment&#xD;
        comprehensive of the atherothrombotic component, beyond HF and arrhythmias.&#xD;
  &#xD;
        Since recent advances in CCT technology have expanded its applicability beyond accurate&#xD;
        morpho-functional assessment to the characterization of the myocardium, CCT may now offer&#xD;
        unprecedent opportunities to provide a comprehensive risk assessment following STEMI with an&#xD;
        ever-increasing available technology, with moderate costs and logistic effectiveness, and&#xD;
        with very low radiation dose exposure with current scanners and protocols.&#xD;
  &#xD;
        While preliminary data on the CCT performance to assess myocardial tissue characteristics are&#xD;
        promising, accurate validation of this technology against CMR and clinical outcomes in large&#xD;
        populations will be pivotal for clinical implementation. Moreover, the application of this&#xD;
        technology to stratify HF and arrhythmic risk following STEMI has never been assessed.&#xD;
  &#xD;
        The CT-STEMI study will be the first to assess the potential of CCT to provide a&#xD;
        comprehensive risk assessment following STEMI in a large contemporary population, to lay the&#xD;
        bases for a paradigm shift in post-STEMI risk stratification.&#xD;
  &#xD;
        Specific Aim 1 To compare the diagnostic accuracy of a comprehensive CCT protocol to that of&#xD;
        CMR, the non-invasive gold standard.&#xD;
  &#xD;
        Specific Aim 2 To determine the prognostic value of CCT-assessed myocardial tissue&#xD;
        STEMI-related adverse features.&#xD;
  &#xD;
        Specific Aim 3 To evaluate the atherosclerotic burden in patients with post-acute STEMI.&#xD;
  &#xD;
        For this purpose, in this prospective study, a total of two hundred patients will be&#xD;
        recruited and undergo coronary computed tomography (CCT) and cardiac magnetic resonance&#xD;
        imaging (CMR) during the post-acute phase of ST-elevation myocardial infarction (STEMI).&#xD;
  &#xD;
        Experimental Design Aim 1&#xD;
  &#xD;
        The CMR study will be used as the reference standard to assess the accuracy of CCT in&#xD;
        evaluating morpho-functional parameters such as Left Ventricular End-Diastolic Volume&#xD;
        (LVEDV), Left Ventricular End-Systolic Volume (LVESV), LVEF, Right Ventricular End-Diastolic&#xD;
        Volume (RVEDV), Right Ventricular End-Systolic Volume (RVESV), and Right Ventricular Ejection&#xD;
        Fraction (RVEF). Additionally, the study will also examine myocardial tissue characteristics&#xD;
        including IS, myocardial edema, MVO, IMH, and ECV.&#xD;
  &#xD;
        Experimental Design Aim 2&#xD;
  &#xD;
        The patients will undergo follow-up procedures starting from the commencement of the study.&#xD;
        Co-primary endpoints will be:&#xD;
  &#xD;
          -  Atherothrombotic primary endpoint: composite of recurrent acute coronary syndrome,&#xD;
             ischemic stroke or cardiovascular death&#xD;
  &#xD;
          -  HF and arrhythmic primary endpoint: composite of new congestive HF or sustained&#xD;
             ventricular arrhythmia or appropriate Implantable Cardioverter-Defibrillator (ICD)&#xD;
             intervention or sudden cardiac death or resuscitated cardiac arrest&#xD;
  &#xD;
        Individual CCT predictors (EF, IS, myocardial edema, MVO, IMH and ECV) will be evaluated and&#xD;
        compared with those derived from CMR.&#xD;
  &#xD;
        Experimental Design Aim 3&#xD;
  &#xD;
        The purpose of this sub-study is to report the prevalence and features of non-culprit&#xD;
        plaques, as well as to investigate the independent predictive significance of CCT-assessed&#xD;
        coronary plaque characteristics on event prediction.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2026</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>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>CCT - diagnostic accuracy</measure>
      <time_frame>Baseline</time_frame>
      <description>CMR study will be used as the reference standard to assess the accuracy of CCT in evaluating morpho-functional parameters such as&#xD;
  LVEDV (ml)&#xD;
  LVESV (ml)&#xD;
  LVEF (%)&#xD;
  RVEDV (ml)&#xD;
  RVESV (ml)&#xD;
  RVEF (%)&#xD;
  Additionally, the study will also examine myocardial tissue characteristics including:&#xD;
  IS: presence or absence&#xD;
  IS (gr)&#xD;
  IS (% of the total left ventricular mass)&#xD;
  Myocardial edema: presence or absence&#xD;
  Myocardial edema (gr)&#xD;
  Myocardial edema (% of the total left ventricular mass)&#xD;
  MVO: presence or absence&#xD;
  MVO (gr)&#xD;
  MVO (% of the total left ventricular mass)&#xD;
  IMH: presence or absence&#xD;
  IMH (gr)&#xD;
  IMH (% of the total left ventricular mass)&#xD;
  ECV (%)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>CCT - risk stratification</measure>
      <time_frame>1 month, 1 year</time_frame>
      <description>Individual CCT predictors will be evaluated and compared with those derived from CMR:&#xD;
  IS: presence or absence&#xD;
  IS (gr)&#xD;
  IS (% of the total left ventricular mass)&#xD;
  Myocardial edema: presence or absence&#xD;
  Myocardial edema (gr)&#xD;
  Myocardial edema (% of the total left ventricular mass)&#xD;
  MVO: presence or absence&#xD;
  MVO (gr)&#xD;
  MVO (% of the total left ventricular mass)&#xD;
  IMH: presence or absence&#xD;
  IMH (gr)&#xD;
  IMH (% of the total left ventricular mass)&#xD;
  ECV (%)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>CCT - Coronary artery disease (CAD) impact of risk stratification</measure>
      <time_frame>Baseline, 1 month, 1 year</time_frame>
      <description>CCT Report include prevalence and features of non-culprit plaques with a qualitative analysis, based on the presence of:&#xD;
  positive remodeling: presence or absence&#xD;
  low attenuation plaque: presence or absence&#xD;
  spotty calcification: presence or absence&#xD;
  &quot;napkin ring&quot; sign: presence or absence&#xD;
  and semi-quantitative analysis with a dedicated cardiac CT software:&#xD;
  Plaque burden (%)&#xD;
  Plaque volume (per lesion and per vessel) (mm^3)&#xD;
  Vessel remodeling index (ratio)&#xD;
  Mean plaque and lumen intensities (HU)&#xD;
  Plaque characterization components: presence or absence of Dense Calcium, Necrotic Core, Fibrous Fatty, Fibrous&#xD;
  Evaluation of Peri Vascular Adipose Tissue (PVAT) - thickness measurement in millimeters (mm)&#xD;
  Evaluation of Peri Vascular Adipose Tissue (PVAT) - volume measurement in millimeters cubed (mm^3)&#xD;
  Finally this data will used to investigate the independent predictive significance of CCT-assessed coronary plaque characteristics on event prediction.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Myocardial Infarction</condition>
    <arm_group>
      <arm_group_label>STEMI patients</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with reperfused ST-segment Elevation Myocardial Infarction</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Cardiac Computed Tomography</intervention_name>
      <description>A comprehensive CCT protocol will be performed in the post-acute phase of STEMI. Specifically, the CCT protocol will include a pre-contrast scan and an angiographic scan ( also set up to assess ventricular volume and function) followed by late contrast enhancement scan.</description>
      <arm_group_label>STEMI patients</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Cardiac Magnetic Resonance</intervention_name>
      <description>A comprehensive CMR protocol will be performed in the post-acute phase of STEMI. Specifically, the CMR protocol is designed for morpho-functional analysis and tissue characterisation (including assessment of late gadolinium enhancement and mapping). CMR will be considered the gold standard.</description>
      <arm_group_label>STEMI patients</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Signed informed consent&#xD;
  &#xD;
            -  STEMI diagnosis&#xD;
  &#xD;
            -  Primary Percutaneous Coronary Intervention (PCI) &lt;24h from symptom onset&#xD;
  &#xD;
            -  Hemodynamic stability without inotropic support within 4 days from the index event&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known chronic kidney disease with estimated Glomerular Filtration Rate (GFR) &lt; 30&#xD;
               mL/min/1.73mq&#xD;
  &#xD;
            -  History of allergic reaction to CCT or CMR contrast media&#xD;
  &#xD;
            -  Inability or unwilling to undergo CCT or CMR scanning&#xD;
  &#xD;
            -  Pregnancy or breast-feeding&#xD;
  &#xD;
            -  Severe atrial or ventricular arrhythmia burden&#xD;
  &#xD;
            -  Severe valvular stenosis or regurgitation&#xD;
  &#xD;
            -  Prior clinical congestive HF diagnosis (asymptomatic LV dysfunction can be included)&#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>Marco Gatti, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Turin, Italy</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marco Gatti, M.D.</last_name>
      <phone>+390116334175</phone>
      <email>m.gatti@unito.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>Azienda Ospedaliera Policlinico Universitario &quot;G. Martino&quot;</name>
        <address>
          <city>Messina</city>
          <zip>98124</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tommaso D'Angelo, M.D.</last_name>
        <email>tommasodang@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Tommaso D'Angelo, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Istituto Auxologico Italiano - IRCCS - Ospedale San Luca</name>
        <address>
          <city>Milan</city>
          <zip>20149</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Camilla Torlasco, M.D.</last_name>
        <email>c.torlasco@auxologico.it</email>
      </contact>
      <investigator>
        <last_name>Camilla Torlasco, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>A.O.U. Città della Salute e della Scienza - Molinette Hospital</name>
        <address>
          <city>Turin</city>
          <zip>10126</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Marco Gatti, M.D.</last_name>
        <phone>+390116334175</phone>
        <email>m.gatti@unito.it</email>
      </contact>
      <investigator>
        <last_name>Marco Gatti, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Alessandro Andreis, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Turin, Italy</investigator_affiliation>
      <investigator_full_name>Marco Gatti</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>ST Elevation Myocardial Infarction</keyword>
    <keyword>Coronary Artery Disease</keyword>
    <keyword>Computed Tomography (CT)</keyword>
    <keyword>Cardiovascular Magnetic Resonance (CMR)</keyword>
    <keyword>Risk assessment</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>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>
  
  
text: 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/NCT06020209
  org study id: CT-STEMI
  secondary id: GR-2021-12372092
  nct id: NCT06020209
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The CT-STEMI study aims to evaluate a comprehensive cardiac computed tomography (CCT)
        protocol for assessing the risk of heart failure (HF), life-threatening arrhythmias (LTA),
        and atherothrombotic events following ST-elevation myocardial infarction (STEMI). This
        multicenter, prospective study has three main objectives:
  
          1. Comparing the diagnostic accuracy of the comprehensive CCT protocol with cardiac
             magnetic resonance (CMR), considered the non-invasive gold standard.
  
          2. Determining the prognostic value of CCT in assessing myocardial tissue adverse features
             related to STEMI.
  
          3. Evaluating the atherosclerotic burden in patients with post-acute STEMI.
  
        Two hundred patients will undergo both CCT and CMR in the post-acute phase, and their
        follow-up will focus on monitoring HF, LTA, and ischemic events. The CT-STEMI study
        represents the first attempt to assess the potential of CCT in providing a comprehensive risk
        assessment following STEMI in a large contemporary population. The findings of this study
        have the potential to revolutionize post-STEMI risk stratification practices.
  Background / State of Art
  
        STEMI remains a leading cause of mortality. In the first year, STEMI survivors face an
        incident burden of heart failure (HF) as high as 25%, of ischemic events up to 18.3% and of
        LTA up to 1.5%.
  
        CMR has emerged as the most potent tool to predict adverse left ventricular (LV) remodeling
        following STEMI. Infarct size (IS), microvascular obstruction (MVO) and intramyocardial
        hemorrhage (IMH) measured by CMR are all independent HF predictors, able to outperform
        clinical and reperfusion parameters and to predict long-term adverse remodeling among
        patients with initially preserved LV ejection fraction (LVEF).
  
        Systematic CMR implementation following STEMI into routine clinical practice is difficult for
        several reasons, including limited availability, high costs as well as practical issues such
        as time and staff allocation. Moreover, CMR does not assess the coronary tree failing to
        provide a risk assessment comprehensive of the atherothrombotic component, beyond HF and
        arrhythmias.
  
        Since recent advances in CCT technology have expanded its applicability beyond accurate
        morpho-functional assessment to the characterization of the myocardium, allowing for
        quantification of IS, MVO and extracellular volume (ECV). CCT may now offer unprecedent
        opportunities to provide a comprehensive risk assessment following STEMI with an
        ever-increasing available technology, with moderate costs and logistic effectiveness, and
        with very low radiation dose exposure with current scanners and protocols.
  
        Hypotesis and Significance
  
        Despite giant leaps forward in the acute and chronic management, STEMI remains a leading
        cause of mortality and morbidity worldwide.
  
        Risk stratification is the foundation to tailoring treatment selection and intensity.
        However, the current tools to predict adverse events following STEMI including HF
        development, recurrent atherothrombotic events and life-threatening arrhythmias have poor
        prediction abilities or require cumbersome and often unavailable diagnostic technologies.
  
        CMR has emerged as the most potent tool to predict adverse LV) remodeling following STEMI.
        Current post-MI arrhythmic risk stratification to mandate implantable cardioverter
        defibrillator implantation is chiefly based on LV EF. However, the evaluation of scar burden
        by CMR may outperform EF to predict life-threatening arrhythmias and has the potential to
        improve management among patients without a current indication for an implantable
        cardioverter defibrillator.
  
        Systematic CMR implementation following STEMI into routine clinical practice is difficult for
        several reasons, including limited availability, high costs as well as practical issues such
        as time and staff allocation. Moreover, while providing excellent myocardial tissue
        characterization, CMR does not assess the coronary tree failing to provide a risk assessment
        comprehensive of the atherothrombotic component, beyond HF and arrhythmias.
  
        Since recent advances in CCT technology have expanded its applicability beyond accurate
        morpho-functional assessment to the characterization of the myocardium, CCT may now offer
        unprecedent opportunities to provide a comprehensive risk assessment following STEMI with an
        ever-increasing available technology, with moderate costs and logistic effectiveness, and
        with very low radiation dose exposure with current scanners and protocols.
  
        While preliminary data on the CCT performance to assess myocardial tissue characteristics are
        promising, accurate validation of this technology against CMR and clinical outcomes in large
        populations will be pivotal for clinical implementation. Moreover, the application of this
        technology to stratify HF and arrhythmic risk following STEMI has never been assessed.
  
        The CT-STEMI study will be the first to assess the potential of CCT to provide a
        comprehensive risk assessment following STEMI in a large contemporary population, to lay the
        bases for a paradigm shift in post-STEMI risk stratification.
  
        Specific Aim 1 To compare the diagnostic accuracy of a comprehensive CCT protocol to that of
        CMR, the non-invasive gold standard.
  
        Specific Aim 2 To determine the prognostic value of CCT-assessed myocardial tissue
        STEMI-related adverse features.
  
        Specific Aim 3 To evaluate the atherosclerotic burden in patients with post-acute STEMI.
  
        For this purpose, in this prospective study, a total of two hundred patients will be
        recruited and undergo coronary computed tomography (CCT) and cardiac magnetic resonance
        imaging (CMR) during the post-acute phase of ST-elevation myocardial infarction (STEMI).
  
        Experimental Design Aim 1
  
        The CMR study will be used as the reference standard to assess the accuracy of CCT in
        evaluating morpho-functional parameters such as Left Ventricular End-Diastolic Volume
        (LVEDV), Left Ventricular End-Systolic Volume (LVESV), LVEF, Right Ventricular End-Diastolic
        Volume (RVEDV), Right Ventricular End-Systolic Volume (RVESV), and Right Ventricular Ejection
        Fraction (RVEF). Additionally, the study will also examine myocardial tissue characteristics
        including IS, myocardial edema, MVO, IMH, and ECV.
  
        Experimental Design Aim 2
  
        The patients will undergo follow-up procedures starting from the commencement of the study.
        Co-primary endpoints will be:
  
          -  Atherothrombotic primary endpoint: composite of recurrent acute coronary syndrome,
             ischemic stroke or cardiovascular death
  
          -  HF and arrhythmic primary endpoint: composite of new congestive HF or sustained
             ventricular arrhythmia or appropriate Implantable Cardioverter-Defibrillator (ICD)
             intervention or sudden cardiac death or resuscitated cardiac arrest
  
        Individual CCT predictors (EF, IS, myocardial edema, MVO, IMH and ECV) will be evaluated and
        compared with those derived from CMR.
  
        Experimental Design Aim 3
  
        The purpose of this sub-study is to report the prevalence and features of non-culprit
        plaques, as well as to investigate the independent predictive significance of CCT-assessed
        coronary plaque characteristics on event prediction.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: CCT - diagnostic accuracy
  time frame: Baseline
  description: CMR study will be used as the reference standard to assess the accuracy of CCT in evaluating morpho-functional parameters such as
  LVEDV (ml)
  LVESV (ml)
  LVEF (%)
  RVEDV (ml)
  RVESV (ml)
  RVEF (%)
  Additionally, the study will also examine myocardial tissue characteristics including:
  IS: presence or absence
  IS (gr)
  IS (% of the total left ventricular mass)
  Myocardial edema: presence or absence
  Myocardial edema (gr)
  Myocardial edema (% of the total left ventricular mass)
  MVO: presence or absence
  MVO (gr)
  MVO (% of the total left ventricular mass)
  IMH: presence or absence
  IMH (gr)
  IMH (% of the total left ventricular mass)
  ECV (%)
  measure: CCT - risk stratification
  time frame: 1 month, 1 year
  description: Individual CCT predictors will be evaluated and compared with those derived from CMR:
  IS: presence or absence
  IS (gr)
  IS (% of the total left ventricular mass)
  Myocardial edema: presence or absence
  Myocardial edema (gr)
  Myocardial edema (% of the total left ventricular mass)
  MVO: presence or absence
  MVO (gr)
  MVO (% of the total left ventricular mass)
  IMH: presence or absence
  IMH (gr)
  IMH (% of the total left ventricular mass)
  ECV (%)
  measure: CCT - Coronary artery disease (CAD) impact of risk stratification
  time frame: Baseline, 1 month, 1 year
  description: CCT Report include prevalence and features of non-culprit plaques with a qualitative analysis, based on the presence of:
  positive remodeling: presence or absence
  low attenuation plaque: presence or absence
  spotty calcification: presence or absence
  "napkin ring" sign: presence or absence
  and semi-quantitative analysis with a dedicated cardiac CT software:
  Plaque burden (%)
  Plaque volume (per lesion and per vessel) (mm^3)
  Vessel remodeling index (ratio)
  Mean plaque and lumen intensities (HU)
  Plaque characterization components: presence or absence of Dense Calcium, Necrotic Core, Fibrous Fatty, Fibrous
  Evaluation of Peri Vascular Adipose Tissue (PVAT) - thickness measurement in millimeters (mm)
  Evaluation of Peri Vascular Adipose Tissue (PVAT) - volume measurement in millimeters cubed (mm^3)
  Finally this data will used to investigate the independent predictive significance of CCT-assessed coronary plaque characteristics on event prediction.
  arm group label: STEMI patients
  arm group type: Experimental
  description: Patients with reperfused ST-segment Elevation Myocardial Infarction
  intervention type: Diagnostic Test
  intervention name: Cardiac Computed Tomography
  description: A comprehensive CCT protocol will be performed in the post-acute phase of STEMI. Specifically, the CCT protocol will include a pre-contrast scan and an angiographic scan ( also set up to assess ventricular volume and function) followed by late contrast enhancement scan.
  arm group label: STEMI patients
  intervention type: Diagnostic Test
  intervention name: Cardiac Magnetic Resonance
  description: A comprehensive CMR protocol will be performed in the post-acute phase of STEMI. Specifically, the CMR protocol is designed for morpho-functional analysis and tissue characterisation (including assessment of late gadolinium enhancement and mapping). CMR will be considered the gold standard.
  arm group label: STEMI patients
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Marco Gatti, M.D.
  role: Principal Investigator
  affiliation: University of Turin, Italy
  last name: Marco Gatti, M.D.
  phone: +390116334175
  email: m.gatti@unito.it
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: University of Turin, Italy
  investigator full name: Marco Gatti
  investigator title: Principal Investigator
  mesh term: Myocardial Infarction
  mesh term: Infarction
  sharing ipd: No