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/NCT06029400</url>
    </required_header>
    <id_info>
      <org_study_id>CTMyoC</org_study_id>
      <nct_id>NCT06029400</nct_id>
    </id_info>
    <brief_title>CT-based Myocardial Characterization (CTMyoC)</brief_title>
    <acronym>CTMyoC</acronym>
    <official_title>CT-based Myocardial Characterization</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>IRCCS San Raffaele</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>IRCCS San Raffaele</source>
    <oversight_info>
      <has_dmc>No</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 identification of myocardial fibrosis in term of myocardial scar and extracellular matrix&#xD;
        remodelling assessed respectively with the technique of Late Gadolinium Enhancement (LGE) and&#xD;
        with the quantification of the Extracellular Volume Fraction (ECV) in Cardiac Magnetic&#xD;
        Resonance has been demonstrated to be crucial in the diagnosis of different cardiomyopathy&#xD;
        and to be prognosticators of major cardiovascular adverse events [1-14].&#xD;
  &#xD;
        For these reason CMR represent the gold standard for the non-invasive characterization of&#xD;
        myocardial tissue in the clinical practice.&#xD;
  &#xD;
        However, regardless of its indisputable clinical role, CMR has many limitations: 1) it does&#xD;
        not allow to evaluate coronary arteries; 2) it is contraindicated in patients with cardiac&#xD;
        devices, and in case of conditional device they may also significantly impair LGE&#xD;
        assessability due to artefacts [19]); 2) has limited availability and it is time consuming,&#xD;
        therefore it is difficult to perform in the acute setting also because of poor patient&#xD;
        compliance; 3) it is not feasible in patients suffering from claustrophobia. Cardiac Computed&#xD;
        Tomography (cCT) is the image of choice to non-invasively study coronary arteries, not&#xD;
        assessable with CMR. Moreover the recent technological advancement has continuously increased&#xD;
        the clinical indication to the evaluation of cardiac valve and fibrosis, with reduced&#xD;
        acquisition time respect to CMR (few minutes vs 1 hour), radiation exposure and costs.&#xD;
  &#xD;
        cCT has emerging as a possible alternative to CMR in the characterization of myocardial scar&#xD;
        and extracellular volume fraction, with the advantage of a single shot evaluation of coronary&#xD;
        arteries and myocardial tissue remodelling (scar, diffuse fibrosis, contractility..).In&#xD;
        particular, several studies including some from our group, have demonstrated the clinical&#xD;
        utility of myocardial tissue characterization with cCT in different clinical settings, such&#xD;
        as myocardial infarction [20, 21], myocarditis [22], hypertrophic cardiomyopathy (HCM) [23],&#xD;
        heart failure [24], ventricular tachycardia [25], and sarcoidosis [26]. Despite the&#xD;
        interesting results, all these previous studies are limited on highly selected and small&#xD;
        sample size. Moreover, any large study with long term follow-up is available in the setting&#xD;
        of tissue characterization (myocardial scar and ECV) in cCT also as well as combined with a&#xD;
        multiparametric approach (cardiac chamber morphofuntionality,contractility-strain, valve&#xD;
        calcification, geometry, coronary atherosclerosis, myocardial perfusion, myocardial strain&#xD;
        and texture) and no data are available about its prognostic impact. Aim of the study is to&#xD;
        evaluate the potential of cCT in tissue characterization (myocardial scar and ECV) alone and&#xD;
        associate to other CT imaging biomarker on a large population of patient clinically candidate&#xD;
        to cardiac CT.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 12, 2020</start_date>
    <completion_date type="Anticipated">October 12, 2032</completion_date>
    <primary_completion_date type="Anticipated">October 12, 2032</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Composite outcome</measure>
      <time_frame>60 months</time_frame>
      <description>first hospitalization for heart failure (HHF) or death (all-cause mortality).</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">2200</enrollment>
    <condition>Different Cardiomyopathy and Major Cardiovascular Adverse Events</condition>
    <arm_group>
      <arm_group_label>Retrospective cohort</arm_group_label>
      <description>The retrospective arm of the study will include 200 patients meeting the inclusion criteria who have received a cardiac CT from January 2013 to date of approval amendment. (2013 was chosen as starting year to retrieve CT and clinical date in order to have at least 5 years of follow-up per patients).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Prospective cohort</arm_group_label>
      <description>The prospective arm of the study will include 2000 consecutive patients meeting the inclusion criteria, candidate to cardiac CT along the 7 years after date of approval.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          This is a monocentric observational study with a retrospective and a prospective arms.&#xD;
  &#xD;
          Patients will be recruited from the Radiology Department of our Institution (IRCCS Ospedale&#xD;
          San Raffaele, Milan, Italy). Written informed consent will be obtained.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          a) age ≥ 18 years; b) no contraindication to cCT; c) signed informed consen; d) clinical&#xD;
          indication to cCT for the following reason: stable angina, heart failure, atrial/&#xD;
          ventricular arrhythmias, acute chest pain with need of &quot;triple-rule-out&quot; scan, planning of&#xD;
          valvular repair/substitution, structural and infiltrative cardiomyopathy, new onset ECG&#xD;
          alteration, troponin increase.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          (a) age &lt; 18 years; (b) pregnancy and/or breastfeeding; (c) contraindications to iodinated&#xD;
          contrast agent administration or impaired renal function (eGFR ≤ 30 mL/min); (d) inability&#xD;
          to sustain a brief breath hold (5 seconds).&#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_contact>
      <last_name>Antonio Esposito</last_name>
      <phone>02 2643 6102</phone>
      <email>esposito.antonio@hsr.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Anna Palmisano</last_name>
      <email>palmisano.anna@hsr.it</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>IRCCS San Raffaele</name>
        <address>
          <city>Milano</city>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Antonio Esposito</last_name>
        <phone>02 2643 6102</phone>
        <email>esposito.antonio@hsr.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <reference>
      <citation>Mewton N, Liu CY, Croisille P, Bluemke D, Lima JA. Assessment of myocardial fibrosis with cardiovascular magnetic resonance. J Am Coll Cardiol. 2011 Feb 22;57(8):891-903. doi: 10.1016/j.jacc.2010.11.013.</citation>
      <PMID>21329834</PMID>
    </reference>
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      <citation>Kuruvilla S, Adenaw N, Katwal AB, Lipinski MJ, Kramer CM, Salerno M. Late gadolinium enhancement on cardiac magnetic resonance predicts adverse cardiovascular outcomes in nonischemic cardiomyopathy: a systematic review and meta-analysis. Circ Cardiovasc Imaging. 2014 Mar;7(2):250-258. doi: 10.1161/CIRCIMAGING.113.001144. Epub 2013 Dec 20.</citation>
      <PMID>24363358</PMID>
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      <citation>Mavrogeni S, Petrou E, Kolovou G, Theodorakis G, Iliodromitis E. Prediction of ventricular arrhythmias using cardiovascular magnetic resonance. Eur Heart J Cardiovasc Imaging. 2013 Jun;14(6):518-25. doi: 10.1093/ehjci/jes302. Epub 2013 Jan 16.</citation>
      <PMID>23324829</PMID>
    </reference>
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      <citation>Weng Z, Yao J, Chan RH, He J, Yang X, Zhou Y, He Y. Prognostic Value of LGE-CMR in HCM: A Meta-Analysis. JACC Cardiovasc Imaging. 2016 Dec;9(12):1392-1402. doi: 10.1016/j.jcmg.2016.02.031. Epub 2016 Jul 20.</citation>
      <PMID>27450876</PMID>
    </reference>
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      <citation>Haaf P, Garg P, Messroghli DR, Broadbent DA, Greenwood JP, Plein S. Cardiac T1 Mapping and Extracellular Volume (ECV) in clinical practice: a comprehensive review. J Cardiovasc Magn Reson. 2016 Nov 30;18(1):89. doi: 10.1186/s12968-016-0308-4.</citation>
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      <citation>Youn JC, Hong YJ, Lee HJ, Han K, Shim CY, Hong GR, Suh YJ, Hur J, Kim YJ, Choi BW, Kang SM. Contrast-enhanced T1 mapping-based extracellular volume fraction independently predicts clinical outcome in patients with non-ischemic dilated cardiomyopathy: a prospective cohort study. Eur Radiol. 2017 Sep;27(9):3924-3933. doi: 10.1007/s00330-017-4817-9. Epub 2017 Apr 24.</citation>
      <PMID>28439651</PMID>
    </reference>
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      <citation>Ferreira VM, Piechnik SK, Dall'Armellina E, Karamitsos TD, Francis JM, Ntusi N, Holloway C, Choudhury RP, Kardos A, Robson MD, Friedrich MG, Neubauer S. T(1) mapping for the diagnosis of acute myocarditis using CMR: comparison to T2-weighted and late gadolinium enhanced imaging. JACC Cardiovasc Imaging. 2013 Oct;6(10):1048-1058. doi: 10.1016/j.jcmg.2013.03.008. Epub 2013 Sep 4.</citation>
      <PMID>24011774</PMID>
    </reference>
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      <citation>Hinojar R, Varma N, Child N, Goodman B, Jabbour A, Yu CY, Gebker R, Doltra A, Kelle S, Khan S, Rogers T, Arroyo Ucar E, Cummins C, Carr-White G, Nagel E, Puntmann VO. T1 Mapping in Discrimination of Hypertrophic Phenotypes: Hypertensive Heart Disease and Hypertrophic Cardiomyopathy: Findings From the International T1 Multicenter Cardiovascular Magnetic Resonance Study. Circ Cardiovasc Imaging. 2015 Dec;8(12):e003285. doi: 10.1161/CIRCIMAGING.115.003285.</citation>
      <PMID>26659373</PMID>
    </reference>
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      <citation>Puntmann VO, Isted A, Hinojar R, Foote L, Carr-White G, Nagel E. T1 and T2 Mapping in Recognition of Early Cardiac Involvement in Systemic Sarcoidosis. Radiology. 2017 Oct;285(1):63-72. doi: 10.1148/radiol.2017162732. Epub 2017 Apr 27.</citation>
      <PMID>28448233</PMID>
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      <citation>Martinez-Naharro A, Kotecha T, Norrington K, Boldrini M, Rezk T, Quarta C, Treibel TA, Whelan CJ, Knight DS, Kellman P, Ruberg FL, Gillmore JD, Moon JC, Hawkins PN, Fontana M. Native T1 and Extracellular Volume in Transthyretin Amyloidosis. JACC Cardiovasc Imaging. 2019 May;12(5):810-819. doi: 10.1016/j.jcmg.2018.02.006. Epub 2018 Mar 14.</citation>
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      <PMID>29688154</PMID>
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      <PMID>23228924</PMID>
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      <citation>Treibel TA, Fridman Y, Bering P, Sayeed A, Maanja M, Frojdh F, Niklasson L, Olausson E, Wong TC, Kellman P, Miller CA, Moon JC, Ugander M, Schelbert EB. Extracellular Volume Associates With Outcomes More Strongly Than Native or Post-Contrast Myocardial T1. JACC Cardiovasc Imaging. 2020 Jan;13(1 Pt 1):44-54. doi: 10.1016/j.jcmg.2019.03.017. Epub 2019 May 15.</citation>
      <PMID>31103587</PMID>
    </reference>
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      <citation>Barone-Rochette G, Pierard S, De Meester de Ravenstein C, Seldrum S, Melchior J, Maes F, Pouleur AC, Vancraeynest D, Pasquet A, Vanoverschelde JL, Gerber BL. Prognostic significance of LGE by CMR in aortic stenosis patients undergoing valve replacement. J Am Coll Cardiol. 2014 Jul 15;64(2):144-54. doi: 10.1016/j.jacc.2014.02.612.</citation>
      <PMID>25011718</PMID>
    </reference>
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      <citation>Chin CWL, Everett RJ, Kwiecinski J, Vesey AT, Yeung E, Esson G, Jenkins W, Koo M, Mirsadraee S, White AC, Japp AG, Prasad SK, Semple S, Newby DE, Dweck MR. Myocardial Fibrosis and Cardiac Decompensation in Aortic Stenosis. JACC Cardiovasc Imaging. 2017 Nov;10(11):1320-1333. doi: 10.1016/j.jcmg.2016.10.007. Epub 2016 Dec 21.</citation>
      <PMID>28017384</PMID>
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      <citation>Chaikriangkrai K, Lopez-Mattei JC, Lawrie G, Ibrahim H, Quinones MA, Zoghbi W, Little SH, Shah DJ. Prognostic value of delayed enhancement cardiac magnetic resonance imaging in mitral valve repair. Ann Thorac Surg. 2014 Nov;98(5):1557-63. doi: 10.1016/j.athoracsur.2014.06.049. Epub 2014 Sep 18.</citation>
      <PMID>25240782</PMID>
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      <citation>Steen H, Madadi-Schroeder M, Lehrke S, Lossnitzer D, Giannitsis E, Katus HA. Staged cardiovascular magnetic resonance for differential diagnosis of troponin T positive patients with low likelihood for acute coronary syndrome. J Cardiovasc Magn Reson. 2010 Sep 14;12(1):51. doi: 10.1186/1532-429X-12-51.</citation>
      <PMID>20840783</PMID>
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      <citation>Dickfeld T, Tian J, Ahmad G, Jimenez A, Turgeman A, Kuk R, Peters M, Saliaris A, Saba M, Shorofsky S, Jeudy J. MRI-Guided ventricular tachycardia ablation: integration of late gadolinium-enhanced 3D scar in patients with implantable cardioverter-defibrillators. Circ Arrhythm Electrophysiol. 2011 Apr;4(2):172-84. doi: 10.1161/CIRCEP.110.958744. Epub 2011 Jan 26.</citation>
      <PMID>21270103</PMID>
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      <citation>Tanabe Y, Kido T, Kurata A, Kouchi T, Fukuyama N, Yokoi T, Uetani T, Yamashita N, Miyagawa M, Mochizuki T. Late iodine enhancement computed tomography with image subtraction for assessment of myocardial infarction. Eur Radiol. 2018 Mar;28(3):1285-1292. doi: 10.1007/s00330-017-5048-9. Epub 2017 Sep 19.</citation>
      <PMID>28929333</PMID>
    </reference>
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      <citation>Rodriguez-Granillo GA. Delayed enhancement cardiac computed tomography for the assessment of myocardial infarction: from bench to bedside. Cardiovasc Diagn Ther. 2017 Apr;7(2):159-170. doi: 10.21037/cdt.2017.03.16.</citation>
      <PMID>28540211</PMID>
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      <citation>Bouleti C, Baudry G, Iung B, Arangalage D, Abtan J, Ducrocq G, Steg PG, Vahanian A, Henry-Feugeas MC, Pasi N, Chillon S, Pitocco F, Laissy JP, Ou P. Usefulness of Late Iodine Enhancement on Spectral CT in Acute Myocarditis. JACC Cardiovasc Imaging. 2017 Jul;10(7):826-827. doi: 10.1016/j.jcmg.2016.09.013. Epub 2016 Dec 21. No abstract available.</citation>
      <PMID>28017385</PMID>
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      <citation>Zhao L, Ma X, Delano MC, Jiang T, Zhang C, Liu Y, Zhang Z. Assessment of myocardial fibrosis and coronary arteries in hypertrophic cardiomyopathy using combined arterial and delayed enhanced CT: comparison with MR and coronary angiography. Eur Radiol. 2013 Apr;23(4):1034-43. doi: 10.1007/s00330-012-2674-0. Epub 2012 Oct 14.</citation>
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      <PMID>29989514</PMID>
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      <PMID>28382537</PMID>
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      <PMID>30343092</PMID>
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      <PMID>36916015</PMID>
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    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>IRCCS San Raffaele</investigator_affiliation>
      <investigator_full_name>Antonio Esposito</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiomyopathies</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/NCT06029400
  org study id: CTMyoC
  nct id: NCT06029400
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The identification of myocardial fibrosis in term of myocardial scar and extracellular matrix
        remodelling assessed respectively with the technique of Late Gadolinium Enhancement (LGE) and
        with the quantification of the Extracellular Volume Fraction (ECV) in Cardiac Magnetic
        Resonance has been demonstrated to be crucial in the diagnosis of different cardiomyopathy
        and to be prognosticators of major cardiovascular adverse events [1-14].
  
        For these reason CMR represent the gold standard for the non-invasive characterization of
        myocardial tissue in the clinical practice.
  
        However, regardless of its indisputable clinical role, CMR has many limitations: 1) it does
        not allow to evaluate coronary arteries; 2) it is contraindicated in patients with cardiac
        devices, and in case of conditional device they may also significantly impair LGE
        assessability due to artefacts [19]); 2) has limited availability and it is time consuming,
        therefore it is difficult to perform in the acute setting also because of poor patient
        compliance; 3) it is not feasible in patients suffering from claustrophobia. Cardiac Computed
        Tomography (cCT) is the image of choice to non-invasively study coronary arteries, not
        assessable with CMR. Moreover the recent technological advancement has continuously increased
        the clinical indication to the evaluation of cardiac valve and fibrosis, with reduced
        acquisition time respect to CMR (few minutes vs 1 hour), radiation exposure and costs.
  
        cCT has emerging as a possible alternative to CMR in the characterization of myocardial scar
        and extracellular volume fraction, with the advantage of a single shot evaluation of coronary
        arteries and myocardial tissue remodelling (scar, diffuse fibrosis, contractility..).In
        particular, several studies including some from our group, have demonstrated the clinical
        utility of myocardial tissue characterization with cCT in different clinical settings, such
        as myocardial infarction [20, 21], myocarditis [22], hypertrophic cardiomyopathy (HCM) [23],
        heart failure [24], ventricular tachycardia [25], and sarcoidosis [26]. Despite the
        interesting results, all these previous studies are limited on highly selected and small
        sample size. Moreover, any large study with long term follow-up is available in the setting
        of tissue characterization (myocardial scar and ECV) in cCT also as well as combined with a
        multiparametric approach (cardiac chamber morphofuntionality,contractility-strain, valve
        calcification, geometry, coronary atherosclerosis, myocardial perfusion, myocardial strain
        and texture) and no data are available about its prognostic impact. Aim of the study is to
        evaluate the potential of cCT in tissue characterization (myocardial scar and ECV) alone and
        associate to other CT imaging biomarker on a large population of patient clinically candidate
        to cardiac CT.
  observational model: Cohort
  time perspective: Other
  measure: Composite outcome
  time frame: 60 months
  description: first hospitalization for heart failure (HHF) or death (all-cause mortality).
  arm group label: Retrospective cohort
  description: The retrospective arm of the study will include 200 patients meeting the inclusion criteria who have received a cardiac CT from January 2013 to date of approval amendment. (2013 was chosen as starting year to retrieve CT and clinical date in order to have at least 5 years of follow-up per patients).
  arm group label: Prospective cohort
  description: The prospective arm of the study will include 2000 consecutive patients meeting the inclusion criteria, candidate to cardiac CT along the 7 years after date of approval.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Antonio Esposito
  phone: 02 2643 6102
  email: esposito.antonio@hsr.it
  last name: Anna Palmisano
  email: palmisano.anna@hsr.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
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  PMID: 36916015
  responsible party type: Principal Investigator
  investigator affiliation: IRCCS San Raffaele
  investigator full name: Antonio Esposito
  investigator title: Professor
  mesh term: Cardiomyopathies
  sharing ipd: No