<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/NCT03749343</url>
  </required_header>
  <id_info>
    <org_study_id>T1 Outcome 1/16gA</org_study_id>
    <nct_id>NCT03749343</nct_id>
  </id_info>
  <brief_title>International T1 Multicenter Outcome Study</brief_title>
  <acronym>T1Outcome-DE</acronym>
  <official_title>International T1 Multicenter Outcome Study (the German Chapter)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johann Wolfgang Goethe University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kerckhoff Klinik</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johannes Gutenberg University Mainz</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johann Wolfgang Goethe University Hospital</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>
      Mapping of magnetic relaxation within the myocardial tissue using T1 (and T2) mapping using&#xD;
      cardiovascular magnetic resonance (CMR) are novel measures of quantifiable (scalable)&#xD;
      myocardial tissue characterisation. Evidence suggests that myocardial mapping could be useful&#xD;
      in detection of diffuse myocardial disease, complementing late gadolinium enhancement (LGE)&#xD;
      as the tool for regional myocardial disease. A handful of studies, three single centre study&#xD;
      of a single T1 index with outcomes and one multicentre study for all indices reported strong&#xD;
      associations with all cause mortality and heart failure. These studies were based on a&#xD;
      single-vendor platform and were using a single sequence. The main unknowns pertaining the&#xD;
      successful translation of this technique and the transferability of the methodology beyond a&#xD;
      single centre and lack of outcome evidence from broad and large populations. In this study,&#xD;
      we will assess the diagnostic accuracy of T1 (and T2) mapping measurements in health and&#xD;
      disease, and the prognostic relevance of T1 mapping measurements by associations with&#xD;
      outcome. This study is builds upon/integrates the evidence of the NCT02407197 study, which&#xD;
      remains active for follow-up, but is currently no longer recruiting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2016</start_date>
  <completion_date type="Anticipated">February 28, 2030</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2030</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Survival</measure>
    <time_frame>1 year</time_frame>
    <description>number of deaths</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Survival</measure>
    <time_frame>5 year</time_frame>
    <description>number of deaths</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Heart Failure events</measure>
    <time_frame>1 year</time_frame>
    <description>Number of participants with events including death and Hospitalisation due to Heart Failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Heart Failure events</measure>
    <time_frame>5 year</time_frame>
    <description>Number of participants with events including death and Hospitalisation due to Heart Failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Arrhythmia</measure>
    <time_frame>1 year</time_frame>
    <description>Number of participants with events of documented Sudden Cardiac Death, appropriate ICD discharge, sustained VT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Arrhythmia</measure>
    <time_frame>5 year</time_frame>
    <description>Number of participants with events including documented Sudden Cardiac Death, appropriate ICD discharge, sustained VT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of death due to to cardiovascular causes</measure>
    <time_frame>1 year</time_frame>
    <description>Number of participants with death due to myocardial infarction, heart failure, arrhythmia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of death due to to cardiovascular causes</measure>
    <time_frame>5 year</time_frame>
    <description>Number of participants with death due to myocardial infarction, heart failure, arrhythmia</description>
  </secondary_outcome>
  <enrollment type="Anticipated">8000</enrollment>
  <condition>Heart Failure</condition>
  <condition>Cardiomyopathies</condition>
  <condition>Inflammatory Disease</condition>
  <condition>Coronary Artery Disease</condition>
  <condition>Chronic Kidney Diseases</condition>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adults referred to clinical cardiac magnetic resonance imaging&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults (&gt;18 years of age)&#xD;
&#xD;
          2. Able to provide informed consent&#xD;
&#xD;
          3. Clinically indicated cardiac magnetic resonance imaging study&#xD;
&#xD;
        Exclusion Criteria: contraindications for clinical cardiac magnetic resonance imaging due&#xD;
        to MR unsafe devices or objects&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Valentina Puentmann, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Goethe University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Valentina O Puentmann, MD, PhD</last_name>
    <email>cvi-research@kgu.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Franziska Weis</last_name>
    <email>cvi-research@kgu.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kerckhoff Hospital</name>
      <address>
        <city>Bad Nauheim</city>
        <state>Hessen</state>
        <zip>61231</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andreas Rolf</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institute for experimental and translational cardiovascular imaging</name>
      <address>
        <city>Frankfurt Am Main</city>
        <state>Hessen</state>
        <zip>60596</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Valentina Puentmann, MD, PhD</last_name>
      <email>cvi-research@kgu.de</email>
    </contact>
    <contact_backup>
      <last_name>Franziska Weis</last_name>
      <email>cvi-research@kgu.de</email>
    </contact_backup>
    <investigator>
      <last_name>Eike Nagel, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital Mainz</name>
      <address>
        <city>Mainz</city>
        <state>Hessen</state>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tilman Emrich, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <results_reference>
    <citation>Puntmann VO, Carr-White G, Jabbour A, Yu CY, Gebker R, Kelle S, Rolf A, Zitzmann S, Peker E, D'Angelo T, Pathan F, Elen, Valbuena S, Hinojar R, Arendt C, Narula J, Herrmann E, Zeiher AM, Nagel E; International T1 Multicentre CMR Outcome Study. Native T1 and ECV of Noninfarcted Myocardium and Outcome in Patients With Coronary Artery Disease. J Am Coll Cardiol. 2018 Feb 20;71(7):766-778. doi: 10.1016/j.jacc.2017.12.020.</citation>
    <PMID>29447739</PMID>
  </results_reference>
  <results_reference>
    <citation>Winau L, Hinojar Baydes R, Braner A, Drott U, Burkhardt H, Sangle S, D'Cruz DP, Carr-White G, Marber M, Schnoes K, Arendt C, Klingel K, Vogl TJ, Zeiher AM, Nagel E, Puntmann VO. High-sensitive troponin is associated with subclinical imaging biosignature of inflammatory cardiovascular involvement in systemic lupus erythematosus. Ann Rheum Dis. 2018 Nov;77(11):1590-1598. doi: 10.1136/annrheumdis-2018-213661. Epub 2018 Aug 4.</citation>
    <PMID>30077990</PMID>
  </results_reference>
  <results_reference>
    <citation>Haslbauer JD, Lindner S, Valbuena-Lopez S, Zainal H, Zhou H, D'Angelo T, Pathan F, Arendt CA, Bug G, Serve H, Vogl TJ, Zeiher AM, Carr-White G, Nagel E, Puntmann VO. CMR imaging biosignature of cardiac involvement due to cancer-related treatment by T1 and T2 mapping. Int J Cardiol. 2019 Jan 15;275:179-186. doi: 10.1016/j.ijcard.2018.10.023. Epub 2018 Oct 11.</citation>
    <PMID>30360992</PMID>
  </results_reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>July 12, 2023</last_update_submitted>
  <last_update_submitted_qc>July 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johann Wolfgang Goethe University Hospital</investigator_affiliation>
    <investigator_full_name>Valentina Puentmann</investigator_full_name>
    <investigator_title>Principal Investigator, Clinical professor</investigator_title>
  </responsible_party>
  <keyword>T1 mapping</keyword>
  <keyword>native T1</keyword>
  <keyword>native T2</keyword>
  <keyword>accuracy</keyword>
  <keyword>prognosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Cardiomyopathies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03749343
org study id: T1 Outcome 1/16gA
nct id: NCT03749343
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Mapping of magnetic relaxation within the myocardial tissue using T1 (and T2) mapping using
      cardiovascular magnetic resonance (CMR) are novel measures of quantifiable (scalable)
      myocardial tissue characterisation. Evidence suggests that myocardial mapping could be useful
      in detection of diffuse myocardial disease, complementing late gadolinium enhancement (LGE)
      as the tool for regional myocardial disease. A handful of studies, three single centre study
      of a single T1 index with outcomes and one multicentre study for all indices reported strong
      associations with all cause mortality and heart failure. These studies were based on a
      single-vendor platform and were using a single sequence. The main unknowns pertaining the
      successful translation of this technique and the transferability of the methodology beyond a
      single centre and lack of outcome evidence from broad and large populations. In this study,
      we will assess the diagnostic accuracy of T1 (and T2) mapping measurements in health and
      disease, and the prognostic relevance of T1 mapping measurements by associations with
      outcome. This study is builds upon/integrates the evidence of the NCT02407197 study, which
      remains active for follow-up, but is currently no longer recruiting.
observational model: Cohort
time perspective: Prospective
measure: Survival
time frame: 1 year
description: number of deaths
measure: Survival
time frame: 5 year
description: number of deaths
measure: Rate of Heart Failure events
time frame: 1 year
description: Number of participants with events including death and Hospitalisation due to Heart Failure
measure: Rate of Heart Failure events
time frame: 5 year
description: Number of participants with events including death and Hospitalisation due to Heart Failure
measure: Rate of Arrhythmia
time frame: 1 year
description: Number of participants with events of documented Sudden Cardiac Death, appropriate ICD discharge, sustained VT
measure: Rate of Arrhythmia
time frame: 5 year
description: Number of participants with events including documented Sudden Cardiac Death, appropriate ICD discharge, sustained VT
measure: Rate of death due to to cardiovascular causes
time frame: 1 year
description: Number of participants with death due to myocardial infarction, heart failure, arrhythmia
measure: Rate of death due to to cardiovascular causes
time frame: 5 year
description: Number of participants with death due to myocardial infarction, heart failure, arrhythmia
Blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Valentina Puentmann, MD, PhD
role: Principal Investigator
affiliation: Goethe University
last name: Valentina O Puentmann, MD, PhD
email: cvi-research@kgu.de
last name: Franziska Weis
email: cvi-research@kgu.de
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
country: Germany
citation: Puntmann VO, Carr-White G, Jabbour A, Yu CY, Gebker R, Kelle S, Rolf A, Zitzmann S, Peker E, D'Angelo T, Pathan F, Elen, Valbuena S, Hinojar R, Arendt C, Narula J, Herrmann E, Zeiher AM, Nagel E; International T1 Multicentre CMR Outcome Study. Native T1 and ECV of Noninfarcted Myocardium and Outcome in Patients With Coronary Artery Disease. J Am Coll Cardiol. 2018 Feb 20;71(7):766-778. doi: 10.1016/j.jacc.2017.12.020.
PMID: 29447739
citation: Winau L, Hinojar Baydes R, Braner A, Drott U, Burkhardt H, Sangle S, D'Cruz DP, Carr-White G, Marber M, Schnoes K, Arendt C, Klingel K, Vogl TJ, Zeiher AM, Nagel E, Puntmann VO. High-sensitive troponin is associated with subclinical imaging biosignature of inflammatory cardiovascular involvement in systemic lupus erythematosus. Ann Rheum Dis. 2018 Nov;77(11):1590-1598. doi: 10.1136/annrheumdis-2018-213661. Epub 2018 Aug 4.
PMID: 30077990
citation: Haslbauer JD, Lindner S, Valbuena-Lopez S, Zainal H, Zhou H, D'Angelo T, Pathan F, Arendt CA, Bug G, Serve H, Vogl TJ, Zeiher AM, Carr-White G, Nagel E, Puntmann VO. CMR imaging biosignature of cardiac involvement due to cancer-related treatment by T1 and T2 mapping. Int J Cardiol. 2019 Jan 15;275:179-186. doi: 10.1016/j.ijcard.2018.10.023. Epub 2018 Oct 11.
PMID: 30360992
responsible party type: Principal Investigator
investigator affiliation: Johann Wolfgang Goethe University Hospital
investigator full name: Valentina Puentmann
investigator title: Principal Investigator, Clinical professor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Coronary Artery Disease
mesh term: Cardiomyopathies
sharing ipd: Undecided