<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/NCT04444128</url>
  </required_header>
  <id_info>
    <org_study_id>IMPReSSION Study</org_study_id>
    <nct_id>NCT04444128</nct_id>
  </id_info>
  <brief_title>IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION</brief_title>
  <acronym>IMPReSSION</acronym>
  <official_title>IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION</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>
    <collaborator>
      <agency>University Hospital Ulm</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>
      Magnetic properties of myocardial tissue change in the presence of disease. This is&#xD;
      detectable in the change of rate of magnetic relaxation, and measurable by T1 and T2 mapping&#xD;
      using cardiovascular magnetic resonance (CMR). These markers provide novel quantifiable&#xD;
      imaging measures for myocardial tissue characterisation. Despite similar principles, the&#xD;
      measurements differ considerably between different sequences, vendors and field strengths,&#xD;
      yielding a necessity to establish robust sequence-specific normal ranges, diagnostic&#xD;
      accuracy, relationships with clinical characteristics, cardiovascular risk factors, routine&#xD;
      cardiac imaging parameters, and prognosis. A further unknown relates to separation between&#xD;
      healthy myocardium and subclinical disease in subgroups of patients with suspected cardiac&#xD;
      involvement. Examples include patients with possible inflammation, such as in patients with a&#xD;
      recent COVID-19 infection or vaccination. Anticipated recruitment of a total of 3000&#xD;
      subjects, with 1500 subjects per field strength (1.5 and 3.0 Tesla).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 15, 2016</start_date>
  <completion_date type="Anticipated">June 30, 2030</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2030</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>1 year</time_frame>
    <description>number of deaths</description>
  </primary_outcome>
  <primary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>5 years</time_frame>
    <description>number of deaths</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart Failure Outcome</measure>
    <time_frame>1 year and 5 years</time_frame>
    <description>Number of participants with events including death due to heart failure and and hospitalisation due to Heart Failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular Outcome</measure>
    <time_frame>1 year and 5 years</time_frame>
    <description>Number of participants with death due to myocardial infarction, heart failure, arrhythmia or vascular events (pulmonary embolism, aortic dissection, stroke)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arrhythmia Outcome</measure>
    <time_frame>1 year and 5 years</time_frame>
    <description>Number of participants with documented events including sudden cardiac death, appropriate ICD discharge, sustained VT</description>
  </secondary_outcome>
  <enrollment type="Anticipated">6000</enrollment>
  <condition>Myocarditis</condition>
  <condition>Heart Failure</condition>
  <condition>Myocardial Fibrosis</condition>
  <condition>Vascular Inflammation</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Cardiac Imaging</intervention_name>
    <description>Subjects undergo CMR study with contrast agent (gadobutrol 0.1 mmol/kg; mapping, volumes, function, strain and LGE); transthoracic echocardiography and blood testing.</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Participants are consecutive asymptomatic healthy subjects or patients from subgroups with&#xD;
        known high risk (such as a recent COVID19 infection) with no known or clinically relevant&#xD;
        cardiac disease or currently prescribed cardiac medication.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Able to provide informed consent&#xD;
&#xD;
          2. 18 years of age and over&#xD;
&#xD;
          3. Absence of a valid clinical indication for CMR, and/or known or clinically relevant&#xD;
             cardiac disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  accepted contraindications for a contrast-enhanced CMR study (in line with MRI safety&#xD;
             and SmPC for contrast agent)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kerckhoff Hospital</name>
      <address>
        <city>Bad Nauheim</city>
        <state>Hessen</state>
        <zip>61231</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Frankfurt</name>
      <address>
        <city>Frankfurt</city>
        <state>Hessen</state>
        <zip>Frankfurt am Main</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Mainz</name>
      <address>
        <city>Mainz</city>
        <state>Hessen</state>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.cardiac-imaging.org/impression-study.html</url>
    <description>Related Info</description>
  </link>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>December 13, 2022</last_update_submitted>
  <last_update_submitted_qc>December 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2022</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>Priv Doz Dr Dr</investigator_title>
  </responsible_party>
  <keyword>Inflammation</keyword>
  <keyword>Remodeling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocarditis</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04444128
org study id: IMPReSSION Study
nct id: NCT04444128
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Magnetic properties of myocardial tissue change in the presence of disease. This is
      detectable in the change of rate of magnetic relaxation, and measurable by T1 and T2 mapping
      using cardiovascular magnetic resonance (CMR). These markers provide novel quantifiable
      imaging measures for myocardial tissue characterisation. Despite similar principles, the
      measurements differ considerably between different sequences, vendors and field strengths,
      yielding a necessity to establish robust sequence-specific normal ranges, diagnostic
      accuracy, relationships with clinical characteristics, cardiovascular risk factors, routine
      cardiac imaging parameters, and prognosis. A further unknown relates to separation between
      healthy myocardium and subclinical disease in subgroups of patients with suspected cardiac
      involvement. Examples include patients with possible inflammation, such as in patients with a
      recent COVID-19 infection or vaccination. Anticipated recruitment of a total of 3000
      subjects, with 1500 subjects per field strength (1.5 and 3.0 Tesla).
observational model: Cohort
time perspective: Prospective
measure: All-cause mortality
time frame: 1 year
description: number of deaths
measure: All-cause mortality
time frame: 5 years
description: number of deaths
measure: Heart Failure Outcome
time frame: 1 year and 5 years
description: Number of participants with events including death due to heart failure and and hospitalisation due to Heart Failure
measure: Cardiovascular Outcome
time frame: 1 year and 5 years
description: Number of participants with death due to myocardial infarction, heart failure, arrhythmia or vascular events (pulmonary embolism, aortic dissection, stroke)
measure: Arrhythmia Outcome
time frame: 1 year and 5 years
description: Number of participants with documented events including sudden cardiac death, appropriate ICD discharge, sustained VT
intervention type: Diagnostic Test
intervention name: Cardiac Imaging
description: Subjects undergo CMR study with contrast agent (gadobutrol 0.1 mmol/kg; mapping, volumes, function, strain and LGE); transthoracic echocardiography and blood testing.
Blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: Germany
url: http://www.cardiac-imaging.org/impression-study.html
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Johann Wolfgang Goethe University Hospital
investigator full name: Valentina Puentmann
investigator title: Priv Doz Dr Dr
mesh term: Myocarditis
mesh term: Inflammation
sharing ipd: No