<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/NCT03798652</url>
  </required_header>
  <id_info>
    <org_study_id>247309</org_study_id>
    <nct_id>NCT03798652</nct_id>
  </id_info>
  <brief_title>Improved Prediction of Functional Recovery After Revascularisation Using Combined Assessment of Myocardial Ischaemia and Viability by CMR - Pilot Study</brief_title>
  <official_title>Improved Prediction of Functional Recovery After Revascularisation Using Combined Assessment of Myocardial Ischaemia and Viability by CMR - Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King's College London</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 study will investigate whether a new high resolution heart Magnetic Resonance Imaging&#xD;
      scan, combining assessment of ischemia and viability by perfusion and Late Gadolinium&#xD;
      Enhancement -Cardiac Magnetic Resonance is superior to Late Gadolinium Enhacement imaging&#xD;
      alone in predicting functional recovery following revascularisation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronary artery disease, where the heart's blood supply is restricted by narrowings or&#xD;
      blockages, is the commonest cause of heart failure. This condition is called ischaemic&#xD;
      cardiomyopathy. In some patients, treating these narrowings/ blockages with by-pass surgery&#xD;
      or stents, known as &quot;revascularisation&quot;, helps improve the pumping strength of the heart but&#xD;
      it is currently difficult to predict which patients will benefit. The best test the&#xD;
      investigators currently have to predict who will benefit from revascularisation is an&#xD;
      Magnetic Resonance Imaging scan of the heart which looks for how much the heart has been&#xD;
      scarred. Hearts with no scar usually improve after revascularisation and hearts with lots of&#xD;
      scar usually do not. However, lots of patients fall into the middle and have moderate amounts&#xD;
      of scar. The Magnetic Resonance Imaging scan isn't good at predicting if this group of&#xD;
      patients will benefit from revascularisation. Revascularisation procedures, including heart&#xD;
      by-passes, are not without risk and often require time in intensive care, several days in&#xD;
      hospital and a long recovery period at home. If the investigators can develop a better test&#xD;
      which is more accurate at predicting whether hearts with moderate scar will improve then they&#xD;
      will be able to provide better care for patients by ensuring only those patients who will get&#xD;
      benefit from revascularisation are put through the procedure.&#xD;
&#xD;
      This study will investigate whether a new high-resolution heart Magnetic Resonance Imaging&#xD;
      scan, which looks at not only levels of scar but also the quality of blood supply, is more&#xD;
      accurate than current MRI scans at predicting heart recovery after revascularisation in&#xD;
      patients with moderate amounts of scar.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 3, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>Recovery of the regional systolic function</measure>
    <time_frame>12 months</time_frame>
    <description>Recovery will be defined as a reduction in average resting wall motion score equal or more than 1. The region of interest will be defined as the segments of myocardium subentended by the revascularised coronary stenosis.&#xD;
Segments will be considered to have been revascularised if surgical by-pass to the diseased coronary artery subtending the segment is considered successful by the surgical team at the time of surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recovery of overall Left Ventricular ejection fraction</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Left Ventricular end diastolic volume</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Composite of all cause death hospitalisation for heart failure</measure>
    <time_frame>12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>6- minute walk test</measure>
    <time_frame>12 months</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">56</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Ischemic Cardiomyopathy</condition>
  <condition>Cardiac Ischemia</condition>
  <arm_group>
    <arm_group_label>Patients referred for CABG</arm_group_label>
    <description>Patients with known coronary artery disease referred for isolated surgical revascularisation, who will be invited to attend our facility for a research CMR scan, a research 3D transthoracic echocardiogram and a 6 minute walk test</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Research CMR scan</intervention_name>
    <description>CMR scanning at a 3Tesla scanner at King's College London</description>
    <arm_group_label>Patients referred for CABG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Research 3D transthoracic echocardiogram</intervention_name>
    <description>The scan is required to assess left ventricular systolic function</description>
    <arm_group_label>Patients referred for CABG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>6-minute walk test</intervention_name>
    <description>Sub maximal exercise that provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.</description>
    <arm_group_label>Patients referred for CABG</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patient will all the above inclusion criteria and none of the exclusion criteria will&#xD;
        be identified from:&#xD;
&#xD;
          -  Referrals for cardiac MRI scans at King's College London;&#xD;
&#xD;
          -  Referrals for cardiac catheterisation at St. Thomas' Hospital;&#xD;
&#xD;
          -  Outpatient clinic referrals to St. Thomas's Hospital cardiovascular services;&#xD;
&#xD;
          -  Cardiovascular multi-disciolinary team meetings&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Known coronary artery disease referred for isolated surgical revascularisation;&#xD;
&#xD;
          2. Wall motion abnormalities at rest in at least two adjacents segments on standard AHA&#xD;
             model supplied by a diseased coronary artery;&#xD;
&#xD;
          3. LV EF &lt;45%.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contraindications to CMR, adenosine and low-dose dobutamine;&#xD;
&#xD;
          2. GFR &lt;30 ml/min&#xD;
&#xD;
          3. Decompensated heart failure requiring inotropic support, invasive or non-invasive&#xD;
             ventilation or Intra-aortic Ballon Pump/left ventricular assist device therapy &lt; 72&#xD;
             hours prior to enrolment;&#xD;
&#xD;
          4. Sustained Ventricular Tachycardia/Ventricular Fibrillation&lt;72 hours prior to&#xD;
             enrolment;&#xD;
&#xD;
          5. Implantable Cardioverter Defibrilator;&#xD;
&#xD;
          6. Pregnancy;&#xD;
&#xD;
          7. Age&lt;18 years&#xD;
&#xD;
          8. Previous established diagnosis of non ischaemic cardiomyopathy;&#xD;
&#xD;
          9. Severe concomitant valvular disease;&#xD;
&#xD;
         10. Recente acute coronary syndrome(&lt;4 weeks prior to enrolment).&#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>Amedeo Chiribiri, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>King's College London</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amedeo Chiribiri, Dr</last_name>
    <phone>+44 (0)2071887188</phone>
    <email>Amedeo.Chiribiri@kcl.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Russell Franks, Dr</last_name>
    <email>Russell.Franks@kcl.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>King's College London</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amedeo Chiribiri, Dr</last_name>
      <phone>+44 (0)2071887188</phone>
      <email>Amedeo.Chiribiri@kcl.ac.uk</email>
    </contact>
    <contact_backup>
      <last_name>Russell Franks, Dr</last_name>
      <phone>+44 (0)2071887188</phone>
      <email>russell.franks@kcl.ac.uk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>August 16, 2019</last_update_submitted>
  <last_update_submitted_qc>August 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Perfusion</keyword>
  <keyword>Viability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Cardiomyopathies</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Ischemia</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/NCT03798652
org study id: 247309
nct id: NCT03798652
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will investigate whether a new high resolution heart Magnetic Resonance Imaging
      scan, combining assessment of ischemia and viability by perfusion and Late Gadolinium
      Enhancement -Cardiac Magnetic Resonance is superior to Late Gadolinium Enhacement imaging
      alone in predicting functional recovery following revascularisation.
Coronary artery disease, where the heart's blood supply is restricted by narrowings or
      blockages, is the commonest cause of heart failure. This condition is called ischaemic
      cardiomyopathy. In some patients, treating these narrowings/ blockages with by-pass surgery
      or stents, known as "revascularisation", helps improve the pumping strength of the heart but
      it is currently difficult to predict which patients will benefit. The best test the
      investigators currently have to predict who will benefit from revascularisation is an
      Magnetic Resonance Imaging scan of the heart which looks for how much the heart has been
      scarred. Hearts with no scar usually improve after revascularisation and hearts with lots of
      scar usually do not. However, lots of patients fall into the middle and have moderate amounts
      of scar. The Magnetic Resonance Imaging scan isn't good at predicting if this group of
      patients will benefit from revascularisation. Revascularisation procedures, including heart
      by-passes, are not without risk and often require time in intensive care, several days in
      hospital and a long recovery period at home. If the investigators can develop a better test
      which is more accurate at predicting whether hearts with moderate scar will improve then they
      will be able to provide better care for patients by ensuring only those patients who will get
      benefit from revascularisation are put through the procedure.

      This study will investigate whether a new high-resolution heart Magnetic Resonance Imaging
      scan, which looks at not only levels of scar but also the quality of blood supply, is more
      accurate than current MRI scans at predicting heart recovery after revascularisation in
      patients with moderate amounts of scar.
observational model: Cohort
time perspective: Other
measure: Recovery of the regional systolic function
time frame: 12 months
description: Recovery will be defined as a reduction in average resting wall motion score equal or more than 1. The region of interest will be defined as the segments of myocardium subentended by the revascularised coronary stenosis.
Segments will be considered to have been revascularised if surgical by-pass to the diseased coronary artery subtending the segment is considered successful by the surgical team at the time of surgery.
measure: Recovery of overall Left Ventricular ejection fraction
time frame: 12 months
measure: Change in Left Ventricular end diastolic volume
time frame: 12 months
measure: Composite of all cause death hospitalisation for heart failure
time frame: 12 months
measure: 6- minute walk test
time frame: 12 months
arm group label: Patients referred for CABG
description: Patients with known coronary artery disease referred for isolated surgical revascularisation, who will be invited to attend our facility for a research CMR scan, a research 3D transthoracic echocardiogram and a 6 minute walk test
intervention type: Device
intervention name: Research CMR scan
description: CMR scanning at a 3Tesla scanner at King's College London
arm group label: Patients referred for CABG
intervention type: Device
intervention name: Research 3D transthoracic echocardiogram
description: The scan is required to assess left ventricular systolic function
arm group label: Patients referred for CABG
intervention type: Other
intervention name: 6-minute walk test
description: Sub maximal exercise that provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
arm group label: Patients referred for CABG
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Amedeo Chiribiri, Dr
role: Principal Investigator
affiliation: King's College London
last name: Amedeo Chiribiri, Dr
phone: +44 (0)2071887188
email: Amedeo.Chiribiri@kcl.ac.uk
last name: Russell Franks, Dr
email: Russell.Franks@kcl.ac.uk
facility: 
status: Recruiting
contact: 
contact backup: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Cardiomyopathies
mesh term: Myocardial Ischemia
mesh term: Coronary Artery Disease
mesh term: Ischemia
sharing ipd: Undecided