<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/NCT03263728</url>
  </required_header>
  <id_info>
    <org_study_id>UW-17-168</org_study_id>
    <nct_id>NCT03263728</nct_id>
  </id_info>
  <brief_title>Cardiac Magnetic Resonance for Asymptomatic Type 2 Diabetics With Cardiovascular High Risk (CATCH) - Pilot Study</brief_title>
  <acronym>CATCH</acronym>
  <official_title>Cardiac Magnetic Resonance for Asymptomatic Type 2 Diabetics With Cardiovascular High Risk (CATCH) - Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Radiological Society of North America</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Hong Kong</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 aim of this study is to determine the prevalence of myocardial ischaemia in asymptomatic&#xD;
      high risk type 2 diabetic patients using stress cardiac MR and how many stress cardiac MR&#xD;
      examinations are false positive.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Asymptomatic coronary artery disease (CAD) is highly prevalent (ie. 17-59%) in type 2&#xD;
      diabetic patients. In addition, cardiovascular disease remains the most common cause of death&#xD;
      in type 2 diabetics. Previous trials using coronary computed tomography angiograms (CCTA) or&#xD;
      nuclear myocardial perfusion imaging (MPI) to screen for asymptomatic coronary artery disease&#xD;
      requiring intervention have been unsuccessful at reducing cardiovascular and all cause&#xD;
      mortality when compared to optimised medical therapy where cardiovascular risk factors are&#xD;
      treated in order to reduce cardiovascular complications. Possible reasons for this include,&#xD;
      the choice of imaging modality, the intervention chosen (eg. bare metal stents vs drug&#xD;
      eluting stents), patient cohort (eg. all diabetics vs high risk diabetics). Stress cardiac&#xD;
      magnetic resonance (CMR) is ideally suited to assess this group of high risk patients as&#xD;
      there is no radiation exposure and it allows a more complete analysis of the heart including&#xD;
      the assessment of myocardial viability, cardiac systolic and diastolic function. The&#xD;
      significance of this envisioned randomised controlled trial is firstly to investigate if&#xD;
      stress CMR screening will reduce major adverse cardiovascular events including death.&#xD;
      Secondly, a study using stress CMR has never been performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2017</start_date>
  <completion_date type="Actual">January 29, 2019</completion_date>
  <primary_completion_date type="Actual">January 29, 2019</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>Prevalence of myocardial ischaemia</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of myocardial infarction</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical predictors of silent ischaemia</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiovascular events</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Stress Cardiac MR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Cardiac Magnetic Resonance</intervention_name>
    <description>Screening of asymptomatic of high risk type 2 diabetic mellitus patients with stress cardiac magnetic resonance</description>
    <arm_group_label>Stress Cardiac MR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Onset of type 2 diabetes at ≥30yrs old with no history of ketoacidosis&#xD;
&#xD;
          -  60-80yrs old&#xD;
&#xD;
          -  Framingham Risk Score ≥20%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Angina pectoris or chest discomfort&#xD;
&#xD;
          -  Stress test or coronary angiography within 2 years&#xD;
&#xD;
          -  Previous myocardial infarction (MI)&#xD;
&#xD;
          -  Previous coronary artery stenting or coronary artery bypass grafting&#xD;
&#xD;
          -  Any clinical indication or contraindication for stress testing&#xD;
&#xD;
          -  Any contraindication to stress CMR (eg. non-MRI compatible devices)&#xD;
&#xD;
          -  Contraindication to gadolinium based contrast agent (eg. Renal impairment with an&#xD;
             estimated glomerular filtration rate (GFR) &lt;30ml/min/1.73m2)&#xD;
&#xD;
          -  Life expectancy &lt;2 years due to cancer or liver disease&#xD;
&#xD;
          -  Contraindication to dual antiplatelet therapy&#xD;
&#xD;
          -  Planned need for concomitant cardiac surgery&#xD;
&#xD;
          -  Refusal or inability to sign an informed consent.&#xD;
&#xD;
          -  Potential for non-compliance towards the requirements in the trial protocol&#xD;
&#xD;
          -  Unable to cover the costs of percutaneous coronary intervention (PCI) whether through&#xD;
             government subsidies, etc&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</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 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stress Cardiac Magnetic Resonance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <!-- 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/NCT03263728
org study id: UW-17-168
nct id: NCT03263728
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to determine the prevalence of myocardial ischaemia in asymptomatic
      high risk type 2 diabetic patients using stress cardiac MR and how many stress cardiac MR
      examinations are false positive.
Asymptomatic coronary artery disease (CAD) is highly prevalent (ie. 17-59%) in type 2
      diabetic patients. In addition, cardiovascular disease remains the most common cause of death
      in type 2 diabetics. Previous trials using coronary computed tomography angiograms (CCTA) or
      nuclear myocardial perfusion imaging (MPI) to screen for asymptomatic coronary artery disease
      requiring intervention have been unsuccessful at reducing cardiovascular and all cause
      mortality when compared to optimised medical therapy where cardiovascular risk factors are
      treated in order to reduce cardiovascular complications. Possible reasons for this include,
      the choice of imaging modality, the intervention chosen (eg. bare metal stents vs drug
      eluting stents), patient cohort (eg. all diabetics vs high risk diabetics). Stress cardiac
      magnetic resonance (CMR) is ideally suited to assess this group of high risk patients as
      there is no radiation exposure and it allows a more complete analysis of the heart including
      the assessment of myocardial viability, cardiac systolic and diastolic function. The
      significance of this envisioned randomised controlled trial is firstly to investigate if
      stress CMR screening will reduce major adverse cardiovascular events including death.
      Secondly, a study using stress CMR has never been performed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Prevalence of myocardial ischaemia
time frame: 1 year
measure: Prevalence of myocardial infarction
time frame: 1 year
measure: Clinical predictors of silent ischaemia
time frame: 1 year
measure: Major adverse cardiovascular events
time frame: 1 year
arm group label: Stress Cardiac MR
arm group type: Experimental
intervention type: Diagnostic Test
intervention name: Cardiac Magnetic Resonance
description: Screening of asymptomatic of high risk type 2 diabetic mellitus patients with stress cardiac magnetic resonance
arm group label: Stress Cardiac MR
criteria: 
gender: All
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Hong Kong
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Diabetes Mellitus, Type 2