<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/NCT03040947</url>
  </required_header>
  <id_info>
    <org_study_id>2016/2050</org_study_id>
    <nct_id>NCT03040947</nct_id>
  </id_info>
  <brief_title>MRI Sequence and Imaging Protocol Development</brief_title>
  <acronym>BikeMRI</acronym>
  <official_title>MRI Sequence and Imaging Protocol Development</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Heart Centre Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Heart Centre Singapore</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 purpose of this study is to develop imaging protocols when using cardiovascular magnetic&#xD;
      resonance (CMR) to assess cardiac functions, morphology and tissue characterization. The&#xD;
      National Heart Research Institute Singapore (NHRIS) houses two dedicated CMR scanners to&#xD;
      support the numerous investigator initiated projects in patients with various cardiac&#xD;
      pathologists. By optimizing novel CMR sequences used in these studies, scanning time can be&#xD;
      shortened for patients with underlying cardiac diseases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In medical research, there is a continuous need to develop new imaging techniques such as&#xD;
      cardiovascular magnetic resonance (CMR) imaging. This will allow us to visualize and study&#xD;
      the function and structure of the heart in greater detail so as to improve the diagnosis and&#xD;
      treatment of patients with various cardiac conditions. The aim of the study is to optimise&#xD;
      new CMR sequences, allowing the development of imaging protocols in future research studies.&#xD;
&#xD;
      This study will hence recruit 800 subjects for each of the following sub-studies:&#xD;
&#xD;
        1. Sub-study 1: Normal CMR protocols for assessment of cardiac function and morphology&#xD;
&#xD;
        2. Sub-study 2: Exercise stress protocols with a CMR-compatible supine bike.&#xD;
&#xD;
      For the first sub-study, 400 healthy volunteers and patients with cardiac conditions or&#xD;
      suspected to have cardiac conditions will be recruited. The testing and optimising of CMR&#xD;
      sequence settings are crucial to ensure the accuracy and robustness of the scan before using&#xD;
      the scan as a clinical diagnostic tool.&#xD;
&#xD;
      For the second sub-study, 400 healthy volunteers of different fitness levels and and patients&#xD;
      with cardiac conditions or suspected to have cardiac conditions will be recruited. An&#xD;
      exercise stress protocol will then be developed for future studies in patients with suspected&#xD;
      coronary artery diseases. For this protocol, participants will be asked to cycle on a supine&#xD;
      exercise bike to assess the effects of exercise and free breathing on the stability of the&#xD;
      CMR imaging sequences.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2016</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>First occurrence of cardiovascular event</measure>
    <time_frame>1 day</time_frame>
    <description>This outcomes are obtained via hospital records or by a phone follow-up</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Cardiomyopathy, Hypertrophic</condition>
  <condition>Cardiomyopathy, Dilated</condition>
  <condition>Left Ventricular Hypertrophy</condition>
  <condition>Ischemic Heart Disease</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Healthy Volunteer</arm_group_label>
    <description>Healthy Volunteers will undergo a cardiovascular magnetic resonance imaging scan.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diseased (Suspected or Known Cardiac Conditions)</arm_group_label>
    <description>Patients will undergo a cardiovascular magnetic resonance imaging scan.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cardiovascular Magnetic Resonance</intervention_name>
    <arm_group_label>Diseased (Suspected or Known Cardiac Conditions)</arm_group_label>
    <arm_group_label>Healthy Volunteer</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples will be collected from all participants before and after the CMR scan.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Potential participants will be identified from an existing database of healthy volunteers&#xD;
        who had previously participated in the biobank program and indicated interest in future&#xD;
        studies.&#xD;
&#xD;
        Potential patients are identified from the imaging or admissions databases. The primary&#xD;
        physicians of these patients identified will be notified prior to recruitment and the&#xD;
        patient will only be recruited if the primary physician is agreeable.&#xD;
&#xD;
        Alternatively, other methods of participant identification include co-workers of the&#xD;
        department who volunteer themselves and indicate on the Informed Consent Document that&#xD;
        their participation was entirely voluntary and not under coercion.&#xD;
&#xD;
        Team members of this study are not eligible for participation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has no known significant medical history&#xD;
&#xD;
          -  Is able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has contraindications to CMR implantable devices, cerebral aneutysm clips and cochlear&#xD;
             implants&#xD;
&#xD;
          -  Has claustrophobia&#xD;
&#xD;
          -  Females who are pregnant&#xD;
&#xD;
          -  Is unable to comply with study protocols&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National Heart Centre Singapore</name>
      <address>
        <city>Singapore</city>
        <zip>169609</zip>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Terrance Chua, MBBS</last_name>
      <email>terrance.chua.s.j@singhealth.com.sg</email>
    </contact>
    <contact_backup>
      <last_name>Briana Ang, BSc</last_name>
      <phone>6704 2298</phone>
      <email>briana.ang.w.y@nhcs.com.sg</email>
    </contact_backup>
    <investigator>
      <last_name>Calvin Chin, MBBS, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Le Thu Thao, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <results_reference>
    <citation>Le TT, Bryant JA, Ting AE, Ho PY, Su B, Teo RC, Gan JS, Chung YC, O'Regan DP, Cook SA, Chin CW. Assessing exercise cardiac reserve using real-time cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2017 Jan 23;19(1):7. doi: 10.1186/s12968-017-0322-1.</citation>
    <PMID>28110638</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>March 2, 2021</last_update_submitted>
  <last_update_submitted_qc>March 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Cardiomyopathies</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Hypertrophy, Left Ventricular</mesh_term>
    <mesh_term>Cardiomyopathy, Dilated</mesh_term>
    <mesh_term>Cardiomyopathy, Hypertrophic</mesh_term>
    <mesh_term>Hypertrophy</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/NCT03040947
org study id: 2016/2050
nct id: NCT03040947
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to develop imaging protocols when using cardiovascular magnetic
      resonance (CMR) to assess cardiac functions, morphology and tissue characterization. The
      National Heart Research Institute Singapore (NHRIS) houses two dedicated CMR scanners to
      support the numerous investigator initiated projects in patients with various cardiac
      pathologists. By optimizing novel CMR sequences used in these studies, scanning time can be
      shortened for patients with underlying cardiac diseases.
In medical research, there is a continuous need to develop new imaging techniques such as
      cardiovascular magnetic resonance (CMR) imaging. This will allow us to visualize and study
      the function and structure of the heart in greater detail so as to improve the diagnosis and
      treatment of patients with various cardiac conditions. The aim of the study is to optimise
      new CMR sequences, allowing the development of imaging protocols in future research studies.

      This study will hence recruit 800 subjects for each of the following sub-studies:

        1. Sub-study 1: Normal CMR protocols for assessment of cardiac function and morphology

        2. Sub-study 2: Exercise stress protocols with a CMR-compatible supine bike.

      For the first sub-study, 400 healthy volunteers and patients with cardiac conditions or
      suspected to have cardiac conditions will be recruited. The testing and optimising of CMR
      sequence settings are crucial to ensure the accuracy and robustness of the scan before using
      the scan as a clinical diagnostic tool.

      For the second sub-study, 400 healthy volunteers of different fitness levels and and patients
      with cardiac conditions or suspected to have cardiac conditions will be recruited. An
      exercise stress protocol will then be developed for future studies in patients with suspected
      coronary artery diseases. For this protocol, participants will be asked to cycle on a supine
      exercise bike to assess the effects of exercise and free breathing on the stability of the
      CMR imaging sequences.
observational model: Cohort
time perspective: Prospective
measure: First occurrence of cardiovascular event
time frame: 1 day
description: This outcomes are obtained via hospital records or by a phone follow-up
arm group label: Healthy Volunteer
description: Healthy Volunteers will undergo a cardiovascular magnetic resonance imaging scan.
arm group label: Diseased (Suspected or Known Cardiac Conditions)
description: Patients will undergo a cardiovascular magnetic resonance imaging scan.
intervention type: Other
intervention name: Cardiovascular Magnetic Resonance
arm group label: Diseased (Suspected or Known Cardiac Conditions)
arm group label: Healthy Volunteer
Blood samples will be collected from all participants before and after the CMR scan.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Singapore
citation: Le TT, Bryant JA, Ting AE, Ho PY, Su B, Teo RC, Gan JS, Chung YC, O'Regan DP, Cook SA, Chin CW. Assessing exercise cardiac reserve using real-time cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2017 Jan 23;19(1):7. doi: 10.1186/s12968-017-0322-1.
PMID: 28110638
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Cardiomyopathies
mesh term: Myocardial Ischemia
mesh term: Coronary Artery Disease
mesh term: Hypertrophy, Left Ventricular
mesh term: Cardiomyopathy, Dilated
mesh term: Cardiomyopathy, Hypertrophic
mesh term: Hypertrophy
sharing ipd: No