<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/NCT04458883</url>
  </required_header>
  <id_info>
    <org_study_id>2-010-20</org_study_id>
    <nct_id>NCT04458883</nct_id>
  </id_info>
  <brief_title>The Next Leap in Cardiac Magnetic Resonance Imaging:Cycling the Field</brief_title>
  <acronym>TITAN</acronym>
  <official_title>The Next Leap in Cardiac Magnetic Resonance Imaging:Cycling the Field The TITAN Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aberdeen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aberdeen</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 main aim of the study is to build and test a cardiac-specific coil purposely assembled in&#xD;
      house to suit the FFC-MRI whole-body prototype and to test if it could be used for clinical&#xD;
      cardiac scans in human subject populations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aberdeen scientists are at the forefront of a new type of magnetic resonance imaging (MRI),&#xD;
      having built in-house the only two available prototypes of Fast Field-Cycling MRI in the&#xD;
      world - and these already have clinical imaging capabilities. Fast Field-Cycling MRI switches&#xD;
      rapidly over a range of field strengths (0.2 T to 200 µT), providing a T1 dispersion curve.&#xD;
      This information is invisible to fixed-field scanners and uncovers unique knowledge about&#xD;
      motion and interaction between component molecules within a tissue (i.e. water/fat/proteins).&#xD;
      In this application the investigators wish to use their in-house expertise further to extend&#xD;
      the capability of our Fast Field-Cycling MRI to perform cardiac imaging by building the&#xD;
      first-ever cardiac Fast Field-Cycling MRI coil and develop cardiac pulse sequences with ECG&#xD;
      gating. The investigators will aim to establish the normalcy of T1 dispersion curves for left&#xD;
      ventricular myocardium in healthy volunteers, and further on to distinguish the&#xD;
      characteristics of post-myocardial infarction scar T1 dispersion curves.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The main aim of the study is to build and test a cardiac-specific coil purposely assembled in house to suit the FFC-MRI whole-body prototype and to test if it could be used for clinical cardiac scans in human subject populations.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiac Magnetic Resonance Imaging</measure>
    <time_frame>At baseline</time_frame>
    <description>Cardiac Magnetic Resonance Imaging - Cardiac Scan to assess cardiac function and T1 dispersion curves</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fast Field Cycling Magnetic Resonance Imaging</measure>
    <time_frame>At baseline</time_frame>
    <description>Fast Field Cycling Magnetic Resonance Imaging - Cardiac Scan to assess cardiac function and T1 dispersion curves</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Myocardial Infarction Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients diagnosed with a myocardial infarction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy Volunteers</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cardiac Magnetic Resonance Imaging</intervention_name>
    <description>Cardiac Magnetic Resonance Imaging - Cardiac Scan</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Myocardial Infarction Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fast Field Cycling - Magnetic Resonance Imaging</intervention_name>
    <description>Fast Field Cycling - Magnetic Resonance Imaging Cardiac Scan</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Myocardial Infarction Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Electrocardiogram</intervention_name>
    <description>Electrocardiogram</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <other_name>ECG</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Echocardiogram</intervention_name>
    <description>Echocardiogram</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant who is willing and able to give informed consent for participation in the&#xD;
             study&#xD;
&#xD;
          -  Healthy volunteers willing to give informed consent for participation in the study&#xD;
&#xD;
          -  Patients diagnosed with a previous myocardial infarction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwillingness to participate&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  Contraindication to MRI scanning such as implantable cardiac devices&#xD;
&#xD;
          -  Participants who have had a previous myocardial infarction in the past of which they&#xD;
             may not be aware and this is discovered whilst being scanned on the 3T MRI scanner, or&#xD;
             who may have any other cardiology condition that they were previously unaware will not&#xD;
             be included in the healthy control group, even if they present themselves to us as&#xD;
             &quot;healthy&quot; at the time of the study visit&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Body habitus that may preclude comfortable positioning of the volunteer in either of&#xD;
             the MRI scanners (&gt;50cm in diameter)&#xD;
&#xD;
          -  Participants with abnormal kidney function that will preclude them from receiving a&#xD;
             contrast agent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dana Dawson, DPhil</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Aberdeen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>James Ross, PhD</last_name>
    <phone>01224437832</phone>
    <email>james.ross@abdn.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amelia Rudd, MSc</last_name>
    <phone>01224559473</phone>
    <phone_ext>01224559473</phone_ext>
    <email>a.e.rudd@abdn.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cardiovascular Research Facility</name>
      <address>
        <city>Aberdeen</city>
        <state>Aberdeenshire</state>
        <zip>AB25 2ZD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amelia Rudd, MSc</last_name>
      <phone>01224559473</phone>
      <phone_ext>01224559473</phone_ext>
      <email>a.e.rudd@abdn.ac.uk</email>
    </contact>
    <contact_backup>
      <last_name>James Ross, PhD</last_name>
      <phone>01224437832</phone>
      <email>james.ross@abdn.ac.uk</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>University of Aberdeen and NHS Grampian</name>
      <address>
        <city>Aberdeen</city>
        <state>Aberdeenshire</state>
        <zip>AB25 2ZD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stacey Dawson</last_name>
      <phone>07890095869</phone>
      <email>stacey.dawson@abdn.ac.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Broche LM, Ross PJ, Pine KJ, Lurie DJ. Rapid multi-field T(1) estimation algorithm for Fast Field-Cycling MRI. J Magn Reson. 2014 Jan;238:44-51. doi: 10.1016/j.jmr.2013.10.010. Epub 2013 Oct 31.</citation>
    <PMID>24309067</PMID>
  </reference>
  <reference>
    <citation>Kimmich R, Nusser W, Winter F. In vivo NMR field-cycling relaxation spectroscopy reveals 14N1H relaxation sinks in the backbones of proteins. Phys Med Biol. 1984 May;29(5):593-6. doi: 10.1088/0031-9155/29/5/011. No abstract available.</citation>
    <PMID>6739544</PMID>
  </reference>
  <reference>
    <citation>Broche LM, Ismail SR, Booth NA, Lurie DJ. Measurement of fibrin concentration by fast field-cycling NMR. Magn Reson Med. 2012 May;67(5):1453-7. doi: 10.1002/mrm.23117. Epub 2011 Oct 24.</citation>
    <PMID>22025420</PMID>
  </reference>
  <reference>
    <citation>Broche LM, Ashcroft GP, Lurie DJ. Detection of osteoarthritis in knee and hip joints by fast field-cycling NMR. Magn Reson Med. 2012 Aug;68(2):358-62. doi: 10.1002/mrm.23266. Epub 2011 Dec 12.</citation>
    <PMID>22161576</PMID>
  </reference>
  <reference>
    <citation>Scally C, Abbas H, Ahearn T, Srinivasan J, Mezincescu A, Rudd A, Spath N, Yucel-Finn A, Yuecel R, Oldroyd K, Dospinescu C, Horgan G, Broadhurst P, Henning A, Newby DE, Semple S, Wilson HM, Dawson DK. Myocardial and Systemic Inflammation in Acute Stress-Induced (Takotsubo) Cardiomyopathy. Circulation. 2019 Mar 26;139(13):1581-1592. doi: 10.1161/CIRCULATIONAHA.118.037975.</citation>
    <PMID>30586731</PMID>
  </reference>
  <reference>
    <citation>Antonopoulos AS, Sanna F, Sabharwal N, Thomas S, Oikonomou EK, Herdman L, Margaritis M, Shirodaria C, Kampoli AM, Akoumianakis I, Petrou M, Sayeed R, Krasopoulos G, Psarros C, Ciccone P, Brophy CM, Digby J, Kelion A, Uberoi R, Anthony S, Alexopoulos N, Tousoulis D, Achenbach S, Neubauer S, Channon KM, Antoniades C. Detecting human coronary inflammation by imaging perivascular fat. Sci Transl Med. 2017 Jul 12;9(398):eaal2658. doi: 10.1126/scitranslmed.aal2658.</citation>
    <PMID>28701474</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>May 12, 2023</last_update_submitted>
  <last_update_submitted_qc>May 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2023</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>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</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/NCT04458883
org study id: 2-010-20
nct id: NCT04458883
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main aim of the study is to build and test a cardiac-specific coil purposely assembled in
      house to suit the FFC-MRI whole-body prototype and to test if it could be used for clinical
      cardiac scans in human subject populations.
Aberdeen scientists are at the forefront of a new type of magnetic resonance imaging (MRI),
      having built in-house the only two available prototypes of Fast Field-Cycling MRI in the
      world - and these already have clinical imaging capabilities. Fast Field-Cycling MRI switches
      rapidly over a range of field strengths (0.2 T to 200 µT), providing a T1 dispersion curve.
      This information is invisible to fixed-field scanners and uncovers unique knowledge about
      motion and interaction between component molecules within a tissue (i.e. water/fat/proteins).
      In this application the investigators wish to use their in-house expertise further to extend
      the capability of our Fast Field-Cycling MRI to perform cardiac imaging by building the
      first-ever cardiac Fast Field-Cycling MRI coil and develop cardiac pulse sequences with ECG
      gating. The investigators will aim to establish the normalcy of T1 dispersion curves for left
      ventricular myocardium in healthy volunteers, and further on to distinguish the
      characteristics of post-myocardial infarction scar T1 dispersion curves.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: The main aim of the study is to build and test a cardiac-specific coil purposely assembled in house to suit the FFC-MRI whole-body prototype and to test if it could be used for clinical cardiac scans in human subject populations.
primary purpose: Basic Science
masking: None (Open Label)
measure: Cardiac Magnetic Resonance Imaging
time frame: At baseline
description: Cardiac Magnetic Resonance Imaging - Cardiac Scan to assess cardiac function and T1 dispersion curves
measure: Fast Field Cycling Magnetic Resonance Imaging
time frame: At baseline
description: Fast Field Cycling Magnetic Resonance Imaging - Cardiac Scan to assess cardiac function and T1 dispersion curves
arm group label: Myocardial Infarction Group
arm group type: Experimental
description: Patients diagnosed with a myocardial infarction
arm group label: Healthy Volunteers
arm group type: Experimental
description: Healthy Volunteers
intervention type: Procedure
intervention name: Cardiac Magnetic Resonance Imaging
description: Cardiac Magnetic Resonance Imaging - Cardiac Scan
arm group label: Healthy Volunteers
arm group label: Myocardial Infarction Group
intervention type: Procedure
intervention name: Fast Field Cycling - Magnetic Resonance Imaging
description: Fast Field Cycling - Magnetic Resonance Imaging Cardiac Scan
arm group label: Healthy Volunteers
arm group label: Myocardial Infarction Group
intervention type: Procedure
intervention name: Electrocardiogram
description: Electrocardiogram
arm group label: Healthy Volunteers
other name: ECG
intervention type: Procedure
intervention name: Echocardiogram
description: Echocardiogram
arm group label: Healthy Volunteers
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dana Dawson, DPhil
role: Principal Investigator
affiliation: University of Aberdeen
last name: James Ross, PhD
phone: 01224437832
email: james.ross@abdn.ac.uk
last name: Amelia Rudd, MSc
phone: 01224559473
phone ext: 01224559473
email: a.e.rudd@abdn.ac.uk
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
country: United Kingdom
citation: Broche LM, Ross PJ, Pine KJ, Lurie DJ. Rapid multi-field T(1) estimation algorithm for Fast Field-Cycling MRI. J Magn Reson. 2014 Jan;238:44-51. doi: 10.1016/j.jmr.2013.10.010. Epub 2013 Oct 31.
PMID: 24309067
citation: Kimmich R, Nusser W, Winter F. In vivo NMR field-cycling relaxation spectroscopy reveals 14N1H relaxation sinks in the backbones of proteins. Phys Med Biol. 1984 May;29(5):593-6. doi: 10.1088/0031-9155/29/5/011. No abstract available.
PMID: 6739544
citation: Broche LM, Ismail SR, Booth NA, Lurie DJ. Measurement of fibrin concentration by fast field-cycling NMR. Magn Reson Med. 2012 May;67(5):1453-7. doi: 10.1002/mrm.23117. Epub 2011 Oct 24.
PMID: 22025420
citation: Broche LM, Ashcroft GP, Lurie DJ. Detection of osteoarthritis in knee and hip joints by fast field-cycling NMR. Magn Reson Med. 2012 Aug;68(2):358-62. doi: 10.1002/mrm.23266. Epub 2011 Dec 12.
PMID: 22161576
citation: Scally C, Abbas H, Ahearn T, Srinivasan J, Mezincescu A, Rudd A, Spath N, Yucel-Finn A, Yuecel R, Oldroyd K, Dospinescu C, Horgan G, Broadhurst P, Henning A, Newby DE, Semple S, Wilson HM, Dawson DK. Myocardial and Systemic Inflammation in Acute Stress-Induced (Takotsubo) Cardiomyopathy. Circulation. 2019 Mar 26;139(13):1581-1592. doi: 10.1161/CIRCULATIONAHA.118.037975.
PMID: 30586731
citation: Antonopoulos AS, Sanna F, Sabharwal N, Thomas S, Oikonomou EK, Herdman L, Margaritis M, Shirodaria C, Kampoli AM, Akoumianakis I, Petrou M, Sayeed R, Krasopoulos G, Psarros C, Ciccone P, Brophy CM, Digby J, Kelion A, Uberoi R, Anthony S, Alexopoulos N, Tousoulis D, Achenbach S, Neubauer S, Channon KM, Antoniades C. Detecting human coronary inflammation by imaging perivascular fat. Sci Transl Med. 2017 Jul 12;9(398):eaal2658. doi: 10.1126/scitranslmed.aal2658.
PMID: 28701474
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Infarction
sharing ipd: No