<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/NCT02973633</url>
  </required_header>
  <id_info>
    <org_study_id>2016P001898</org_study_id>
    <nct_id>NCT02973633</nct_id>
  </id_info>
  <brief_title>Diffusion MRI in Heart Failure</brief_title>
  <official_title>Diffusion MRI in Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The development of symptomatic heart failure is frequently preceded by a pre-clinical period&#xD;
      of structural remodeling in the heart. The remodeling process driving this transition,&#xD;
      however, remains poorly understood. The investigators hypothesize that imaging the diffusion&#xD;
      of water in the heart with MRI will allow its microstructure to be resolved. The&#xD;
      investigators further hypothesize that the characterization of microstructural changes in the&#xD;
      heart will help elucidate the pathogenesis of heart failure and the transition from a&#xD;
      compensated to a decompensated state. Patients with recent myocardial infarcts and left&#xD;
      ventricular hypertrophy, who are at risk for the development of heart failure, will be&#xD;
      enrolled. The participants will undergo serial diffusion tensor MRI (DTI) imaging of the&#xD;
      heart to characterize changes in myocardial microstructure over time.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 30, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>Early Phase 1</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Myofiber Helix Angle</measure>
    <time_frame>12 months</time_frame>
    <description>The investigators aim to determine how the myofibers in the heart change their orientation in heart disease by measuring their helix angle.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of Myofiber Helix Angle and Strain</measure>
    <time_frame>12 months</time_frame>
    <description>The investigators aim to correlate how changes in fiber architecture correlate with changes in left ventricular strain.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Heart Failure</condition>
  <condition>Myocardial Infarction</condition>
  <condition>Left Ventricular Hypertrophy</condition>
  <arm_group>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>DTI will be performed in healthy volunteers to characterize normal fiber architecture in the heart and provide a comparison group for the patients imaged in the other arms.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with Recent Myocardial Infarction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with recent ST elevation myocardial infarcts will be recruited and imaged serially with DTI to detect changes in fiber architecture and their correlation with remodeling of the left ventricle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with Left Ventricular Hypertrophy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with left ventricular hypertrophy and a history of heart failure will be recruited and imaged serially with DTI to detect changes in fiber architecture and their correlation with the onset and progression of heart failure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Diffusion Tensor MRI (DTI)</intervention_name>
    <description>Diffusion Tensor MRI (DTI) measures the diffusion of water in the heart, which allows the orientation of the muscle fibers in the heart to be determined.</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Patients with Left Ventricular Hypertrophy</arm_group_label>
    <arm_group_label>Patients with Recent Myocardial Infarction</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gadolinium DOTA Meglumine</intervention_name>
    <description>Late Gadolinium enhancement</description>
    <arm_group_label>Patients with Recent Myocardial Infarction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adults with no history of hypertension, diabetes or heart disease&#xD;
&#xD;
          -  Patients with ST Elevation MI within last 6-10 weeks who are angina free, and have&#xD;
             been seen by a cardiologist since discharge&#xD;
&#xD;
          -  Patients with episode of heart failure within last 12 months and left ventricular&#xD;
             hypertrophy, documented by echocardiogram or MRI.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of metallic foreign bodies/objects&#xD;
&#xD;
          2. Selected medical devices and implants&#xD;
&#xD;
          3. Pacemakers, implantable defibrillators, life vests&#xD;
&#xD;
          4. Coronary artery stent within last 6 weeks (unless the stent is a MRI-inert&#xD;
             chromium-cobalt stent)&#xD;
&#xD;
          5. Known untreated ventricular arrhythmia such as sustained ventricular tachycardia&#xD;
             within last 12 months&#xD;
&#xD;
          6. Atrial fibrillation that is not well rate controlled (heart rate &gt;125)&#xD;
&#xD;
          7. Unstable angina within last 2 months that has not been fully evaluated by a&#xD;
             cardiologist&#xD;
&#xD;
          8. Syncope within last 6 weeks&#xD;
&#xD;
          9. Hemodynamic instability (Systolic BP less than 100 or greater than 180)&#xD;
&#xD;
         10. Decompensated heart failure (inability to lie flat and perform a breath-hold).&#xD;
&#xD;
         11. Glomerular filtration rate (GFR) &lt; 60 for those receiving gadolinium.&#xD;
&#xD;
         12. Labile GFR that is not stable/similar on last 2 measurements (for those receiving&#xD;
             gadolinium).&#xD;
&#xD;
         13. Patients with GFR &lt; 20 or on any form of dialysis.&#xD;
&#xD;
         14. Infiltrative cardiomyopathy (amyloid, sarcoid, hemachromatosis)&#xD;
&#xD;
         15. Recent surgery (within the last 3 months)&#xD;
&#xD;
         16. Prior stroke with large residual deficit&#xD;
&#xD;
         17. Presence of liver or respiratory failure&#xD;
&#xD;
         18. Pregnancy and nursing mothers&#xD;
&#xD;
         19. Claustrophobia&#xD;
&#xD;
         20. Known seizure disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David E. Sosnovik, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>David E. Sosnovik, MD</last_name>
    <phone>617-724-3407</phone>
    <email>sosnovik@nmr.mgh.harvard.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Charlestown</city>
        <state>Massachusetts</state>
        <zip>02129</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Mekkaoui C, Reese TG, Jackowski MP, Cauley SF, Setsompop K, Bhat H, Sosnovik DE. Diffusion Tractography of the Entire Left Ventricle by Using Free-breathing Accelerated Simultaneous Multisection Imaging. Radiology. 2017 Mar;282(3):850-856. doi: 10.1148/radiol.2016152613. Epub 2016 Sep 28.</citation>
    <PMID>27681278</PMID>
  </results_reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 19, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>March 1, 2022</last_update_submitted>
  <last_update_submitted_qc>March 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>David E Sosnovik</investigator_full_name>
    <investigator_title>Associate Professor of Medicine, Harvard Medical School</investigator_title>
  </responsible_party>
  <keyword>Heart Failure</keyword>
  <keyword>Remodeling</keyword>
  <keyword>Myocardial Infarction</keyword>
  <keyword>Left Ventricular Hypertrophy</keyword>
  <keyword>Diffusion Tensor MRI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Hypertrophy, Left Ventricular</mesh_term>
    <mesh_term>Infarction</mesh_term>
    <mesh_term>Hypertrophy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD will not be shared</ipd_description>
  </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/NCT02973633
org study id: 2016P001898
nct id: NCT02973633
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: Yes
The development of symptomatic heart failure is frequently preceded by a pre-clinical period
      of structural remodeling in the heart. The remodeling process driving this transition,
      however, remains poorly understood. The investigators hypothesize that imaging the diffusion
      of water in the heart with MRI will allow its microstructure to be resolved. The
      investigators further hypothesize that the characterization of microstructural changes in the
      heart will help elucidate the pathogenesis of heart failure and the transition from a
      compensated to a decompensated state. Patients with recent myocardial infarcts and left
      ventricular hypertrophy, who are at risk for the development of heart failure, will be
      enrolled. The participants will undergo serial diffusion tensor MRI (DTI) imaging of the
      heart to characterize changes in myocardial microstructure over time.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: Myofiber Helix Angle
time frame: 12 months
description: The investigators aim to determine how the myofibers in the heart change their orientation in heart disease by measuring their helix angle.
measure: Correlation of Myofiber Helix Angle and Strain
time frame: 12 months
description: The investigators aim to correlate how changes in fiber architecture correlate with changes in left ventricular strain.
arm group label: Healthy Volunteers
arm group type: Active Comparator
description: DTI will be performed in healthy volunteers to characterize normal fiber architecture in the heart and provide a comparison group for the patients imaged in the other arms.
arm group label: Patients with Recent Myocardial Infarction
arm group type: Active Comparator
description: Patients with recent ST elevation myocardial infarcts will be recruited and imaged serially with DTI to detect changes in fiber architecture and their correlation with remodeling of the left ventricle.
arm group label: Patients with Left Ventricular Hypertrophy
arm group type: Active Comparator
description: Patients with left ventricular hypertrophy and a history of heart failure will be recruited and imaged serially with DTI to detect changes in fiber architecture and their correlation with the onset and progression of heart failure.
intervention type: Device
intervention name: Diffusion Tensor MRI (DTI)
description: Diffusion Tensor MRI (DTI) measures the diffusion of water in the heart, which allows the orientation of the muscle fibers in the heart to be determined.
arm group label: Healthy Volunteers
arm group label: Patients with Left Ventricular Hypertrophy
arm group label: Patients with Recent Myocardial Infarction
intervention type: Drug
intervention name: Gadolinium DOTA Meglumine
description: Late Gadolinium enhancement
arm group label: Patients with Recent Myocardial Infarction
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David E. Sosnovik, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: David E. Sosnovik, MD
phone: 617-724-3407
email: sosnovik@nmr.mgh.harvard.edu
facility: 
status: Recruiting
country: United States
citation: Mekkaoui C, Reese TG, Jackowski MP, Cauley SF, Setsompop K, Bhat H, Sosnovik DE. Diffusion Tractography of the Entire Left Ventricle by Using Free-breathing Accelerated Simultaneous Multisection Imaging. Radiology. 2017 Mar;282(3):850-856. doi: 10.1148/radiol.2016152613. Epub 2016 Sep 28.
PMID: 27681278
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: David E Sosnovik
investigator title: Associate Professor of Medicine, Harvard Medical School
mesh term: Heart Failure
mesh term: Myocardial Infarction
mesh term: Hypertrophy, Left Ventricular
mesh term: Infarction
mesh term: Hypertrophy
mesh term: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
sharing ipd: No
ipd description: IPD will not be shared