<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/NCT03278457</url>
  </required_header>
  <id_info>
    <org_study_id>2017021</org_study_id>
    <nct_id>NCT03278457</nct_id>
  </id_info>
  <brief_title>Risk Stratification Using PET in HCM</brief_title>
  <acronym>HCM-PET</acronym>
  <official_title>Risk Stratification Using Positron Emission Tomography (PET) in Hypertrophic Cardiomyopathy (HCM)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Gävleborg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Landstinget i Värmland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dalarna County Council, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Uppsala University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Region Gävleborg</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 overall rationale is to reduce the risk of sudden cardiac death in individuals with&#xD;
      hypertrophic cardiomyopathy (HCM). The novel approach of this study is to correlate Positron&#xD;
      Emission Tomography (PET) findings to ventricular arrhythmias detected by the implantable&#xD;
      cardioverter defibrillator (ICD). This could potentially lead to an improved risk&#xD;
      stratification of HCM patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Positron Emission Tomography (PET) is a functional imaging technique that utilizes&#xD;
      radioactive tracers to gain information on physiological or pathophysiological processes in&#xD;
      vivo. Different tracers can provide information on different processes of interest. In&#xD;
      cardiology, metabolic processes consuming oxygen (aerobic) can be studied with&#xD;
      11-Carbon-Acetate, sympathetic innervation can be studied with 11-Carbon-hydroxyephedrine and&#xD;
      using 15-Oxygen-water the myocardial blood flow. Structural information of the heart such as&#xD;
      left ventricular mass, left ventricular volumes and wall thickness can also be calculated&#xD;
      with PET.&#xD;
&#xD;
      The aim is to correlate PET parameters and burden of ventricular arrhythmias in order to&#xD;
      improve risk stratification in HCM.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 3, 2017</start_date>
  <completion_date type="Anticipated">June 3, 2018</completion_date>
  <primary_completion_date type="Anticipated">January 3, 2018</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>Ventricular tachycardia (VT) vs myocardial blood flow</measure>
    <time_frame>History of VT since receiving an implantable defibrillator within last 15 years</time_frame>
    <description>Ventricular tachycardia vs positron emissions tomography parameter Myocardial blood flow (MBF)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ventricular tachycardia (VT) vs ejection fraction</measure>
    <time_frame>History of VT since receiving an implantable defibrillator within last 15 years</time_frame>
    <description>Ventricular tachycardia vs positron emissions tomography parameter ejection fraction (EF)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ventricular tachycardia (VT) vs mass</measure>
    <time_frame>History of VT since receiving an implantable defibrillator within last 15 years</time_frame>
    <description>Ventricular tachycardia vs positron emissions tomography parameter mass</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ventricular tachycardia (VT) vs wall thickness</measure>
    <time_frame>History of VT since receiving an implantable defibrillator within last 15 years</time_frame>
    <description>Ventricular tachycardia vs positron emissions tomography parameter wall thickness</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ventricular tachycardia (VT) vs oxygen consumption</measure>
    <time_frame>History of VT since receiving an implantable defibrillator within last 15 years</time_frame>
    <description>Ventricular tachycardia vs positron emissions tomography parameter oxygen consumption (MVO2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ventricular tachycardia (VT) vs sympathetic innervation</measure>
    <time_frame>History of VT since receiving an implantable defibrillator within last 15 years</time_frame>
    <description>Ventricular tachycardia vs positron emissions tomography parameter sympathetic innervation (retention index)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ventricular tachycardia (VT) vs myocardial external efficiency</measure>
    <time_frame>History of VT since receiving an implantable defibrillator within last 15 years</time_frame>
    <description>Ventricular tachycardia vs positron emissions tomography parameter myocardial external efficiency (MEE)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ventricular tachycardia (VT) vs stroke work</measure>
    <time_frame>History of VT since receiving an implantable defibrillator within last 15 years</time_frame>
    <description>Ventricular tachycardia vs positron emissions tomography parameter stroke work (SW)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Atrial fibrillation (AF) vs myocardial blood flow</measure>
    <time_frame>History of VT since receiving an implantable defibrillator within last 15 years</time_frame>
    <description>Atrial fibrillation vs positron emissions tomography parameter myocardial blood flow</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial fibrillation (AF) vs ejection fraction</measure>
    <time_frame>History of VT since receiving an implantable defibrillator within last 15 years</time_frame>
    <description>Atrial fibrillation vs positron emissions tomography parameter ejection fraction (EF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial fibrillation (AF) vs mass</measure>
    <time_frame>History of VT since receiving an implantable defibrillator within last 15 years</time_frame>
    <description>Atrial fibrillation vs positron emissions tomography parameter mass</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial fibrillation (AF) vs wall thickness</measure>
    <time_frame>History of VT since receiving an implantable defibrillator within last 15 years</time_frame>
    <description>Atrial fibrillation vs positron emissions tomography parameter wall thickness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial fibrillation (AF) vs oxygen consumption</measure>
    <time_frame>History of VT since receiving an implantable defibrillator within last 15 years</time_frame>
    <description>Atrial fibrillation vs positron emissions tomography parameter oxygen consumption (MVO2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial fibrillation (AF) vs sympathetic innervation</measure>
    <time_frame>History of VT since receiving an implantable defibrillator within last 15 years</time_frame>
    <description>Atrial fibrillation vs positron emissions tomography parameter sympathetic innervation (retention index)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial fibrillation (AF) vs myocardial external efficiency</measure>
    <time_frame>History of VT since receiving an implantable defibrillator within last 15 years</time_frame>
    <description>Atrial fibrillation vs positron emissions tomography parameter myocardial external efficiency (MEE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial fibrillation (AF) vs stroke work</measure>
    <time_frame>History of VT since receiving an implantable defibrillator within last 15 years</time_frame>
    <description>Atrial fibrillation vs positron emissions tomography parameter stroke work (SW)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial size vs ventricular tachycardia</measure>
    <time_frame>History of VT since receiving an implantable defibrillator within last 15 years</time_frame>
    <description>atrial diameter, volume vs ventricular tachycardia</description>
  </secondary_outcome>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Hypertrophic Cardiomyopathy</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Positron Emission Tomography</intervention_name>
    <description>Positron Emission Tomography</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with hypertrophic cardiomyopathy (HCM) and an implantable defibrillator (ICD)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hypertrophic cardiomyopathy, implantable cardioverter defibrillator, informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 18 years, pregnancy, breast feeding, claustrophobia,&#xD;
             intolerance/allergic reaction to adenosin or mannitol, severe hypotension, unstable&#xD;
             angina pectoris, incompensated systolic heart failure, increased intracranial&#xD;
             pressure, hypovolemia, dipyramidole.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Jens Sörensen, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Region Gävleborg</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Peter Magnusson, MD</last_name>
    <phone>+46705089407</phone>
    <email>peter.magnusson@regiongavleborg.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jonny Nordström, MSc</last_name>
    <phone>+46725727670</phone>
    <email>jonny.nordstrom@regiongavleborg.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Region Gavleborg</name>
      <address>
        <city>Gävle</city>
        <zip>80324</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Magnusson, M.D.</last_name>
      <phone>+46705089407</phone>
      <email>peter.magnusson@regiongavleborg.se</email>
    </contact>
    <contact_backup>
      <last_name>Jonny Nordström, MSc</last_name>
      <phone>+46725727670</phone>
      <email>jonny.nordstrom@regiongavleborg.se</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Authors/Task Force members; Elliott PM, Anastasakis A, Borger MA, Borggrefe M, Cecchi F, Charron P, Hagege AA, Lafont A, Limongelli G, Mahrholdt H, McKenna WJ, Mogensen J, Nihoyannopoulos P, Nistri S, Pieper PG, Pieske B, Rapezzi C, Rutten FH, Tillmanns C, Watkins H. 2014 ESC Guidelines on diagnosis and management of hypertrophic cardiomyopathy: the Task Force for the Diagnosis and Management of Hypertrophic Cardiomyopathy of the European Society of Cardiology (ESC). Eur Heart J. 2014 Oct 14;35(39):2733-79. doi: 10.1093/eurheartj/ehu284. Epub 2014 Aug 29. No abstract available.</citation>
    <PMID>25173338</PMID>
  </reference>
  <reference>
    <citation>Maron BJ, Olivotto I, Spirito P, Casey SA, Bellone P, Gohman TE, Graham KJ, Burton DA, Cecchi F. Epidemiology of hypertrophic cardiomyopathy-related death: revisited in a large non-referral-based patient population. Circulation. 2000 Aug 22;102(8):858-64. doi: 10.1161/01.cir.102.8.858.</citation>
    <PMID>10952953</PMID>
  </reference>
  <reference>
    <citation>Timmer SA, Germans T, Gotte MJ, Russel IK, Dijkmans PA, Lubberink M, ten Berg JM, ten Cate FJ, Lammertsma AA, Knaapen P, van Rossum AC. Determinants of myocardial energetics and efficiency in symptomatic hypertrophic cardiomyopathy. Eur J Nucl Med Mol Imaging. 2010 Apr;37(4):779-88. doi: 10.1007/s00259-009-1350-3. Epub 2010 Jan 13.</citation>
    <PMID>20069294</PMID>
  </reference>
  <reference>
    <citation>Kofflard MJ, Ten Cate FJ, van der Lee C, van Domburg RT. Hypertrophic cardiomyopathy in a large community-based population: clinical outcome and identification of risk factors for sudden cardiac death and clinical deterioration. J Am Coll Cardiol. 2003 Mar 19;41(6):987-93. doi: 10.1016/s0735-1097(02)03004-8.</citation>
    <PMID>12651046</PMID>
  </reference>
  <reference>
    <citation>Timmer SA, Germans T, Gotte MJ, Russel IK, Lubberink M, Ten Berg JM, Ten Cate FJ, Lammertsma AA, Knaapen P, van Rossum AC. Relation of coronary microvascular dysfunction in hypertrophic cardiomyopathy to contractile dysfunction independent from myocardial injury. Am J Cardiol. 2011 May 15;107(10):1522-8. doi: 10.1016/j.amjcard.2011.01.029. Epub 2011 Mar 4.</citation>
    <PMID>21377644</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>September 7, 2017</last_update_submitted>
  <last_update_submitted_qc>September 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hypertrophic cardiomyopathy</keyword>
  <keyword>implantable cardioverter defibrillator</keyword>
  <keyword>positron emission tomography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiomyopathies</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/NCT03278457
org study id: 2017021
nct id: NCT03278457
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall rationale is to reduce the risk of sudden cardiac death in individuals with
      hypertrophic cardiomyopathy (HCM). The novel approach of this study is to correlate Positron
      Emission Tomography (PET) findings to ventricular arrhythmias detected by the implantable
      cardioverter defibrillator (ICD). This could potentially lead to an improved risk
      stratification of HCM patients.
Positron Emission Tomography (PET) is a functional imaging technique that utilizes
      radioactive tracers to gain information on physiological or pathophysiological processes in
      vivo. Different tracers can provide information on different processes of interest. In
      cardiology, metabolic processes consuming oxygen (aerobic) can be studied with
      11-Carbon-Acetate, sympathetic innervation can be studied with 11-Carbon-hydroxyephedrine and
      using 15-Oxygen-water the myocardial blood flow. Structural information of the heart such as
      left ventricular mass, left ventricular volumes and wall thickness can also be calculated
      with PET.

      The aim is to correlate PET parameters and burden of ventricular arrhythmias in order to
      improve risk stratification in HCM.
observational model: Cohort
time perspective: Other
measure: Ventricular tachycardia (VT) vs myocardial blood flow
time frame: History of VT since receiving an implantable defibrillator within last 15 years
description: Ventricular tachycardia vs positron emissions tomography parameter Myocardial blood flow (MBF)
measure: Ventricular tachycardia (VT) vs ejection fraction
time frame: History of VT since receiving an implantable defibrillator within last 15 years
description: Ventricular tachycardia vs positron emissions tomography parameter ejection fraction (EF)
measure: Ventricular tachycardia (VT) vs mass
time frame: History of VT since receiving an implantable defibrillator within last 15 years
description: Ventricular tachycardia vs positron emissions tomography parameter mass
measure: Ventricular tachycardia (VT) vs wall thickness
time frame: History of VT since receiving an implantable defibrillator within last 15 years
description: Ventricular tachycardia vs positron emissions tomography parameter wall thickness
measure: Ventricular tachycardia (VT) vs oxygen consumption
time frame: History of VT since receiving an implantable defibrillator within last 15 years
description: Ventricular tachycardia vs positron emissions tomography parameter oxygen consumption (MVO2)
measure: Ventricular tachycardia (VT) vs sympathetic innervation
time frame: History of VT since receiving an implantable defibrillator within last 15 years
description: Ventricular tachycardia vs positron emissions tomography parameter sympathetic innervation (retention index)
measure: Ventricular tachycardia (VT) vs myocardial external efficiency
time frame: History of VT since receiving an implantable defibrillator within last 15 years
description: Ventricular tachycardia vs positron emissions tomography parameter myocardial external efficiency (MEE)
measure: Ventricular tachycardia (VT) vs stroke work
time frame: History of VT since receiving an implantable defibrillator within last 15 years
description: Ventricular tachycardia vs positron emissions tomography parameter stroke work (SW)
measure: Atrial fibrillation (AF) vs myocardial blood flow
time frame: History of VT since receiving an implantable defibrillator within last 15 years
description: Atrial fibrillation vs positron emissions tomography parameter myocardial blood flow
measure: Atrial fibrillation (AF) vs ejection fraction
time frame: History of VT since receiving an implantable defibrillator within last 15 years
description: Atrial fibrillation vs positron emissions tomography parameter ejection fraction (EF)
measure: Atrial fibrillation (AF) vs mass
time frame: History of VT since receiving an implantable defibrillator within last 15 years
description: Atrial fibrillation vs positron emissions tomography parameter mass
measure: Atrial fibrillation (AF) vs wall thickness
time frame: History of VT since receiving an implantable defibrillator within last 15 years
description: Atrial fibrillation vs positron emissions tomography parameter wall thickness
measure: Atrial fibrillation (AF) vs oxygen consumption
time frame: History of VT since receiving an implantable defibrillator within last 15 years
description: Atrial fibrillation vs positron emissions tomography parameter oxygen consumption (MVO2)
measure: Atrial fibrillation (AF) vs sympathetic innervation
time frame: History of VT since receiving an implantable defibrillator within last 15 years
description: Atrial fibrillation vs positron emissions tomography parameter sympathetic innervation (retention index)
measure: Atrial fibrillation (AF) vs myocardial external efficiency
time frame: History of VT since receiving an implantable defibrillator within last 15 years
description: Atrial fibrillation vs positron emissions tomography parameter myocardial external efficiency (MEE)
measure: Atrial fibrillation (AF) vs stroke work
time frame: History of VT since receiving an implantable defibrillator within last 15 years
description: Atrial fibrillation vs positron emissions tomography parameter stroke work (SW)
measure: Atrial size vs ventricular tachycardia
time frame: History of VT since receiving an implantable defibrillator within last 15 years
description: atrial diameter, volume vs ventricular tachycardia
intervention type: Diagnostic Test
intervention name: Positron Emission Tomography
description: Positron Emission Tomography
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Jens Sörensen, MD PhD
role: Principal Investigator
affiliation: Region Gävleborg
last name: Peter Magnusson, MD
phone: +46705089407
email: peter.magnusson@regiongavleborg.se
last name: Jonny Nordström, MSc
phone: +46725727670
email: jonny.nordstrom@regiongavleborg.se
facility: 
status: Recruiting
contact: 
contact backup: 
country: Sweden
citation: Authors/Task Force members; Elliott PM, Anastasakis A, Borger MA, Borggrefe M, Cecchi F, Charron P, Hagege AA, Lafont A, Limongelli G, Mahrholdt H, McKenna WJ, Mogensen J, Nihoyannopoulos P, Nistri S, Pieper PG, Pieske B, Rapezzi C, Rutten FH, Tillmanns C, Watkins H. 2014 ESC Guidelines on diagnosis and management of hypertrophic cardiomyopathy: the Task Force for the Diagnosis and Management of Hypertrophic Cardiomyopathy of the European Society of Cardiology (ESC). Eur Heart J. 2014 Oct 14;35(39):2733-79. doi: 10.1093/eurheartj/ehu284. Epub 2014 Aug 29. No abstract available.
PMID: 25173338
citation: Maron BJ, Olivotto I, Spirito P, Casey SA, Bellone P, Gohman TE, Graham KJ, Burton DA, Cecchi F. Epidemiology of hypertrophic cardiomyopathy-related death: revisited in a large non-referral-based patient population. Circulation. 2000 Aug 22;102(8):858-64. doi: 10.1161/01.cir.102.8.858.
PMID: 10952953
citation: Timmer SA, Germans T, Gotte MJ, Russel IK, Dijkmans PA, Lubberink M, ten Berg JM, ten Cate FJ, Lammertsma AA, Knaapen P, van Rossum AC. Determinants of myocardial energetics and efficiency in symptomatic hypertrophic cardiomyopathy. Eur J Nucl Med Mol Imaging. 2010 Apr;37(4):779-88. doi: 10.1007/s00259-009-1350-3. Epub 2010 Jan 13.
PMID: 20069294
citation: Kofflard MJ, Ten Cate FJ, van der Lee C, van Domburg RT. Hypertrophic cardiomyopathy in a large community-based population: clinical outcome and identification of risk factors for sudden cardiac death and clinical deterioration. J Am Coll Cardiol. 2003 Mar 19;41(6):987-93. doi: 10.1016/s0735-1097(02)03004-8.
PMID: 12651046
citation: Timmer SA, Germans T, Gotte MJ, Russel IK, Lubberink M, Ten Berg JM, Ten Cate FJ, Lammertsma AA, Knaapen P, van Rossum AC. Relation of coronary microvascular dysfunction in hypertrophic cardiomyopathy to contractile dysfunction independent from myocardial injury. Am J Cardiol. 2011 May 15;107(10):1522-8. doi: 10.1016/j.amjcard.2011.01.029. Epub 2011 Mar 4.
PMID: 21377644
responsible party type: Sponsor
mesh term: Cardiomyopathies
mesh term: Cardiomyopathy, Hypertrophic
mesh term: Hypertrophy
sharing ipd: No