<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/NCT04459169</url>
  </required_header>
  <id_info>
    <org_study_id>18_RIPH2-22</org_study_id>
    <nct_id>NCT04459169</nct_id>
  </id_info>
  <brief_title>Cardiac Amyloidosis : Diagnostic Using Red Flag Signals</brief_title>
  <acronym>TEAM Red Flags</acronym>
  <official_title>Early Echographic Screening of Cardiac Amyloidosis Using Red Flag Signals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Center of Martinique</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Center of Martinique</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>
      Cardiac amyloidosis is an increasingly contributor of degenerative cardiac diseases. However,&#xD;
      its frequency remains underestimated, and diagnosis is often realized at late stages of the&#xD;
      disease. A larger use of clinical and echographic Red Flag signals during routine&#xD;
      echocardiographic examination may enhance the identification of early stage of the disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective is to evaluate the clinical and epidemiological aspects of cardiac amyloidosis&#xD;
      using a systematic screening of even moderate left ventricular hypertrophy, taking into&#xD;
      account the presence of Red Flag signals. Red Flag Signals will include history or symptoms&#xD;
      of carpal tunnel syndrome, hearing loss, chronic gastrointestinal disorders, heart failure,&#xD;
      cervical or lumbar stenosis, or echographic abnormalities such as apical sparring, increased&#xD;
      left ventricular filling pressure, atrio-ventricular block.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 30, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of cardiac amyloidosis diagnosed according to Gillmore's algorithm</measure>
    <time_frame>3 months</time_frame>
    <description>frequency of cardiac amyloidosis diagnosed according to Gillmore's algorithm at the end of the diagnosis procedures, using biological (presence of cell dyscrasia), imaging (myocardial staining of bone tracers), and tissue examination (Congo Red staining) variables</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency genotype of Transthyretin cardiac amyloidosis according to Gillmore's algorithm</measure>
    <time_frame>5 months</time_frame>
    <description>Evaluate the frequency of Transthyretin cardiac amyloidosis among subjects with even moderate left ventricular enlargement (wall thickness ≥ 12 mm), taking into account the presence or not of Red Flag signals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of Red Flag signals according to Transthyretin genotype</measure>
    <time_frame>5 months</time_frame>
    <description>To Compare the distribution of Red Flag signals between wild type TTR cardiac amyloidosis and hereditary TTR cardiac amyloidosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnosis value of any Red Flag signal.</measure>
    <time_frame>5 months</time_frame>
    <description>To evaluate the diagnostic performance of each of the Red Flag signals for the diagnosis of TTR cardiac amyloidosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elaboration of a pre-test probability score</measure>
    <time_frame>5 months</time_frame>
    <description>To elaborate a pre-test probability score including the Red Flag signals, adapted to the Echo Lab settings.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">424</enrollment>
  <condition>Cardiac Amyloidosis</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>diagnostic algorithm</intervention_name>
    <description>Cardiac amyloidosis diagnosed according to Gillmore's algorithm</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Caribbeans who the large share of populations from African origin may be associated with a&#xD;
        high prevalence of Transthyretin amyloidosis.&#xD;
&#xD;
        In this population, diagnosis procedure will be perform to any patient with Left&#xD;
        Ventricular Hypertrophy (LVH) with wall thickness ≥ 12 mm associated with clinical&#xD;
        manifestations (or Red Flag signals&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of left ventricular hypertrophy defined by a parietal thickness&#xD;
             (interventricular septum or posterior wall) ≥ 12 mm on the echocardiogram&#xD;
&#xD;
          2. Age equal or greater than 45 years&#xD;
&#xD;
          3. Current residency in Martinique, Guadeloupe or French Guyana&#xD;
&#xD;
          4. Ability to receive and understand research information&#xD;
&#xD;
          5. Ability to freely deliver informed written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or breastfeeding woman&#xD;
&#xD;
          2. Severe uncontrolled hypertension&#xD;
&#xD;
          3. Chronic hemodialysis&#xD;
&#xD;
          4. Person under legal protection measures (guardianship, curatorship, safeguard of&#xD;
             justice), and person deprived of liberty&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Doctor INAMO Jocelyn</last_name>
    <role>Study Director</role>
    <affiliation>CHU de Martinique</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jocelyne CRASPAG, MSc</last_name>
    <phone>+596596592698</phone>
    <email>jocelyne.craspag@chu-martinique.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Doctor INAMO Jocelyn</last_name>
    <phone>+596596306410</phone>
    <email>jocelyn.inamo@chu-martinique.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre Hospitalier de Basse-Terre</name>
      <address>
        <city>Basse-Terre</city>
        <zip>97100</zip>
        <country>Guadeloupe</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>ATALLAH André, MD</last_name>
      <phone>+590590805449</phone>
      <email>atallah.andre@wanadoo.fr</email>
    </contact>
    <investigator>
      <last_name>ATALLAH André, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Martinique</name>
      <address>
        <city>Fort-de-France</city>
        <zip>97261</zip>
        <country>Martinique</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jocelyn INAMO, MD-PhD</last_name>
      <phone>+596596306422</phone>
      <email>jocelyn.inamo@chu-martinique.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Martinique</name>
      <address>
        <city>La Trinité</city>
        <zip>97220</zip>
        <country>Martinique</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Nathalie OZIER-LAFONTAINE, MD</last_name>
      <phone>+596596604846</phone>
      <email>nathalie.ozier-lafontaine@chu-martinique.fr</email>
    </contact>
    <investigator>
      <last_name>Nathalie OZIER-LAFONTAINE, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Guadeloupe</country>
    <country>Martinique</country>
  </location_countries>
  <link>
    <url>https://www.em-consulte.com/article/1192918/article/frequency-of-cardiac-amyloidosis-inpatients-with-u</url>
    <description>Frequency of cardiac amyloidosis inpatients with unexplained left ventricular hypertrophy: The Caribbean Amyloidosis Study</description>
  </link>
  <reference>
    <citation>Benson MD, Waddington-Cruz M, Berk JL, Polydefkis M, Dyck PJ, Wang AK, Plante-Bordeneuve V, Barroso FA, Merlini G, Obici L, Scheinberg M, Brannagan TH 3rd, Litchy WJ, Whelan C, Drachman BM, Adams D, Heitner SB, Conceicao I, Schmidt HH, Vita G, Campistol JM, Gamez J, Gorevic PD, Gane E, Shah AM, Solomon SD, Monia BP, Hughes SG, Kwoh TJ, McEvoy BW, Jung SW, Baker BF, Ackermann EJ, Gertz MA, Coelho T. Inotersen Treatment for Patients with Hereditary Transthyretin Amyloidosis. N Engl J Med. 2018 Jul 5;379(1):22-31. doi: 10.1056/NEJMoa1716793.</citation>
    <PMID>29972757</PMID>
  </reference>
  <reference>
    <citation>Coelho T, Adams D, Silva A, Lozeron P, Hawkins PN, Mant T, Perez J, Chiesa J, Warrington S, Tranter E, Munisamy M, Falzone R, Harrop J, Cehelsky J, Bettencourt BR, Geissler M, Butler JS, Sehgal A, Meyers RE, Chen Q, Borland T, Hutabarat RM, Clausen VA, Alvarez R, Fitzgerald K, Gamba-Vitalo C, Nochur SV, Vaishnaw AK, Sah DW, Gollob JA, Suhr OB. Safety and efficacy of RNAi therapy for transthyretin amyloidosis. N Engl J Med. 2013 Aug 29;369(9):819-29. doi: 10.1056/NEJMoa1208760.</citation>
    <PMID>23984729</PMID>
  </reference>
  <reference>
    <citation>Di Nunzio D, Recupero A, de Gregorio C, Zito C, Carerj S, Di Bella G. Echocardiographic Findings in Cardiac Amyloidosis: Inside Two-Dimensional, Doppler, and Strain Imaging. Curr Cardiol Rep. 2019 Feb 12;21(2):7. doi: 10.1007/s11886-019-1094-z.</citation>
    <PMID>30747298</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>November 16, 2020</last_update_submitted>
  <last_update_submitted_qc>November 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2020</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>Amyloidosis</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/NCT04459169
org study id: 18_RIPH2-22
nct id: NCT04459169
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cardiac amyloidosis is an increasingly contributor of degenerative cardiac diseases. However,
      its frequency remains underestimated, and diagnosis is often realized at late stages of the
      disease. A larger use of clinical and echographic Red Flag signals during routine
      echocardiographic examination may enhance the identification of early stage of the disease.
The objective is to evaluate the clinical and epidemiological aspects of cardiac amyloidosis
      using a systematic screening of even moderate left ventricular hypertrophy, taking into
      account the presence of Red Flag signals. Red Flag Signals will include history or symptoms
      of carpal tunnel syndrome, hearing loss, chronic gastrointestinal disorders, heart failure,
      cervical or lumbar stenosis, or echographic abnormalities such as apical sparring, increased
      left ventricular filling pressure, atrio-ventricular block.
observational model: Case-Only
time perspective: Prospective
measure: Frequency of cardiac amyloidosis diagnosed according to Gillmore's algorithm
time frame: 3 months
description: frequency of cardiac amyloidosis diagnosed according to Gillmore's algorithm at the end of the diagnosis procedures, using biological (presence of cell dyscrasia), imaging (myocardial staining of bone tracers), and tissue examination (Congo Red staining) variables
measure: Frequency genotype of Transthyretin cardiac amyloidosis according to Gillmore's algorithm
time frame: 5 months
description: Evaluate the frequency of Transthyretin cardiac amyloidosis among subjects with even moderate left ventricular enlargement (wall thickness ≥ 12 mm), taking into account the presence or not of Red Flag signals
measure: Distribution of Red Flag signals according to Transthyretin genotype
time frame: 5 months
description: To Compare the distribution of Red Flag signals between wild type TTR cardiac amyloidosis and hereditary TTR cardiac amyloidosis
measure: Diagnosis value of any Red Flag signal.
time frame: 5 months
description: To evaluate the diagnostic performance of each of the Red Flag signals for the diagnosis of TTR cardiac amyloidosis
measure: Elaboration of a pre-test probability score
time frame: 5 months
description: To elaborate a pre-test probability score including the Red Flag signals, adapted to the Echo Lab settings.
intervention type: Procedure
intervention name: diagnostic algorithm
description: Cardiac amyloidosis diagnosed according to Gillmore's algorithm
whole blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Doctor INAMO Jocelyn
role: Study Director
affiliation: CHU de Martinique
last name: Jocelyne CRASPAG, MSc
phone: +596596592698
email: jocelyne.craspag@chu-martinique.fr
last name: Doctor INAMO Jocelyn
phone: +596596306410
email: jocelyn.inamo@chu-martinique.fr
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: Guadeloupe
country: Martinique
url: https://www.em-consulte.com/article/1192918/article/frequency-of-cardiac-amyloidosis-inpatients-with-u
description: Frequency of cardiac amyloidosis inpatients with unexplained left ventricular hypertrophy: The Caribbean Amyloidosis Study
citation: Benson MD, Waddington-Cruz M, Berk JL, Polydefkis M, Dyck PJ, Wang AK, Plante-Bordeneuve V, Barroso FA, Merlini G, Obici L, Scheinberg M, Brannagan TH 3rd, Litchy WJ, Whelan C, Drachman BM, Adams D, Heitner SB, Conceicao I, Schmidt HH, Vita G, Campistol JM, Gamez J, Gorevic PD, Gane E, Shah AM, Solomon SD, Monia BP, Hughes SG, Kwoh TJ, McEvoy BW, Jung SW, Baker BF, Ackermann EJ, Gertz MA, Coelho T. Inotersen Treatment for Patients with Hereditary Transthyretin Amyloidosis. N Engl J Med. 2018 Jul 5;379(1):22-31. doi: 10.1056/NEJMoa1716793.
PMID: 29972757
citation: Coelho T, Adams D, Silva A, Lozeron P, Hawkins PN, Mant T, Perez J, Chiesa J, Warrington S, Tranter E, Munisamy M, Falzone R, Harrop J, Cehelsky J, Bettencourt BR, Geissler M, Butler JS, Sehgal A, Meyers RE, Chen Q, Borland T, Hutabarat RM, Clausen VA, Alvarez R, Fitzgerald K, Gamba-Vitalo C, Nochur SV, Vaishnaw AK, Sah DW, Gollob JA, Suhr OB. Safety and efficacy of RNAi therapy for transthyretin amyloidosis. N Engl J Med. 2013 Aug 29;369(9):819-29. doi: 10.1056/NEJMoa1208760.
PMID: 23984729
citation: Di Nunzio D, Recupero A, de Gregorio C, Zito C, Carerj S, Di Bella G. Echocardiographic Findings in Cardiac Amyloidosis: Inside Two-Dimensional, Doppler, and Strain Imaging. Curr Cardiol Rep. 2019 Feb 12;21(2):7. doi: 10.1007/s11886-019-1094-z.
PMID: 30747298
responsible party type: Sponsor
mesh term: Amyloidosis