xml: <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/NCT06013722</url>
    </required_header>
    <id_info>
      <org_study_id>2023-CHITS-007</org_study_id>
      <nct_id>NCT06013722</nct_id>
    </id_info>
    <brief_title>Strategy for Unstable Coronary Plaque in Patients Presenting to Emergency Department for Chest Pain Suspected of Coronary Artery Disease</brief_title>
    <acronym>SPECTRE</acronym>
    <official_title>Strategy for Unstable Coronary Plaque in Patients Presenting to the Emergency Department for Chest Pain Suspected of Coronary Artery Disease. A Trial in Primary Prevention and Cardiovascular Risks Evaluation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Monaco Scientific center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer</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>
        Primary prevention of coronary disease and especially its major complication, inaugural&#xD;
        myocardial infarction, is based on any prodromal symptoms identification and on risk profile&#xD;
        establishment. About 50% of myocardial infarctions are caused by an unstable non-stenosing&#xD;
        plaque, asymptomatic before the event since without significant reduction in coronary flow,&#xD;
        particularly during a stress test or during stress imaging.&#xD;
  &#xD;
        Study purpose is to set up, in medical emergency department, check-up unit and cardiology&#xD;
        department, a primary prevention strategy articulated around a routine examination: calcium&#xD;
        scoring. The latter makes it possible to categorize patients according to their risk of&#xD;
        generating atheromatous plaques and to classify them into several risk levels (groups)&#xD;
        according to their score: low (&lt;40th percentile), intermediate (between the 40th percentile&#xD;
        and the 65th percentile: group III) or high risk (&gt;65th percentile, group IV). 18F-Na PET&#xD;
        scan can mark unstable coronary plaques. For the intermediate risk population who would&#xD;
        demonstrate within 6 to 18 months after first calcium score either an increase of percentile&#xD;
        of more than 20% or an increase above 20 points of the calcium score and for high risk&#xD;
        population, 18F-Na PET scan will be recommended and repeated 6 months later. Secondary&#xD;
        prevention treatment will then be administered in the event of an abnormal examination.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this protocol is to determine the frequency and the mapping of unstable&#xD;
        coronary plaques highlighted by 18F-Na PET in patients at intermediate and high risk, as well&#xD;
        as their evolution under treatment.&#xD;
  &#xD;
        Aside from traditional risk factors collection and related biological assessments, risk&#xD;
        establishment is based on calcium score, a simple non-injected and very little irradiating&#xD;
        scanner which measures coronary calcifications, stigmata of healed atheroma plaques and, as a&#xD;
        rule, non-evolving. Calcium score, which is interpreted according to age, sex and ethnicity,&#xD;
        therefore makes it possible to assign a percentile within the distribution of all the&#xD;
        patients and to classify patients in:&#xD;
  &#xD;
          -  Group I: &quot;absence of atheromatous plaques&quot;: Score 0&#xD;
  &#xD;
          -  Group II: patients generating few plaques (low risk): calcium score above zero and&#xD;
             classifying the patient below the 40th percentile of a similar population;&#xD;
  &#xD;
          -  Group III: patients generating moderate plaques (intermediate risk) with a calcium score&#xD;
             classifying the patient equal or above the 40th percentile and less than the 65th&#xD;
             percentile;&#xD;
  &#xD;
          -  Group IV: patients generating a lot of plaques (high risk): calcium score classifying&#xD;
             the patient equal or above the 65th percentile. These are more likely to be patients who&#xD;
             will come from the cardiology / check-up sector because of a higher probability of&#xD;
             symptoms or of already being treated for primary prevention.&#xD;
  &#xD;
        Study assumptions are:&#xD;
  &#xD;
          -  apart from any hemodynamically significant coronary stenosis, the instability of a&#xD;
             plaque can lead to symptomatic but transient micro-thrombotic phenomena which are&#xD;
             spontaneously (or under the effect of an anti-aggregation/anticoagulation) resorbable.&#xD;
             Regardless of this plaque fate (most frequently scarring, with calcifications, or much&#xD;
             more rarely inaugural acute coronary syndrome and therefore infarction), it is a major&#xD;
             coronary event which must switch the patient from primary prevention to secondary&#xD;
             prevention;&#xD;
  &#xD;
          -  on painful thoracic syndromes that are sufficiently suggestive to require immediately to&#xD;
             rule out an acute coronary syndrome or secondarily myocardial ischemia (angina),&#xD;
             identifying a rapid progression of the coronary involvement (on the basis of calcium&#xD;
             score) or the direct demonstration of plaque instability (by 18F-Na coupled with a CT&#xD;
             scan) is a major cardiovascular prevention endpoint;&#xD;
  &#xD;
          -  in patients consulting for this clinical presentation, determining the frequency of&#xD;
             those with rapid coronary evolution and/or instability of coronary plaque(s) represents&#xD;
             a fundamental preliminary epidemiological study to modify prevention approach of primary&#xD;
             coronary artery disease;&#xD;
  &#xD;
          -  the evaluation by non-invasive coronary imaging of secondary prevention treatment impact&#xD;
             on these same patients initially diagnosed as &quot;rapidly progressive&quot; and/or unstable&#xD;
             would make it possible to consolidate this strategy if it proves to be effective on the&#xD;
             basis of plaque images and clinical follow-up (in terms of events).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">December 2027</completion_date>
    <primary_completion_date type="Anticipated">August 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Unstable coronary plaque evolution description</measure>
      <time_frame>8 months</time_frame>
      <description>Unstable coronary plaque evolution will be described through calcium score variation.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Unstable coronary plaque evolution description</measure>
      <time_frame>8 months</time_frame>
      <description>Unstable coronary plaque evolution will be described through coro-scanner anatomical variations (targets, sizes, density, remodeling and morphological aspect, surface and diameter of stenosis).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Unstable coronary plaque evolution description</measure>
      <time_frame>8 months</time_frame>
      <description>Unstable coronary plaque evolution will be described through 18F-Na PET scan binding variations (targets, SUVmax and SUVmax ratio on blood activity).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Effectiveness of primary cardiovascular prevention strategy initiation by the care team</measure>
      <time_frame>24 months</time_frame>
      <description>Evaluation at study end of the number of patients having entered the monitoring system, the number of patients with signs of coronary involvement and percentage of patients with coronary progression criteria.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comparison of study cohort symptoms evolution to the symptoms evolution of an historical local cohort with comparable symptomatology which motivated the implementation of a &quot;secondary prevention type&quot; treatment</measure>
      <time_frame>24 months</time_frame>
      <description>The number of persistent symptoms increasing and leading to the prescription of new tests (based on clinical management and good practices) and the number of symptoms having completely disappeared will be compared between the study cohort and the local historical one.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compare, between study cohort and historical cohort, the rate of occurrence of cardiovascular events of interest</measure>
      <time_frame>24 months</time_frame>
      <description>Number of following cardiovascular events will be presented:&#xD;
  angina proved by biology, ECG and functional and/or anatomical imaging,&#xD;
  coronary revascularization in the territory of the unstable plaque if it is individualized or any revascularization (angioplasty or bypass),&#xD;
  myocardial infarction,&#xD;
  occurrence of a ventricular arrhythmia,&#xD;
  cardiovascular death.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Atherosclerosis</condition>
    <arm_group>
      <arm_group_label>Patients of groups III and IV</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients who are categorized after calcium score determination as presenting an intermediate risk to produce atheromatous plaques (group III : between the 40th percentile and the 65th percentile) or presenting a high risk to produce such plaques (group IV: &gt;65th percentile).</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>18F-Na PET Scan</intervention_name>
      <description>For the intermediate risk population who would demonstrate within 6 to 18 months after first calcium score either an increase of percentile of more than 20% or an increase above 20 points of the calcium score and for high risk population, 18F-Na PET scan will be recommended and repeated 6 months later. Secondary prevention treatment will then be administered in the event of an abnormal examination.</description>
      <arm_group_label>Patients of groups III and IV</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient with no coronary history presenting to the emergency room, to the assessment&#xD;
               unit or having consulted in the cardiology department for suspicious chest pain that&#xD;
               does not allow an acute coronary syndrome or angina to be excluded and:&#xD;
  &#xD;
                 -  in whom the diagnosis of acute coronary syndrome has been ruled out on the basis&#xD;
                    of clinical, electrocardiographic, biological monitoring, or even by imaging&#xD;
                    (including coronary angiography), in accordance with recommendations and good&#xD;
                    practices&#xD;
  &#xD;
                 -  in whom effort myocardial ischemia is rendered unlikely on the basis of a&#xD;
                    clinical and paraclinical evaluation (either ergometric or by functional imaging:&#xD;
                    scintigraphy, echography or stress MRI)&#xD;
  &#xD;
                 -  wishing diagnostic care and primary prevention of coronary disease.&#xD;
  &#xD;
            -  Age strictly above 45 and strictly below 80 years old&#xD;
  &#xD;
            -  Having given informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant woman&#xD;
  &#xD;
            -  Patient with cognitive disorders&#xD;
  &#xD;
            -  Claustrophobic patient, or refusing radiological examinations&#xD;
  &#xD;
            -  Patient refusing cardiological follow-up and/or treatment of his risk factors or&#xD;
               refusing to participate in the study&#xD;
  &#xD;
            -  Patient with contraindications or intolerances:&#xD;
  &#xD;
                 -  to preventive anti-aggregation (aspirin 75 to 100 mg/day),&#xD;
  &#xD;
                 -  to HMG-CoA reductase inhibitors (statins) and/or Ezetimibe&#xD;
  &#xD;
            -  Patient with liver failure&#xD;
  &#xD;
            -  Patient with myopathy or with a history of (rhabdo)myolysis&#xD;
  &#xD;
            -  Marked arrhythmia and in particular supraventricular or ventricular hyperexcitability,&#xD;
               or chronic or paroxysmal atrial fibrillation not controlled by antiarrhythmic&#xD;
               treatment&#xD;
  &#xD;
            -  Patients with a history of sternotomy or valve replacement or metallic intracardiac&#xD;
               probes, generators of scanner artefacts&#xD;
  &#xD;
            -  Calcium score corresponding to the percentiles of groups I and II&#xD;
  &#xD;
            -  For patients in groups III and IV:&#xD;
  &#xD;
                 -  renal insufficiency with glomerular filtration rate estimated by the MDRD and/or&#xD;
                    CKD-EPI formula less than or equal to 55 ml/min/1.73 m2,&#xD;
  &#xD;
                 -  known intolerance to radiological contrast products, or in whom a CT scan has&#xD;
                    already been performed in the 6 months preceding inclusion&#xD;
  &#xD;
            -  Person participating in another biomedical research&#xD;
  &#xD;
            -  Person under judicial protection (guardianship, curatorship...)&#xD;
  &#xD;
            -  Person deprived of liberty by a judicial or administrative decision.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>46 Years</minimum_age>
      <maximum_age>79 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Marc FARAGGI, MD-PhD</last_name>
      <role>Study Director</role>
      <affiliation>Centre Hospitalier Princesse Grace</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Asmaa JOBIC</last_name>
      <phone>04 83 77 20 61</phone>
      <phone_ext>+33</phone_ext>
      <email>asmaa.jobic@ch-toulon.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Centre Hospitalier Princesse Grace</name>
        <address>
          <city>Monaco</city>
          <zip>98000</zip>
          <country>Monaco</country>
        </address>
      </facility>
      <contact>
        <last_name>Marc FARAGGI, MD-PhD</last_name>
        <phone>97 98 96 59</phone>
        <phone_ext>+377</phone_ext>
        <email>marc.faraggi@chpg.mc</email>
      </contact>
    </location>
    <location_countries>
      <country>Monaco</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Atherosclerotic plaques</keyword>
    <keyword>Acute coronary syndrome</keyword>
    <keyword>18F-Na PET</keyword>
    <keyword>Coronary Artery Calcification Score</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Coronary Artery Disease</mesh_term>
      <mesh_term>Myocardial Ischemia</mesh_term>
      <mesh_term>Coronary Disease</mesh_term>
      <mesh_term>Atherosclerosis</mesh_term>
      <mesh_term>Emergencies</mesh_term>
      <mesh_term>Chest Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013722
  org study id: 2023-CHITS-007
  nct id: NCT06013722
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Primary prevention of coronary disease and especially its major complication, inaugural
        myocardial infarction, is based on any prodromal symptoms identification and on risk profile
        establishment. About 50% of myocardial infarctions are caused by an unstable non-stenosing
        plaque, asymptomatic before the event since without significant reduction in coronary flow,
        particularly during a stress test or during stress imaging.
  
        Study purpose is to set up, in medical emergency department, check-up unit and cardiology
        department, a primary prevention strategy articulated around a routine examination: calcium
        scoring. The latter makes it possible to categorize patients according to their risk of
        generating atheromatous plaques and to classify them into several risk levels (groups)
        according to their score: low (<40th percentile), intermediate (between the 40th percentile
        and the 65th percentile: group III) or high risk (>65th percentile, group IV). 18F-Na PET
        scan can mark unstable coronary plaques. For the intermediate risk population who would
        demonstrate within 6 to 18 months after first calcium score either an increase of percentile
        of more than 20% or an increase above 20 points of the calcium score and for high risk
        population, 18F-Na PET scan will be recommended and repeated 6 months later. Secondary
        prevention treatment will then be administered in the event of an abnormal examination.
  The purpose of this protocol is to determine the frequency and the mapping of unstable
        coronary plaques highlighted by 18F-Na PET in patients at intermediate and high risk, as well
        as their evolution under treatment.
  
        Aside from traditional risk factors collection and related biological assessments, risk
        establishment is based on calcium score, a simple non-injected and very little irradiating
        scanner which measures coronary calcifications, stigmata of healed atheroma plaques and, as a
        rule, non-evolving. Calcium score, which is interpreted according to age, sex and ethnicity,
        therefore makes it possible to assign a percentile within the distribution of all the
        patients and to classify patients in:
  
          -  Group I: "absence of atheromatous plaques": Score 0
  
          -  Group II: patients generating few plaques (low risk): calcium score above zero and
             classifying the patient below the 40th percentile of a similar population;
  
          -  Group III: patients generating moderate plaques (intermediate risk) with a calcium score
             classifying the patient equal or above the 40th percentile and less than the 65th
             percentile;
  
          -  Group IV: patients generating a lot of plaques (high risk): calcium score classifying
             the patient equal or above the 65th percentile. These are more likely to be patients who
             will come from the cardiology / check-up sector because of a higher probability of
             symptoms or of already being treated for primary prevention.
  
        Study assumptions are:
  
          -  apart from any hemodynamically significant coronary stenosis, the instability of a
             plaque can lead to symptomatic but transient micro-thrombotic phenomena which are
             spontaneously (or under the effect of an anti-aggregation/anticoagulation) resorbable.
             Regardless of this plaque fate (most frequently scarring, with calcifications, or much
             more rarely inaugural acute coronary syndrome and therefore infarction), it is a major
             coronary event which must switch the patient from primary prevention to secondary
             prevention;
  
          -  on painful thoracic syndromes that are sufficiently suggestive to require immediately to
             rule out an acute coronary syndrome or secondarily myocardial ischemia (angina),
             identifying a rapid progression of the coronary involvement (on the basis of calcium
             score) or the direct demonstration of plaque instability (by 18F-Na coupled with a CT
             scan) is a major cardiovascular prevention endpoint;
  
          -  in patients consulting for this clinical presentation, determining the frequency of
             those with rapid coronary evolution and/or instability of coronary plaque(s) represents
             a fundamental preliminary epidemiological study to modify prevention approach of primary
             coronary artery disease;
  
          -  the evaluation by non-invasive coronary imaging of secondary prevention treatment impact
             on these same patients initially diagnosed as "rapidly progressive" and/or unstable
             would make it possible to consolidate this strategy if it proves to be effective on the
             basis of plaque images and clinical follow-up (in terms of events).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Unstable coronary plaque evolution description
  time frame: 8 months
  description: Unstable coronary plaque evolution will be described through calcium score variation.
  measure: Unstable coronary plaque evolution description
  time frame: 8 months
  description: Unstable coronary plaque evolution will be described through coro-scanner anatomical variations (targets, sizes, density, remodeling and morphological aspect, surface and diameter of stenosis).
  measure: Unstable coronary plaque evolution description
  time frame: 8 months
  description: Unstable coronary plaque evolution will be described through 18F-Na PET scan binding variations (targets, SUVmax and SUVmax ratio on blood activity).
  measure: Effectiveness of primary cardiovascular prevention strategy initiation by the care team
  time frame: 24 months
  description: Evaluation at study end of the number of patients having entered the monitoring system, the number of patients with signs of coronary involvement and percentage of patients with coronary progression criteria.
  measure: Comparison of study cohort symptoms evolution to the symptoms evolution of an historical local cohort with comparable symptomatology which motivated the implementation of a "secondary prevention type" treatment
  time frame: 24 months
  description: The number of persistent symptoms increasing and leading to the prescription of new tests (based on clinical management and good practices) and the number of symptoms having completely disappeared will be compared between the study cohort and the local historical one.
  measure: Compare, between study cohort and historical cohort, the rate of occurrence of cardiovascular events of interest
  time frame: 24 months
  description: Number of following cardiovascular events will be presented:
  angina proved by biology, ECG and functional and/or anatomical imaging,
  coronary revascularization in the territory of the unstable plaque if it is individualized or any revascularization (angioplasty or bypass),
  myocardial infarction,
  occurrence of a ventricular arrhythmia,
  cardiovascular death.
  arm group label: Patients of groups III and IV
  arm group type: Experimental
  description: Patients who are categorized after calcium score determination as presenting an intermediate risk to produce atheromatous plaques (group III : between the 40th percentile and the 65th percentile) or presenting a high risk to produce such plaques (group IV: >65th percentile).
  intervention type: Diagnostic Test
  intervention name: 18F-Na PET Scan
  description: For the intermediate risk population who would demonstrate within 6 to 18 months after first calcium score either an increase of percentile of more than 20% or an increase above 20 points of the calcium score and for high risk population, 18F-Na PET scan will be recommended and repeated 6 months later. Secondary prevention treatment will then be administered in the event of an abnormal examination.
  arm group label: Patients of groups III and IV
  criteria: 
  gender: All
  minimum age: 46 Years
  maximum age: 79 Years
  healthy volunteers: No
  last name: Marc FARAGGI, MD-PhD
  role: Study Director
  affiliation: Centre Hospitalier Princesse Grace
  last name: Asmaa JOBIC
  phone: 04 83 77 20 61
  phone ext: +33
  email: asmaa.jobic@ch-toulon.fr
  facility: 
  contact: 
  country: Monaco
  responsible party type: Sponsor
  mesh term: Coronary Artery Disease
  mesh term: Myocardial Ischemia
  mesh term: Coronary Disease
  mesh term: Atherosclerosis
  mesh term: Emergencies
  mesh term: Chest Pain
  sharing ipd: No