<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/NCT04457544</url>
  </required_header>
  <id_info>
    <org_study_id>2019-01886</org_study_id>
    <nct_id>NCT04457544</nct_id>
  </id_info>
  <brief_title>Spontaneous Coronary Artery Dissection National Swiss Registry</brief_title>
  <acronym>SwissSCAD</acronym>
  <official_title>Spontaneous Coronary Artery Dissection (SCAD) National Swiss Registry (SwissSCAD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Sophie Degrauwe</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Geneva</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>
      Spontaneous coronary artery dissection (SCAD), is an underdiagnosed pathology, affecting&#xD;
      predominantly young women without traditional cardiovascular risk factors and is associated&#xD;
      with major adverse outcomes including myocardial infarction, cardiac arrest, or death.&#xD;
&#xD;
      Timely diagnosis of SCAD as well as clinical follow-up are of the essence in this pathology&#xD;
      associated with major cardiac adverse outcomes. Despite recent improvements in diagnosis and&#xD;
      recognition of the importance of SCAD, it remains poorly studied and understood.&#xD;
&#xD;
      In this context, we designed the SwissSCAD registry, a large, observational, prospective,&#xD;
      cohort study, to describe the natural history of SCAD, its outcomes and its treatments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 12, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2030</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Incidence of safety events at 30 days</measure>
    <time_frame>30 days</time_frame>
    <description>Incidence of Major cardiovascular outcomes (MACE) at 30 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of safety events at 1 year</measure>
    <time_frame>1 year</time_frame>
    <description>Incidence of Major cardiovascular outcomes (MACE) at 1 year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of safety events at 5 years</measure>
    <time_frame>5 years</time_frame>
    <description>Incidence of Major cardiovascular outcomes (MACE) at 5 years</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Spontaneous Coronary Artery Dissection</condition>
  <arm_group>
    <arm_group_label>Retrospective patients</arm_group_label>
    <description>The investigators will review the hospital records at the investigational site for SCAD events having occurred over the last 5 years. All SCAD patients aged ≥18 years, not presenting atherosclerotic or iatrogenic coronary dissection will be informed about the SwissSCAD study by phone and will be given at least one week to decide if they wish to participate. We plan to include 500 patients in the retrospective arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prospective patients</arm_group_label>
    <description>Patients presenting at the hospital with newly diagnosed SCAD will be informed of the SwissSCAD study and will be given at least one week to decide if they wish to participate. We plan to include 500 patients in the prospective arm.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        This observational study will recruit consecutive male and female patients presenting with&#xD;
        newly diagnosed SCAD or having been diagnosed with SCAD within the last 5 years.&#xD;
&#xD;
        For the purposes of study inclusion, the definition of SCAD will be based on a central&#xD;
        review of the coronary angiographic images confirmed by 2 independent assessors&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is ≥18 years of age.&#xD;
&#xD;
          -  Patient presenting newly diagnosed SCAD or diagnosed with SCAD within the last 5&#xD;
             years.&#xD;
&#xD;
          -  Subject must be willing to sign a Patient Informed Consent (PIC).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient unwilling or unable to provide informed consent.&#xD;
&#xD;
          -  Patients with atherosclerotic or iatrogenic coronary dissection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Sophie Degrauwe, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hopitaux universitaires de Geneve</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sophie Degrauwe, Dr</last_name>
    <phone>+41795530294</phone>
    <email>sophie.degrauwe@hcuge.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Veronique Menoni, PhD</last_name>
    <phone>+41795530917</phone>
    <email>Veronique.Menoni@hcuge.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Geneva University Hospitals</name>
      <address>
        <city>Geneva</city>
        <zip>1205</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sophie Degrauwe, MD</last_name>
      <email>sophie.degrauwe@hcuge.ch</email>
    </contact>
    <contact_backup>
      <last_name>Véronique Menoni</last_name>
      <email>veronique.menoni@hcuge.ch</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>November 13, 2022</last_update_submitted>
  <last_update_submitted_qc>November 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Dr. Sophie Degrauwe</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Dissection</mesh_term>
    <mesh_term>Coronary Vessel Anomalies</mesh_term>
    <mesh_term>Vascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04457544
org study id: 2019-01886
nct id: NCT04457544
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Spontaneous coronary artery dissection (SCAD), is an underdiagnosed pathology, affecting
      predominantly young women without traditional cardiovascular risk factors and is associated
      with major adverse outcomes including myocardial infarction, cardiac arrest, or death.

      Timely diagnosis of SCAD as well as clinical follow-up are of the essence in this pathology
      associated with major cardiac adverse outcomes. Despite recent improvements in diagnosis and
      recognition of the importance of SCAD, it remains poorly studied and understood.

      In this context, we designed the SwissSCAD registry, a large, observational, prospective,
      cohort study, to describe the natural history of SCAD, its outcomes and its treatments.
observational model: Cohort
time perspective: Other
measure: Incidence of safety events at 30 days
time frame: 30 days
description: Incidence of Major cardiovascular outcomes (MACE) at 30 days
measure: Incidence of safety events at 1 year
time frame: 1 year
description: Incidence of Major cardiovascular outcomes (MACE) at 1 year
measure: Incidence of safety events at 5 years
time frame: 5 years
description: Incidence of Major cardiovascular outcomes (MACE) at 5 years
arm group label: Retrospective patients
description: The investigators will review the hospital records at the investigational site for SCAD events having occurred over the last 5 years. All SCAD patients aged ≥18 years, not presenting atherosclerotic or iatrogenic coronary dissection will be informed about the SwissSCAD study by phone and will be given at least one week to decide if they wish to participate. We plan to include 500 patients in the retrospective arm.
arm group label: Prospective patients
description: Patients presenting at the hospital with newly diagnosed SCAD will be informed of the SwissSCAD study and will be given at least one week to decide if they wish to participate. We plan to include 500 patients in the prospective arm.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Sophie Degrauwe, Dr
role: Principal Investigator
affiliation: Hopitaux universitaires de Geneve
last name: Sophie Degrauwe, Dr
phone: +41795530294
email: sophie.degrauwe@hcuge.ch
last name: Veronique Menoni, PhD
phone: +41795530917
email: Veronique.Menoni@hcuge.ch
facility: 
status: Recruiting
contact: 
contact backup: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Dr. Sophie Degrauwe
investigator title: Doctor
mesh term: Aortic Dissection
mesh term: Coronary Vessel Anomalies
mesh term: Vascular Diseases
sharing ipd: Undecided