<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/NCT04415762</url>
  </required_header>
  <id_info>
    <org_study_id>001-2020</org_study_id>
    <nct_id>NCT04415762</nct_id>
  </id_info>
  <brief_title>Spontaneous Coronary Artery Dissection Registry (DIssezioni Spontanee COronariche ITalian-SPAnish)</brief_title>
  <acronym>DISCO-IT/SPA</acronym>
  <official_title>A Multicenter Italian and Spanish Observational Registry on Patients Affected by Spontaneous Coronary Artery Dissection (SCAD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>San Luigi Gonzaga Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>San Luigi Gonzaga Hospital</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 study will investigate the clinical features, acute management and follow up of patients&#xD;
      affected by spontaneous coronary artery dissection&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Spontaneous Coronary Artery Dissection is now being increasingly studied as it is getting&#xD;
      more and more relevant as a cause of ACS. Its management is currently a matter of debate due&#xD;
      to the absence of RCT and even the trigger events related to this kind of infarction are&#xD;
      still unclear. Notably, the benefits from the use of the antiplatelet medications that&#xD;
      prolong bleeding time for a condition whose primary pathophysiology may be an intramural&#xD;
      bleed are under discussion.&#xD;
&#xD;
      Hence, the targets pursued by our study may be essentially distinguished in five main points:&#xD;
&#xD;
        1. To assess the characteristics of SCAD patients highlighting the predisposing and&#xD;
           precipitating factors related to the acute event&#xD;
&#xD;
        2. To analyze clinical presentation and management of spontaneous coronary dissections in&#xD;
           terms of therapeutic approach in the acute phase (conservative therapy vs&#xD;
           revascularization)&#xD;
&#xD;
        3. To evaluate the incidence of SCAD recurrence and of major adverse cardiovascular events&#xD;
           (MACEs) at follow-up&#xD;
&#xD;
        4. To analyze the impact of a single antiplatelet therapy (SAPT) over the dual one (DAPT)&#xD;
           along with the impact of different P2Y12i regimens on acute and long-term prognosis&#xD;
&#xD;
        5. To evaluate impact of different angiographic SCAD type on outcome&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2009</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Major Cardiovascular Cardiac Events (a composite of all-cause of death, non-fatal Myocardial Infarction (MI) and any unplanned revascularization either percutaneous or surgical)</measure>
    <time_frame>12 months</time_frame>
    <description>Major Cardiovascular Cardiac Events occurring within 12 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>all-cause of death</measure>
    <time_frame>12 months</time_frame>
    <description>all-cause of death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>non-fatal Myocardial Infarction (MI)</measure>
    <time_frame>12 months</time_frame>
    <description>non-fatal Myocardial Infarction (MI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>any unplanned revascularization either percutaneous or surgical</measure>
    <time_frame>12 months</time_frame>
    <description>any unplanned revascularization either percutaneous or surgical</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Major Cardiovascular Cardiac Events (a composite of all-cause of death, non-fatal Myocardial Infarction (MI) and any unplanned revascularization either percutaneous or surgical) in Single vs Double Antiplatelets therapies in conservatively treated SCAD</measure>
    <time_frame>12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Major Cardiovascular Cardiac Events (a composite of all-cause of death, non-fatal Myocardial Infarction (MI) and any unplanned revascularization either percutaneous or surgical) in Medical treatment vs PCI treated SCAD</measure>
    <time_frame>12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Major Cardiovascular Cardiac Events (a composite of all-cause of death, non-fatal Myocardial Infarction (MI) and any unplanned revascularization either percutaneous or surgical) in different angiographics SCAD type.</measure>
    <time_frame>12 months</time_frame>
  </other_outcome>
  <enrollment type="Actual">314</enrollment>
  <condition>Spontaneous Coronary Artery Dissection</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients with a novel diagnosis of Spontaneous Coronary Artery Dissection&#xD;
        (SCAD) confirmed by core-lab analysis of coronary angiograms and other intravascular&#xD;
        imaging available&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive patients with a novel diagnosis of Spontaneous Coronary Artery Dissection&#xD;
             (SCAD)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 year old or inability to provide Informed Consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Enrico Cerrato, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Luigi Gonzaga University Hospital, Orbassano,Turin, Italy</affiliation>
  </overall_official>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 31, 2020</last_update_submitted>
  <last_update_submitted_qc>May 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>San Luigi Gonzaga Hospital</investigator_affiliation>
    <investigator_full_name>Enrico Cerrato</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Spontaneous coronary artery dissection</keyword>
  <keyword>SCAD</keyword>
  <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>
  <!-- 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/NCT04415762
org study id: 001-2020
nct id: NCT04415762
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will investigate the clinical features, acute management and follow up of patients
      affected by spontaneous coronary artery dissection
Spontaneous Coronary Artery Dissection is now being increasingly studied as it is getting
      more and more relevant as a cause of ACS. Its management is currently a matter of debate due
      to the absence of RCT and even the trigger events related to this kind of infarction are
      still unclear. Notably, the benefits from the use of the antiplatelet medications that
      prolong bleeding time for a condition whose primary pathophysiology may be an intramural
      bleed are under discussion.

      Hence, the targets pursued by our study may be essentially distinguished in five main points:

        1. To assess the characteristics of SCAD patients highlighting the predisposing and
           precipitating factors related to the acute event

        2. To analyze clinical presentation and management of spontaneous coronary dissections in
           terms of therapeutic approach in the acute phase (conservative therapy vs
           revascularization)

        3. To evaluate the incidence of SCAD recurrence and of major adverse cardiovascular events
           (MACEs) at follow-up

        4. To analyze the impact of a single antiplatelet therapy (SAPT) over the dual one (DAPT)
           along with the impact of different P2Y12i regimens on acute and long-term prognosis

        5. To evaluate impact of different angiographic SCAD type on outcome
observational model: Cohort
time perspective: Retrospective
measure: Major Cardiovascular Cardiac Events (a composite of all-cause of death, non-fatal Myocardial Infarction (MI) and any unplanned revascularization either percutaneous or surgical)
time frame: 12 months
description: Major Cardiovascular Cardiac Events occurring within 12 months
measure: all-cause of death
time frame: 12 months
description: all-cause of death
measure: non-fatal Myocardial Infarction (MI)
time frame: 12 months
description: non-fatal Myocardial Infarction (MI)
measure: any unplanned revascularization either percutaneous or surgical
time frame: 12 months
description: any unplanned revascularization either percutaneous or surgical
measure: Major Cardiovascular Cardiac Events (a composite of all-cause of death, non-fatal Myocardial Infarction (MI) and any unplanned revascularization either percutaneous or surgical) in Single vs Double Antiplatelets therapies in conservatively treated SCAD
time frame: 12 months
measure: Major Cardiovascular Cardiac Events (a composite of all-cause of death, non-fatal Myocardial Infarction (MI) and any unplanned revascularization either percutaneous or surgical) in Medical treatment vs PCI treated SCAD
time frame: 12 months
measure: Major Cardiovascular Cardiac Events (a composite of all-cause of death, non-fatal Myocardial Infarction (MI) and any unplanned revascularization either percutaneous or surgical) in different angiographics SCAD type.
time frame: 12 months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Enrico Cerrato, MD
role: Principal Investigator
affiliation: San Luigi Gonzaga University Hospital, Orbassano,Turin, Italy
responsible party type: Principal Investigator
investigator affiliation: San Luigi Gonzaga Hospital
investigator full name: Enrico Cerrato
investigator title: Principal Investigator
mesh term: Aortic Dissection
mesh term: Coronary Vessel Anomalies
mesh term: Vascular Diseases