<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/NCT04496687</url>
  </required_header>
  <id_info>
    <org_study_id>20190308</org_study_id>
    <nct_id>NCT04496687</nct_id>
  </id_info>
  <brief_title>International Spontaneous Coronary Artery Dissection (SCAD) &quot;iSCAD&quot; Registry</brief_title>
  <official_title>The International Spontaneous Coronary Artery Dissection &quot;iSCAD&quot; Registry (SCAD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SCAD Alliance</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>PERFUSE Study Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>SCAD Alliance</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of &quot;iSCAD,&quot; the International Spontaneous Coronary Artery Dissection (SCAD) Registry,&#xD;
      is to serve as an internationally collaborative, multicenter registry coordinated by an&#xD;
      experienced and centralized coordinating center in an effort to increase the pace of&#xD;
      participant recruitment, and thereby increase statistical power of studies related to SCAD.&#xD;
&#xD;
      The ultimate goal of iSCAD Registry is to facilitate the development of best practices and&#xD;
      clinical guidelines for preventing SCAD or its recurrence. This observational study will be&#xD;
      prospective and retrospective in its recruitment and will collect clinical information to&#xD;
      better understand the natural history and prognosis for SCAD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Spontaneous Coronary Artery Dissection (SCAD) is an under-diagnosed cause of acute coronary&#xD;
      syndrome (ACS), myocardial infarction (MI) and sudden cardiac arrest. The inner lining of the&#xD;
      coronary artery splits and allows blood to seep into the adjacent layer, forming a blockage&#xD;
      (hematoma), or the artery continues to tear, creating a flap of tissue that blocks blood flow&#xD;
      in the artery.&#xD;
&#xD;
      SCAD strikes generally healthy, younger individuals (average age 42) who do not have&#xD;
      traditional cardiac risk factors. Warning signs of SCAD encompass the full range of ACS and&#xD;
      MI symptoms, from vague to classic. The cause of SCAD is currently unknown and the&#xD;
      psychosocial impact of SCAD is traumatizing. The work of the iSCAD Registry will encompass&#xD;
      the physical and psychosocial study of SCAD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 8, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>3 Years</target_duration>
  <primary_outcome>
    <measure>Descriptive Data</measure>
    <time_frame>Continuous time frame following index event for an average of 3 years from study contact date</time_frame>
    <description>Participant demographic, historical, clinical characteristics, and treatment data</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Outcomes</measure>
    <time_frame>Continuous time frame following index event for an average of 3 years from study contact date</time_frame>
    <description>Prospectively collected long-term outcomes including recurrent myocardial infarction, hospitalization, heart failure, stroke or transient ischemic attack, arrhythmia, and all cause mortality</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Psychosocial Outcomes</measure>
    <time_frame>Continuous time frame following index event for an average of 3 years from study contact date</time_frame>
    <description>Prospectively collected data on participant's mental health using validated questionnaires</description>
  </primary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Spontaneous Coronary Artery Dissection</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Spontaneous coronary artery dissection (SCAD) is defined as the non-traumatic,&#xD;
        non-iatrogenic separation of the coronary arterial wall by intramural hemorrhage creating a&#xD;
        false lumen, with or without an intimal tear. SCAD nearly always presents as an acute&#xD;
        myocardial infarction. The prevalence of SCAD varies depending on the population studied. A&#xD;
        goal of iSCAD Registry is to expand diversity of race, ethnicity, and sex of study&#xD;
        participants. The mean age of SCAD presentation is 45-53 years of age, and appears to&#xD;
        primarily affect women.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants with a new diagnosis of SCAD or a history of confirmed or suspected SCAD will&#xD;
        be prospectively recruited from either:&#xD;
&#xD;
          1. Inpatient wards of the enrolling medical centers during the acute presentation of&#xD;
             SCAD, or&#xD;
&#xD;
          2. Outpatient cardiovascular clinics of enrolling medical centers.&#xD;
&#xD;
        Participants must be:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Diagnosis of SCAD or history of SCAD based on coronary angiography, either&#xD;
             catheter-based or coronary CTA&#xD;
&#xD;
          -  Suspected SCAD by coronary angiography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Coronary dissection in association with atherosclerosis or as a result of iatrogenic&#xD;
             injury&#xD;
&#xD;
          2. Inability to provide informed consent&#xD;
&#xD;
          3. Inability to complete study-related patient questionnaires&#xD;
&#xD;
          4. Inability to understand and complete patient questionnaires independently&#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>Esther Kim, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Chair, Steering Committee</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Malissa Wood, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Member, Steering Committee</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sahar Naderi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Member, Steering Committee</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Esther Kim, MD, MPH</last_name>
    <phone>704-373-0212</phone>
    <email>Soo.Kim@atriumhealth.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>UCLA (University of California, Los Angeles)</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>93003</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tim Canan, MD</last_name>
      <phone>805-642-6252</phone>
      <email>tcanan@mednet.ucla.edu</email>
    </contact>
    <investigator>
      <last_name>Tim Canan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Northern California</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sahar Naderi, MD</last_name>
      <phone>415-833-2616</phone>
      <email>sahar.naderi@kp.org</email>
    </contact>
    <investigator>
      <last_name>Sahar Naderi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Connie Hess, MD</last_name>
      <email>connie.hess@ucdenver.edu</email>
    </contact>
    <contact_backup>
      <last_name>Kylie Boynton</last_name>
      <email>KYLIE.BOYNTON@CUANSCHUTZ.EDU</email>
    </contact_backup>
    <investigator>
      <last_name>Connie Hess, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hartford Hospital</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephanie Saucier, MD</last_name>
      <email>Stephanie.Saucier@hhchealth.org</email>
    </contact>
    <contact_backup>
      <last_name>Erika Zahina</last_name>
      <email>erika.zahina@hhchealth.org</email>
    </contact_backup>
    <investigator>
      <last_name>Stephanie Saucier, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Erika Zahina, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33602</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniela Crousillat, MD</last_name>
      <email>crousillatd@usf.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Emory Healthcare System</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sydney Derrick</last_name>
      <email>sydney.derrick@emory.edu</email>
    </contact>
    <investigator>
      <last_name>Bryan J Wells, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40508</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jeff Trost, MD</last_name>
      <phone>443-997-0270</phone>
      <email>jtrost2@jhmi.edu</email>
    </contact>
    <contact_backup>
      <last_name>Anum Minhas, MD</last_name>
      <phone>443-997-0270</phone>
      <email>aminhas2@jhmi.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Jeff Trost, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114-2696</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Malissa Wood, MD</last_name>
      <phone>617-726-0995</phone>
      <email>MJWOOD@mgh.harvard.edu</email>
    </contact>
    <contact_backup>
      <last_name>Yousef Ghazzawi</last_name>
      <email>YGHAZZAWI@mgh.harvard.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Malissa Wood, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Luke's Mid America</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anna Grodzinsky, MD</last_name>
      <phone>816-931-1883</phone>
      <email>agrodzinsky@saint-lukes.org</email>
    </contact>
    <contact_backup>
      <last_name>Carmen Butcher</last_name>
      <email>cdbutcher@saint-lukes.org</email>
    </contact_backup>
    <investigator>
      <last_name>Anna Grodzinsky, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stan Henkin, MD</last_name>
      <phone>603-650-5724</phone>
      <email>stanislav.henkin@hitchcock.org</email>
    </contact>
    <contact_backup>
      <last_name>Hannah Ellis</last_name>
      <email>hannah.r.ellis@hitchcock.org</email>
    </contact_backup>
    <investigator>
      <last_name>Stan Henkin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Catholic Medical Center</name>
      <address>
        <city>Manchester</city>
        <state>New Hampshire</state>
        <zip>03102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jaime Makooi</last_name>
      <email>jaime.makooi@cmc-nh.org</email>
    </contact>
    <contact_backup>
      <last_name>Michelle Ouellette, MD</last_name>
      <email>michelle.ouellette@cmc-nh.org</email>
    </contact_backup>
    <investigator>
      <last_name>Michelle Ouellette, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029-6574</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniella Kadian-Dodov, MD</last_name>
      <email>daniella.kadian-dodov@mountsinai.org</email>
    </contact>
    <contact_backup>
      <last_name>Kimberly Capustin</last_name>
      <email>kimberly.capustin@mountsinai.org</email>
    </contact_backup>
    <investigator>
      <last_name>Daniella Kadian-Dodov, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sonia Tolani, MD</last_name>
      <email>st2367@cumc.columbia.edu</email>
    </contact>
    <investigator>
      <last_name>Sonia Tolani, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Atrium Health Sanger Heart and Vascular Institute</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Esther SH Kim, MD, MPH</last_name>
      <phone>704-373-0212</phone>
      <email>Soo.Kim@atriumhealth.org</email>
    </contact>
    <investigator>
      <last_name>Esther SH Kim, MD, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospitals--Case Western</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heather Gornik, MD</last_name>
      <phone>216-250-9714</phone>
      <email>heather.gornik@UHHospitals.org</email>
    </contact>
    <contact_backup>
      <last_name>Nasla Tonni</last_name>
      <email>nazla.tonni@UHHospitals.org</email>
    </contact_backup>
    <investigator>
      <last_name>Heather Gornik, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Oklahoma Heart</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73120</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Richardson</last_name>
      <email>arichardson@okheart.com</email>
    </contact>
    <contact_backup>
      <last_name>Raghav Gupta, MD</last_name>
      <email>rgupta@okheart.com</email>
    </contact_backup>
    <investigator>
      <last_name>Raghav Gupta, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Providence</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97225</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lori Tam, MD</last_name>
      <phone>503-216-2229</phone>
      <email>lori.tam@providence.org</email>
    </contact>
    <contact_backup>
      <last_name>Shawnna Verburg</last_name>
      <email>shawnna.verburg@providence.org</email>
    </contact_backup>
    <investigator>
      <last_name>Lori Tam, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Lewey, MD</last_name>
      <phone>800-789-7366</phone>
      <email>jennifer.lewey@pennmedicine.upenn.edu</email>
    </contact>
    <contact_backup>
      <last_name>Tiffany Sharkosi</last_name>
      <email>sharkosk@pennmedicine.upenn.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Jennifer Lewey, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Agnes Koczo, MD</last_name>
      <email>koczoa@upmc.edu</email>
    </contact>
    <investigator>
      <last_name>Agnes Koczo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Katie Berlacher, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kathryn Lindley, MD</last_name>
      <phone>615-322-3218</phone>
    </contact>
    <contact_backup>
      <last_name>Emily Banks</last_name>
      <email>emily.s.banks@vumc.org</email>
    </contact_backup>
    <investigator>
      <last_name>Kathryn Lindley, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UT Southwestern</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dharam Kumbhani, MD</last_name>
      <phone>214-645-8300</phone>
      <email>dharam.kumbhani@utsouthwestern.edu</email>
    </contact>
    <contact_backup>
      <last_name>Rina Mauricio, MD</last_name>
      <email>rina.mauricio@utsouthwestern.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Dharam Kumbhani, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Intermountain</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>James Orford, MD</last_name>
      <phone>801-507-4701</phone>
      <email>james.orford@imail.org</email>
    </contact>
    <contact_backup>
      <last_name>Lorlie Evans</last_name>
      <email>lorlie.evans@imail.org</email>
    </contact_backup>
    <investigator>
      <last_name>James Orford, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Angela Taylor, MD</last_name>
      <phone>434-243-1000</phone>
      <email>AMT6B@hscmail.mcc.virginia.edu</email>
    </contact>
    <contact_backup>
      <last_name>Shelly Brunk</last_name>
      <email>SLB4P@hscmail.mcc.virginia.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Angela Taylor, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Victor Chang Cardiac Research Institute</name>
      <address>
        <city>Darlinghurst</city>
        <state>New South Wales</state>
        <zip>NSW 2010</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jason C Kovacic, MBBS, PhD</last_name>
      <phone>61 2 9295 8600</phone>
      <email>j.kovacic@victorchang.edu.au]</email>
    </contact>
    <contact_backup>
      <last_name>Stephanie Hessleson, PhD</last_name>
      <phone>61 2 9295 8768</phone>
      <email>S.Hesselson@victorchang.edu.au</email>
    </contact_backup>
    <investigator>
      <last_name>Jason C Kovacic, MBBS, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Robert M Graham, AO, FAA</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://iscadregistry.bidmc.org/index.php/Main_Page</url>
    <description>iSCAD Registry Home Page</description>
  </link>
  <link>
    <url>https://www.scadalliance.org/iscad-registry/</url>
    <description>iSCAD Registry FAQs and sponsor page</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>August 16, 2023</last_update_submitted>
  <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>spontaneous coronary artery dissection (SCAD)</keyword>
  <keyword>myocardial infarction</keyword>
  <keyword>sudden cardiac arrest</keyword>
  <keyword>acute coronary syndrome</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/NCT04496687
org study id: 20190308
nct id: NCT04496687
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The aim of "iSCAD," the International Spontaneous Coronary Artery Dissection (SCAD) Registry,
      is to serve as an internationally collaborative, multicenter registry coordinated by an
      experienced and centralized coordinating center in an effort to increase the pace of
      participant recruitment, and thereby increase statistical power of studies related to SCAD.

      The ultimate goal of iSCAD Registry is to facilitate the development of best practices and
      clinical guidelines for preventing SCAD or its recurrence. This observational study will be
      prospective and retrospective in its recruitment and will collect clinical information to
      better understand the natural history and prognosis for SCAD.
Spontaneous Coronary Artery Dissection (SCAD) is an under-diagnosed cause of acute coronary
      syndrome (ACS), myocardial infarction (MI) and sudden cardiac arrest. The inner lining of the
      coronary artery splits and allows blood to seep into the adjacent layer, forming a blockage
      (hematoma), or the artery continues to tear, creating a flap of tissue that blocks blood flow
      in the artery.

      SCAD strikes generally healthy, younger individuals (average age 42) who do not have
      traditional cardiac risk factors. Warning signs of SCAD encompass the full range of ACS and
      MI symptoms, from vague to classic. The cause of SCAD is currently unknown and the
      psychosocial impact of SCAD is traumatizing. The work of the iSCAD Registry will encompass
      the physical and psychosocial study of SCAD.
observational model: Cohort
time perspective: Other
measure: Descriptive Data
time frame: Continuous time frame following index event for an average of 3 years from study contact date
description: Participant demographic, historical, clinical characteristics, and treatment data
measure: Clinical Outcomes
time frame: Continuous time frame following index event for an average of 3 years from study contact date
description: Prospectively collected long-term outcomes including recurrent myocardial infarction, hospitalization, heart failure, stroke or transient ischemic attack, arrhythmia, and all cause mortality
measure: Psychosocial Outcomes
time frame: Continuous time frame following index event for an average of 3 years from study contact date
description: Prospectively collected data on participant's mental health using validated questionnaires
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Esther Kim, MD
role: Study Chair
affiliation: Chair, Steering Committee
last name: Malissa Wood, MD
role: Principal Investigator
affiliation: Member, Steering Committee
last name: Sahar Naderi, MD
role: Principal Investigator
affiliation: Member, Steering Committee
last name: Esther Kim, MD, MPH
phone: 704-373-0212
email: Soo.Kim@atriumhealth.org
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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facility: 
status: Terminated
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status: Recruiting
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status: Recruiting
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status: Terminated
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
contact: 
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status: Recruiting
contact: 
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status: Recruiting
contact: 
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status: Recruiting
contact: 
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status: Recruiting
contact: 
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status: Recruiting
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status: Recruiting
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investigator: 
country: Australia
country: United States
url: https://iscadregistry.bidmc.org/index.php/Main_Page
description: iSCAD Registry Home Page
url: https://www.scadalliance.org/iscad-registry/
description: iSCAD Registry FAQs and sponsor page
responsible party type: Sponsor
mesh term: Aortic Dissection
mesh term: Coronary Vessel Anomalies
mesh term: Vascular Diseases