<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/NCT03788512</url>
  </required_header>
  <id_info>
    <org_study_id>CoCCA</org_study_id>
    <nct_id>NCT03788512</nct_id>
  </id_info>
  <brief_title>Coexistence of Cerebral and Coronary Atherosclerosis in Acute Ischemic Cerebrovascular Disease Patients Registry</brief_title>
  <acronym>CoCCA</acronym>
  <official_title>Coexistence of Cerebral and Coronary Atherosclerosis in Acute Ischemic Cerebrovascular Disease Patients Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xuanwu Hospital, Beijing</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xuanwu Hospital, Beijing</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>
      Coexistence of Cerebral and Coronary Atherosclerosis in Acute Ischemic Cerebrovascular&#xD;
      Disease Patients Registry (CoCCA) is a single-center observational registry of patients&#xD;
      hospitalized for acute ischemic cerebrovascular disease (AICVD) with atherosclerotic changes&#xD;
      in both cerebral and coronary arteries.&#xD;
&#xD;
      This registry aims to establish quantified risk stratification and prognostic models, as well&#xD;
      as suggest effective diagnostic and therapeutic strategies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Atherosclerosis has exerted huge global burden as the common pathological process underlying&#xD;
      ischemic heart disease and cerebrovascular disease. A substantial portion of acute ischemic&#xD;
      cerebrovascular disease (AICVD) patients have both cerebral and coronary atherosclerosis,&#xD;
      which is an omen of poor outcomes. But there is large evidence gap in these high-risk&#xD;
      patients' prognosis-related factors, limiting the improvement of care quality.&#xD;
&#xD;
      Coexistence of Cerebral and Coronary Atherosclerosis in Acute Ischemic Cerebrovascular&#xD;
      Disease Patients Registry (CoCCA) is a single-center prospective observational registry of&#xD;
      patients hospitalized for AICVD with atherosclerotic changes in both cerebral and coronary&#xD;
      arteries.&#xD;
&#xD;
      This registry aims to establish quantified risk stratification and prognostic models, as well&#xD;
      as suggest effective diagnostic and therapeutic strategies.&#xD;
&#xD;
      The clinical, imaging and laboratory information will be collected at the baseline. During an&#xD;
      estimated 5-year follow-up, the vessel-related diagnostic or monitoring procedures,&#xD;
      treatment, functional status and new vascular events will be recorded by web-based patients'&#xD;
      self-reports, investigators' regular telephone visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 12, 2019</start_date>
  <completion_date type="Anticipated">December 2027</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Rate of Major Adverse Cardiovascular Events</measure>
    <time_frame>1 year</time_frame>
    <description>cardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction and unstable angina</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Major Adverse Cardiovascular Events</measure>
    <time_frame>90 days</time_frame>
    <description>cardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction and unstable angina</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Outcome</measure>
    <time_frame>90 days</time_frame>
    <description>Percentage of patients with modified Rankin Scale (mRS) scores (minimum 0 and maximum 5) 3 to 5, who are considered to be disabled.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Ischemic Stroke</measure>
    <time_frame>1 year</time_frame>
    <description>fatal and nonfatal ischemic stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Acute Coronary Syndrome</measure>
    <time_frame>1 year</time_frame>
    <description>fatal and nonfatal myocardial infarction and unstable angina</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Cardiovascular Mortality</measure>
    <time_frame>1 year</time_frame>
    <description>any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Major Adverse Cardiovascular Event</measure>
    <time_frame>5 years</time_frame>
    <description>from the date of enrollment until the date of first documented cardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction or unstable angina, whichever comes first, assessed up to 5 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Ischemic Stroke</measure>
    <time_frame>5 years</time_frame>
    <description>from the date of enrollment until the date of first documented ischemic stroke, assessed up to 5 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Major Adverse Cardiovascular Events</measure>
    <time_frame>5 years</time_frame>
    <description>cardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction and unstable angina</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Ischemic Stroke</measure>
    <time_frame>5 years</time_frame>
    <description>fatal and nonfatal ischemic stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Acute Coronary Syndrome</measure>
    <time_frame>5 years</time_frame>
    <description>fatal and nonfatal myocardial infarction and unstable angina</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Cardiovascular Mortality</measure>
    <time_frame>5 years</time_frame>
    <description>any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Coexistence of Cerebral and Coronary Atherosclerosis</condition>
  <condition>Acute Ischemic Cerebrovascular Disease</condition>
  <arm_group>
    <arm_group_label>AICVD patients with CoCCA</arm_group_label>
    <description>acute ischemic cerebrovascular disease patients with coexistence of cerebral and coronary atherosclerosis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>observational only- no intervention</intervention_name>
    <description>observational only- no intervention</description>
    <arm_group_label>AICVD patients with CoCCA</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      anticoagulant peripheral blood, serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        acute ischemic cerebrovascular disease patients with coexistence of cerebral and coronary&#xD;
        atherosclerosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosed as ischemic stroke or transient ischemic attack (TIA).&#xD;
&#xD;
          2. Less than 30 days after onset of ischemic stroke or TIA symptoms.&#xD;
&#xD;
          3. Extracranial or intracranial cerebral atherosclerosis confirmed by vascular ultrasound&#xD;
             or CT angiograpgy or MR angiograpgy or digital substraction angiography.&#xD;
&#xD;
          4. Coronary atherosclerosis confirmed by CT angiograpgy or MR angiograpgy or digital&#xD;
             substraction angiography; or with myocardial ischemia symptoms confirmed using&#xD;
             electrocardiogram or echocardiography or cardiac MR; or with a history of percutaneous&#xD;
             coronary intervention or coronary artery bypass graft.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. With malignant tumors or poor organ functions or hematologic diseases, whose estimated&#xD;
             life expectancy is less than 5 years.&#xD;
&#xD;
          2. Patients refuse to participate in the research.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Xin Ma, MD, PhD</last_name>
    <phone>13501390691</phone>
    <email>maxin118@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Xuanwu Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xin Ma, MD, PhD</last_name>
      <phone>13501390691</phone>
      <email>maxin118@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 25, 2018</study_first_submitted>
  <study_first_submitted_qc>December 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>January 7, 2022</last_update_submitted>
  <last_update_submitted_qc>January 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xuanwu Hospital, Beijing</investigator_affiliation>
    <investigator_full_name>Xin Ma</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>acute ischemic cerebrovascular disease</keyword>
  <keyword>cerebral atherosclerosis</keyword>
  <keyword>coronary atherosclerosis</keyword>
  <keyword>coexistence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebrovascular Disorders</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Ischemia</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/NCT03788512
org study id: CoCCA
nct id: NCT03788512
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Coexistence of Cerebral and Coronary Atherosclerosis in Acute Ischemic Cerebrovascular
      Disease Patients Registry (CoCCA) is a single-center observational registry of patients
      hospitalized for acute ischemic cerebrovascular disease (AICVD) with atherosclerotic changes
      in both cerebral and coronary arteries.

      This registry aims to establish quantified risk stratification and prognostic models, as well
      as suggest effective diagnostic and therapeutic strategies.
Atherosclerosis has exerted huge global burden as the common pathological process underlying
      ischemic heart disease and cerebrovascular disease. A substantial portion of acute ischemic
      cerebrovascular disease (AICVD) patients have both cerebral and coronary atherosclerosis,
      which is an omen of poor outcomes. But there is large evidence gap in these high-risk
      patients' prognosis-related factors, limiting the improvement of care quality.

      Coexistence of Cerebral and Coronary Atherosclerosis in Acute Ischemic Cerebrovascular
      Disease Patients Registry (CoCCA) is a single-center prospective observational registry of
      patients hospitalized for AICVD with atherosclerotic changes in both cerebral and coronary
      arteries.

      This registry aims to establish quantified risk stratification and prognostic models, as well
      as suggest effective diagnostic and therapeutic strategies.

      The clinical, imaging and laboratory information will be collected at the baseline. During an
      estimated 5-year follow-up, the vessel-related diagnostic or monitoring procedures,
      treatment, functional status and new vascular events will be recorded by web-based patients'
      self-reports, investigators' regular telephone visits.
observational model: Cohort
time perspective: Prospective
measure: Rate of Major Adverse Cardiovascular Events
time frame: 1 year
description: cardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction and unstable angina
measure: Rate of Major Adverse Cardiovascular Events
time frame: 90 days
description: cardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction and unstable angina
measure: Functional Outcome
time frame: 90 days
description: Percentage of patients with modified Rankin Scale (mRS) scores (minimum 0 and maximum 5) 3 to 5, who are considered to be disabled.
measure: Rate of Ischemic Stroke
time frame: 1 year
description: fatal and nonfatal ischemic stroke.
measure: Rate of Acute Coronary Syndrome
time frame: 1 year
description: fatal and nonfatal myocardial infarction and unstable angina
measure: Rate of Cardiovascular Mortality
time frame: 1 year
description: any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death
measure: Time to First Major Adverse Cardiovascular Event
time frame: 5 years
description: from the date of enrollment until the date of first documented cardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction or unstable angina, whichever comes first, assessed up to 5 years
measure: Time to First Ischemic Stroke
time frame: 5 years
description: from the date of enrollment until the date of first documented ischemic stroke, assessed up to 5 years
measure: Rate of Major Adverse Cardiovascular Events
time frame: 5 years
description: cardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction and unstable angina
measure: Rate of Ischemic Stroke
time frame: 5 years
description: fatal and nonfatal ischemic stroke
measure: Rate of Acute Coronary Syndrome
time frame: 5 years
description: fatal and nonfatal myocardial infarction and unstable angina
measure: Rate of Cardiovascular Mortality
time frame: 5 years
description: any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death
arm group label: AICVD patients with CoCCA
description: acute ischemic cerebrovascular disease patients with coexistence of cerebral and coronary atherosclerosis.
intervention type: Other
intervention name: observational only- no intervention
description: observational only- no intervention
arm group label: AICVD patients with CoCCA
anticoagulant peripheral blood, serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Xin Ma, MD, PhD
phone: 13501390691
email: maxin118@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Xuanwu Hospital, Beijing
investigator full name: Xin Ma
investigator title: Principal investigator
mesh term: Cerebrovascular Disorders
mesh term: Atherosclerosis
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Ischemia