<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/NCT03281590</url>
  </required_header>
  <id_info>
    <org_study_id>17-281</org_study_id>
    <nct_id>NCT03281590</nct_id>
  </id_info>
  <brief_title>Stroke and Cerebrovascular Diseases Registry</brief_title>
  <official_title>Stroke and Cerebrovascular Diseases Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of New Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of New Mexico</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>
      This is a single institutional registry database for the patients with stroke and&#xD;
      cerebrovascular diseases. Stroke is the fifth leading cause of death in the United States.&#xD;
      Despite extensive research, most of the patients die or suffer from varying degree of&#xD;
      post-stroke disabilities due to neurologic deficits. This registry aims to understand the&#xD;
      disease and examine the disease dynamics in the local community.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stroke is the fifth cause of all-cause mortality in US http://www.cdc.gov/stroke/facts.htm&#xD;
      Early identification and treatment not only prevent mortality but also morbidity. Recent&#xD;
      advancement in the imaging and diagnostic technique and novel therapeutic modalities has&#xD;
      dramatically helped to downgrade stroke from the list of top mortality index in the last 3&#xD;
      years. However, studies determining factors which help predict stroke outcome are still&#xD;
      underway and much work needs to be done in this direction. Many factors currently are used to&#xD;
      predict stroke outcome with varying results, for e.g. NIHSS is a good predictor of stroke&#xD;
      outcome at 3 months; however, the investigators need better predictors, outcome scales or&#xD;
      outcome measures which are easy, reliable and has better specificity and sensitivity.&#xD;
&#xD;
      Acute Brain injury, Transient Ischemic Attack is a special category of a neurological&#xD;
      condition wherein there is an impending devastating outcome if workup is not completed in a&#xD;
      timely fashion. There is an urgent need to do investigations with high-risk patients to&#xD;
      prevent stroke and further mortality and morbidity. The abcd2 score can help us to risk&#xD;
      stratify the TIA and to predict the chances of stroke in this specific cohort. However,&#xD;
      investigators need better identifiers than already present, to improve the patient changes in&#xD;
      secondary prophylaxis of stroke prevention&#xD;
      http://www.stroke.org/sites/default/files/resources/tia-abcd2-tool.pdf?docID&#xD;
&#xD;
      There is also some correlation of clinical and biochemical predictors in subarachnoid,&#xD;
      cerebral venous thrombosis including Hunt and Hess, SAH score, WFNS-SAH grading among others&#xD;
      with variable predictive quality. (Rosen et al; Neurocritical Care; April 2005, Volume 2,&#xD;
      Issue 2, pp 110-118: Subarachnoid hemorrhage grading scales).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 6, 2017</start_date>
  <completion_date type="Actual">June 10, 2022</completion_date>
  <primary_completion_date type="Actual">June 10, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Improvement or worsening in stroke signs/symptoms.</measure>
    <time_frame>1 year</time_frame>
    <description>Prospective and retrospective analysis of patients with the acute brain injury, transient ischemic attack, acute and chronic ischemic and hemorrhagic stroke, subarachnoid hemorrhage, and cerebral venous thrombosis from pre-hospitalization, hospitalization (in-patient) and post hospitalization (clinic) data to determine factors which can predict stroke outcome.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">4594</enrollment>
  <condition>Stroke</condition>
  <condition>Acute Stroke</condition>
  <condition>Acute Brain Injury</condition>
  <condition>Ischemic Stroke</condition>
  <condition>Hemorrhagic Stroke</condition>
  <condition>Transient Ischemic Attack</condition>
  <condition>Subarachnoid Hemorrhage</condition>
  <condition>Cerebral Ischemia</condition>
  <condition>Cerebral Infarction</condition>
  <condition>Cerebral Stroke</condition>
  <condition>Venous Sinus Thrombosis, Cranial</condition>
  <arm_group>
    <arm_group_label>Patients with stroke</arm_group_label>
    <description>Patients with the Acute Brain injury, Transient Ischemic Attack, Acute and Chronic Ischemic and Hemorrhagic Stroke, Subarachnoid hemorrhage, and cerebral venous thrombosis from pre-hospitalization, hospitalization (in-patient) and post hospitalization (clinic) data</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients without stroke</arm_group_label>
    <description>Control subject who have the risk factors but never had stroke.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a final/discharge diagnosis of stroke or transient ischemic attack can be&#xD;
        included into the Stroke Registry. This includes cases with a principal/primary or&#xD;
        secondary diagnosis of:&#xD;
&#xD;
          -  Cerebral Infarction&#xD;
&#xD;
          -  Intracerebral Hemorrhage (non-traumatic)&#xD;
&#xD;
          -  Ischemic Stroke&#xD;
&#xD;
          -  Subarachnoid Hemorrhage (non-traumatic)&#xD;
&#xD;
          -  Transient Ischemic Attack (TIA)&#xD;
&#xD;
          -  Acute Brain Injury&#xD;
&#xD;
          -  Cerebral Venous Sinus Thrombosis&#xD;
&#xD;
        The investigators will use the available EMR and databases to search for these patients&#xD;
        using relevant ICD-9/10 codes.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All patients with a diagnosis of Acute Brain injury, Transient Ischemic Attack, Acute&#xD;
             and Chronic Ischemic and Hemorrhagic Stroke, Subarachnoid hemorrhage, and cerebral&#xD;
             venous thrombosis seen in UNMH.&#xD;
&#xD;
          2. Age &gt;1 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who don't have the diagnosis of Acute Brain injury, Transient Ischemic&#xD;
             Attack, Acute and Chronic Ischemic and Hemorrhagic Stroke, Subarachnoid hemorrhage,&#xD;
             and cerebral venous thrombosis.&#xD;
&#xD;
          2. Patients who have Epidural Hematoma, Subdural hematoma.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michel Torbey, MD, MPH</last_name>
    <role>Study Chair</role>
    <affiliation>University of New Mexico</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Atif Zafar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of New Mexico</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Asad Ikram, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of New Mexico</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mudassir Farooqui, MD, MPH</last_name>
    <role>Study Director</role>
    <affiliation>University of New Mexico</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Neurology, University of New Mexico</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131-0007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>August 19, 2022</last_update_submitted>
  <last_update_submitted_qc>August 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>identification</keyword>
  <keyword>diagnosis</keyword>
  <keyword>management</keyword>
  <keyword>investigation</keyword>
  <keyword>prevalence</keyword>
  <keyword>incidence</keyword>
  <keyword>quality of care</keyword>
  <keyword>hospitalization</keyword>
  <keyword>morbidity</keyword>
  <keyword>disability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Subarachnoid Hemorrhage</mesh_term>
    <mesh_term>Ischemic Attack, Transient</mesh_term>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Cerebrovascular Disorders</mesh_term>
    <mesh_term>Brain Ischemia</mesh_term>
    <mesh_term>Hemorrhagic Stroke</mesh_term>
    <mesh_term>Sinus Thrombosis, Intracranial</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Ischemia</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03281590
org study id: 17-281
nct id: NCT03281590
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a single institutional registry database for the patients with stroke and
      cerebrovascular diseases. Stroke is the fifth leading cause of death in the United States.
      Despite extensive research, most of the patients die or suffer from varying degree of
      post-stroke disabilities due to neurologic deficits. This registry aims to understand the
      disease and examine the disease dynamics in the local community.
Stroke is the fifth cause of all-cause mortality in US http://www.cdc.gov/stroke/facts.htm
      Early identification and treatment not only prevent mortality but also morbidity. Recent
      advancement in the imaging and diagnostic technique and novel therapeutic modalities has
      dramatically helped to downgrade stroke from the list of top mortality index in the last 3
      years. However, studies determining factors which help predict stroke outcome are still
      underway and much work needs to be done in this direction. Many factors currently are used to
      predict stroke outcome with varying results, for e.g. NIHSS is a good predictor of stroke
      outcome at 3 months; however, the investigators need better predictors, outcome scales or
      outcome measures which are easy, reliable and has better specificity and sensitivity.

      Acute Brain injury, Transient Ischemic Attack is a special category of a neurological
      condition wherein there is an impending devastating outcome if workup is not completed in a
      timely fashion. There is an urgent need to do investigations with high-risk patients to
      prevent stroke and further mortality and morbidity. The abcd2 score can help us to risk
      stratify the TIA and to predict the chances of stroke in this specific cohort. However,
      investigators need better identifiers than already present, to improve the patient changes in
      secondary prophylaxis of stroke prevention
      http://www.stroke.org/sites/default/files/resources/tia-abcd2-tool.pdf?docID

      There is also some correlation of clinical and biochemical predictors in subarachnoid,
      cerebral venous thrombosis including Hunt and Hess, SAH score, WFNS-SAH grading among others
      with variable predictive quality. (Rosen et al; Neurocritical Care; April 2005, Volume 2,
      Issue 2, pp 110-118: Subarachnoid hemorrhage grading scales).
observational model: Other
time perspective: Other
measure: Improvement or worsening in stroke signs/symptoms.
time frame: 1 year
description: Prospective and retrospective analysis of patients with the acute brain injury, transient ischemic attack, acute and chronic ischemic and hemorrhagic stroke, subarachnoid hemorrhage, and cerebral venous thrombosis from pre-hospitalization, hospitalization (in-patient) and post hospitalization (clinic) data to determine factors which can predict stroke outcome.
arm group label: Patients with stroke
description: Patients with the Acute Brain injury, Transient Ischemic Attack, Acute and Chronic Ischemic and Hemorrhagic Stroke, Subarachnoid hemorrhage, and cerebral venous thrombosis from pre-hospitalization, hospitalization (in-patient) and post hospitalization (clinic) data
arm group label: Patients without stroke
description: Control subject who have the risk factors but never had stroke.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michel Torbey, MD, MPH
role: Study Chair
affiliation: University of New Mexico
last name: Atif Zafar, MD
role: Principal Investigator
affiliation: University of New Mexico
last name: Asad Ikram, MD
role: Study Director
affiliation: University of New Mexico
last name: Mudassir Farooqui, MD, MPH
role: Study Director
affiliation: University of New Mexico
facility: 
country: United States
responsible party type: Sponsor
mesh term: Stroke
mesh term: Brain Injuries
mesh term: Ischemic Stroke
mesh term: Subarachnoid Hemorrhage
mesh term: Ischemic Attack, Transient
mesh term: Cerebral Infarction
mesh term: Cerebrovascular Disorders
mesh term: Brain Ischemia
mesh term: Hemorrhagic Stroke
mesh term: Sinus Thrombosis, Intracranial
mesh term: Thrombosis
mesh term: Ischemia
mesh term: Hemorrhage
sharing ipd: No