CoHOrt of Cerebral CavernOus maLformATion: multicEnter Prospective Observational Study

Brief Title

CoHOrt of Cerebral CavernOus maLformATion: multicEnter Prospective Observational Study

Official Title

A Prospective Study for the Natural History and the Risk Factors of Prospective Symptomatic Hemorrhage in Adult Patients With Cerebral Cavernous Malformation

Brief Summary

      The aim of this prospective study is to reveal the natural history of symptomatic hemorrhage
      in adult patients with cerebral cavernous malformation with the goal of informing the
      treatment plan.
    

Detailed Description

      Cerebral cavernous malformation Patients with newly diagnosed, cerebral cavernous
      malformation who will visit one of the study centers during the period from June 2016 to
      December 2017. Patients would be eligible for enrollment if they were 18 years of age or
      older and had at least 1 cerebral cavernous malformation. If the patient had multiple
      cavernous malformations, index cavernous malformation would be enrolled. Index lesion will be
      determined according to the criteria.

        -  Index lesion decision criteria I. Symptomatic II. Asymptomatic (priorities are as
           follows)

             1. Previous bleed

             2. Brain stem location

             3. Deep nuclei (thalamus, caudate, basal ggl, hypothalamus)

             4. Periventricular

             5. Largest

      All patients who would visit a study center during the enrollment period and meet these
      criteria will be asked to join the study. The cohort will consists of patients who agree to
      participate. Target population of this study is 228 patients.
    


Study Type

Observational


Primary Outcome

Symptomatic hemorrhage

Secondary Outcome

 Symptomatic hemorrhage

Condition

Cerebral Cavernous Malformation


Study Arms / Comparison Groups

 Cerebral cavernous malformation
Description:  Patients with newly diagnosed, cerebral cavernous malformation who will visit one of the study centers during the period from June 2016 to December 2017. Patients would be eligible for enrollment if they were 18 years of age or older and had at least 1 cavernous malformation. All patients who would visit a study center during the enrollment period and meet these criteria will be asked to join the study. The cohort will consists of patients who agree to participate. Target population of this study is 228 patients.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

228

Start Date

June 2016

Completion Date

December 2025

Primary Completion Date

December 2025

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with newly diagnosed cerebral cavernous malformation who agreed to
             participate.

          -  18 years old or more

        Exclusion Criteria:

          -  Patients who underwent treatment(surgery or radiosurgery) for cavernous malformation

          -  Patients who are accompanied by other serious medical problems
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

JeongEun Kim, MD. PhD., 82-2-2072-2358, [email protected]

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT02946866

Organization ID

SNUH-002


Responsible Party

Principal Investigator

Study Sponsor

Seoul National University Hospital

Collaborators

 Asan Medical Center

Study Sponsor

JeongEun Kim, MD. PhD., Principal Investigator, Study Principal Investigator


Verification Date

September 2019