Clinical Trial: CoHOrt of Cerebral CavernOus maLformATion: multicEnter Prospective Observational Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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 Summary:

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.


Sponsor: Seoul National University Hospital

Current Primary Outcome: Symptomatic hemorrhage [ Time Frame: 5 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Symptomatic hemorrhage [ Time Frame: 1 year ]
  • All hemorrhagic event including radiologic rupture + newly appeared neurologic symptom [ Time Frame: 1 year ]
  • All hemorrhagic event including radiologic rupture [ Time Frame: 5 year ]


Original Secondary Outcome: Same as current

Information By: Seoul National University Hospital

Dates:
Date Received: October 26, 2016
Date Started: June 2016
Date Completion: December 2022
Last Updated: January 14, 2017
Last Verified: January 2017