CoHOrt of Cerebral CavernOus maLformATion: multicEnter Prospective Observational Study

Study Overview
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Brief Summary
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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
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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) Previous bleed Brain stem location Deep nuclei (thalamus, caudate, basal ggl, hypothalamus) Periventricular 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.

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

Conditions
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Cerebral Cavernous Malformation, Intracerebral Hemorrhage

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cerebral cavernous malformation<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic hemorrhage | hemorrhage due to rupture of cavernous malformation | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic hemorrhage | hemorrhage due to rupture of cavernous malformation | 1 year | 
| All hemorrhagic event including radiologic rupture + newly appeared neurologic symptom | hemorrhage without symptom | 1 year | 
| All hemorrhagic event including radiologic rupture | all hemorrhagic events | 5 year |