NCT02946866

CoHOrt of Cerebral CavernOus maLformATion: multicEnter Prospective Observational Study

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 228 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Cavernous Malformation
• Intracerebral Hemorrhage

Timeline

• Start date: 2016-06-01
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2016-10-27
• Last updated: 2022-05-12

Locations

8 sites across 1 country: South Korea