CoHOrt of Cerebral CavernOus maLformATion: multicEnter Prospective Observational Study

Active, not recruiting

• Conditions: Cerebral Cavernous Malformation; Intracerebral Hemorrhage

• Registration Number: NCT02946866
• Lead Sponsor: Seoul National University Hospital

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 Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-10-26
• Study First Submitted QC: 2016-10-26
• Study First Posted: 2016-10-27
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-09
• Last Update Posted: 2022-05-12
• Primary Completion: 2023-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 228

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptomatic hemorrhage	5 year	hemorrhage due to rupture of cavernous malformation

Secondary Outcome Measures

Name	Time	Method
All hemorrhagic event including radiologic rupture	5 year	all hemorrhagic events
Symptomatic hemorrhage	1 year	hemorrhage due to rupture of cavernous malformation
All hemorrhagic event including radiologic rupture + newly appeared neurologic symptom	1 year	hemorrhage without symptom

Trial Locations

Locations (8)

DongGuk University; 🇰🇷 Ilsan, Kyungkido, Korea, Republic of

Gyeongsang National University Hospital; 🇰🇷 Jinju, South Gyeongsang, Korea, Republic of

Asan Medical center; 🇰🇷 Seoul, Korea, Republic of

HUMC-Chuncheon Sacred Heart Hospital; 🇰🇷 Chuncheon, Kanwon, Korea, Republic of

KangWon National University Hospital; 🇰🇷 Chuncheon, Kangwon, Korea, Republic of

Soonchunhyang University Hospital Seoul; 🇰🇷 Seoul, Korea, Republic of

Jeju National University Hospital; 🇰🇷 Jeju, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of