Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
Study NCT ID:
NCT02946866
Status:
UNKNOWN
Last Update Posted:
2022-05-12
First Post:
2016-10-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CoHOrt of Cerebral CavernOus maLformATion: multicEnter Prospective Observational Study
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
A Prospective Study for the Natural History and the Risk Factors of Prospective Symptomatic Hemorrhage in Adult Patients With Cerebral Cavernous Malformation
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHOCOOATE
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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: