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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02946866
Acronym
CHOCOOATE
Enrollment
228
Registered
2016-10-27
Start date
2016-06-30
Completion date
2024-12-31
Last updated
2022-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Cavernous Malformation, Intracerebral Hemorrhage

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.

Interventions

None listed

Sponsors

Asan Medical Center
CollaboratorOTHER
KangWon National University Hospital
CollaboratorOTHER
Jeju National University Hospital
CollaboratorOTHER
Chuncheon Sacred Heart Hospital
CollaboratorOTHER
SMG-SNU Boramae Medical Center
CollaboratorOTHER
Gyeongsang National University Hospital
CollaboratorOTHER
Soonchunhyang University Hospital
CollaboratorOTHER
Johannes Gutenberg University Mainz
CollaboratorOTHER
First Affiliated Hospital of Suzhou Medical College
CollaboratorOTHER
Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Symptomatic hemorrhage5 yearhemorrhage due to rupture of cavernous malformation

Secondary

MeasureTime frameDescription
Symptomatic hemorrhage1 yearhemorrhage due to rupture of cavernous malformation
All hemorrhagic event including radiologic rupture + newly appeared neurologic symptom1 yearhemorrhage without symptom
All hemorrhagic event including radiologic rupture5 yearall hemorrhagic events

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026