CoHOrt of Cerebral CavernOus maLformATion: multicEnter Prospective Observational Study (CHOCOOATE)

Seoul National University

Status: Active, not recruiting

Conditions: Cerebral Cavernous Malformation; Intracerebral Hemorrhage

Study type: Observational

Funder types: Other

Identifiers

NCT02946866

SNUH-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 228 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

228 participants in 1 patient group

Cerebral cavernous malformation

Description:

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.