CClinicalTrials.gg
Status unknownNCT02946866CHOCOOATEUpdated May 12, 2022

CoHOrt of Cerebral CavernOus maLformATion: multicEnter Prospective Observational Study

An observational study in Cerebral Cavernous Malformation and Intracerebral Hemorrhage, sponsored by Seoul National University Hospital. Status unknown at 8 sites in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-05-12.

Sponsored by Seoul National University Hospital · Observational

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
228
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cerebral Cavernous Malformation
  • Intracerebral Hemorrhage
03

In context

Cerebral Hemorrhage

476 studies on the registry are indexed under Cerebral Hemorrhage; 181 are open to participants now.

This study's enrollment of 228 is below the median of 275 across 180 observational studies indexed under Cerebral Hemorrhage.

Browse Cerebral Hemorrhage studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Investigators defined the cohort population as adults( more than 18 years old) with newly diagnosed cerebral cavernous malformation who agree to participate.

Inclusion criteria

  • Patients with newly diagnosed cerebral cavernous malformation who agreed to participate.
  • 18 years old or more

Exclusion criteria

Exclusion Criteria:

  • Patients who underwent treatment(surgery or radiosurgery) for cavernous malformation
  • Patients who are accompanied by other serious medical problems
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
228 participants (actual)
Patient registry
No

Groups and cohorts

  • 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 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.

06

What researchers measure

Primary outcomes

  1. Symptomatic hemorrhage

    hemorrhage due to rupture of cavernous malformation

    Time frame: 5 year

Secondary outcomes

  1. Symptomatic hemorrhage

    hemorrhage due to rupture of cavernous malformation

    Time frame: 1 year

  2. All hemorrhagic event including radiologic rupture + newly appeared neurologic symptom

    hemorrhage without symptom

    Time frame: 1 year

  3. All hemorrhagic event including radiologic rupture

    all hemorrhagic events

    Time frame: 5 year

07

Study locations

8 sites
  • KangWon National University Hospital
    Chuncheon, Kangwon, Korea, Republic of
  • HUMC-Chuncheon Sacred Heart Hospital
    Chuncheon, Kanwon, Korea, Republic of
  • DongGuk University
    Ilsan, Kyungkido, Korea, Republic of
  • Gyeongsang National University Hospital
    Jinju, South Gyeongsang 52727, Korea, Republic of
  • Jeju National University Hospital
    Jeju, Korea, Republic of
  • Soonchunhyang University Hospital Seoul
    Seoul, 04401, Korea, Republic of
  • Asan Medical center
    Seoul, Korea, Republic of
  • Seoul National University Hospital
    Seoul, Korea, Republic of
08

References and documents

Publications

  • Jeon JS, Kim JE, Chung YS, Oh S, Ahn JH, Cho WS, Son YJ, Bang JS, Kang HS, Sohn CH, Oh CW. A risk factor analysis of prospective symptomatic haemorrhage in adult patients with cerebral cavernous malformation. J Neurol Neurosurg Psychiatry. 2014 Dec;85(12):1366-70. doi: 10.1136/jnnp-2013-306844. Epub 2014 Mar 28. PubMed 24681702 ↗
  • Horne MA, Flemming KD, Su IC, Stapf C, Jeon JP, Li D, Maxwell SS, White P, Christianson TJ, Agid R, Cho WS, Oh CW, Wu Z, Zhang JT, Kim JE, Ter Brugge K, Willinsky R, Brown RD Jr, Murray GD, Al-Shahi Salman R; Cerebral Cavernous Malformations Individual Patient Data Meta-analysis Collaborators. Clinical course of untreated cerebral cavernous malformations: a meta-analysis of individual patient data. Lancet Neurol. 2016 Feb;15(2):166-173. doi: 10.1016/S1474-4422(15)00303-8. Epub 2015 Dec 2. PubMed 26654287 ↗
  • Al-Shahi Salman R, Berg MJ, Morrison L, Awad IA; Angioma Alliance Scientific Advisory Board. Hemorrhage from cavernous malformations of the brain: definition and reporting standards. Angioma Alliance Scientific Advisory Board. Stroke. 2008 Dec;39(12):3222-30. doi: 10.1161/STROKEAHA.108.515544. Epub 2008 Oct 30. PubMed 18974380 ↗
  • Porter PJ, Willinsky RA, Harper W, Wallace MC. Cerebral cavernous malformations: natural history and prognosis after clinical deterioration with or without hemorrhage. J Neurosurg. 1997 Aug;87(2):190-7. doi: 10.3171/jns.1997.87.2.0190. PubMed 9254081 ↗
  • Flemming KD, Link MJ, Christianson TJ, Brown RD Jr. Prospective hemorrhage risk of intracerebral cavernous malformations. Neurology. 2012 Feb 28;78(9):632-6. doi: 10.1212/WNL.0b013e318248de9b. Epub 2012 Feb 1. PubMed 22302553 ↗
  • Schneble HM, Soumare A, Herve D, Bresson D, Guichard JP, Riant F, Tournier-Lasserve E, Tzourio C, Chabriat H, Stapf C. Antithrombotic therapy and bleeding risk in a prospective cohort study of patients with cerebral cavernous malformations. Stroke. 2012 Dec;43(12):3196-9. doi: 10.1161/STROKEAHA.112.668533. Epub 2012 Nov 13. PubMed 23150651 ↗
  • Al-Shahi Salman R, Hall JM, Horne MA, Moultrie F, Josephson CB, Bhattacharya JJ, Counsell CE, Murray GD, Papanastassiou V, Ritchie V, Roberts RC, Sellar RJ, Warlow CP; Scottish Audit of Intracranial Vascular Malformations (SAIVMs) collaborators. Untreated clinical course of cerebral cavernous malformations: a prospective, population-based cohort study. Lancet Neurol. 2012 Mar;11(3):217-24. doi: 10.1016/S1474-4422(12)70004-2. Epub 2012 Jan 31. PubMed 22297119 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02946866
Lead sponsor
Seoul National University Hospital
Collaborators
Asan Medical Center, KangWon National University Hospital, Jeju National University Hospital, Chuncheon Sacred Heart Hospital, SMG-SNU Boramae Medical Center, Gyeongsang National University Hospital, Soonchunhyang University Hospital, Johannes Gutenberg University Mainz, First Affiliated Hospital of Suzhou Medical College
Responsible party
Jeong Eun Kim (Professor, Seoul National University Hospital) — Principal investigator
First posted
Oct 27, 2016
Start date
Jun 2016
Primary completion
Dec 2023 (estimated)
Completion
Dec 2024 (estimated)
Last update
May 12, 2022

Study contacts

JeongEun Kim, MD. PhD.
principal investigator · Study Principal Investigator

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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