CoHOrt of Cerebral CavernOus maLformATion: multicEnter Prospective Observational Study
NCT ID: NCT02946866
Last Updated: 2022-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
228 participants
OBSERVATIONAL
2016-06-30
2024-12-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 18 years old or more
Exclusion Criteria
* Patients who are accompanied by other serious medical problems
18 Years
80 Years
ALL
No
Sponsors
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Asan Medical Center
OTHER
KangWon National University Hospital
OTHER
Jeju National University Hospital
OTHER
Chuncheon Sacred Heart Hospital
OTHER
SMG-SNU Boramae Medical Center
OTHER
Gyeongsang National University Hospital
OTHER
Soonchunhyang University Hospital
OTHER
Johannes Gutenberg University Mainz
OTHER
First Affiliated Hospital of Suzhou Medical College
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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Jeong Eun Kim
Professor
Principal Investigators
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JeongEun Kim, MD. PhD.
Role: PRINCIPAL_INVESTIGATOR
Study Principal Investigator
Locations
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KangWon National University Hospital
Chuncheon, Gangwon-do, South Korea
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, South Korea
HUMC-Chuncheon Sacred Heart Hospital
Chuncheon, Kanwon, South Korea
DongGuk University
Ilsan, Kyungkido, South Korea
Jeju National University Hospital
Jeju City, , South Korea
Soonchunhyang University Hospital Seoul
Seoul, , South Korea
Asan Medical center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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SNUH-002
Identifier Type: -
Identifier Source: org_study_id
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