Clinical trial NCT02946866: CoHOrt of Cerebral CavernOus maLformATion: multicEnter Prospective Observational Study
Official title: A Prospective Study for the Natural History and the Risk Factors of Prospective Symptomatic Hemorrhage in Adult Patients With Cerebral Cavernous Malformation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Cavernous Malformation
Intracerebral Hemorrhage
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Asan Medical Center
name: KangWon National University Hospital
name: Jeju National University Hospital
name: Chuncheon Sacred Heart Hospital
name: SMG-SNU Boramae Medical Center
name: Gyeongsang National University Hospital
name: Soonchunhyang University Hospital
name: Johannes Gutenberg University Mainz
name: First Affiliated Hospital of Suzhou Medical College
First posted: 2016-10-27
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptomatic hemorrhage
timeFrame: 5 year
Secondary outcomes:
measure: Symptomatic hemorrhage
timeFrame: 1 year
measure: All hemorrhagic event including radiologic rupture + newly appeared neurologic symptom
timeFrame: 1 year
measure: All hemorrhagic event including radiologic rupture
timeFrame: 5 year
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: KangWon National University Hospital
state: Kangwon
city: Chuncheon
country: Korea, Republic of
facility: HUMC-Chuncheon Sacred Heart Hospital
state: Kanwon
city: Ilsan
country: Korea, Republic of
facility: DongGuk University
state: Kyungkido
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
state: South Gyeongsang
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital Seoul
city: Seoul
country: Korea, Republic of
facility: Asan Medical center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Study Principal Investigator
name: JeongEun Kim, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.