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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02946866
Other study ID # SNUH-002
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 2016
Est. completion date December 2024

Study information

Verified date May 2022
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 228
Est. completion date December 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Locations

Country Name City State
Korea, Republic of HUMC-Chuncheon Sacred Heart Hospital Chuncheon Kanwon
Korea, Republic of KangWon National University Hospital Chuncheon Kangwon
Korea, Republic of DongGuk University Ilsan Kyungkido
Korea, Republic of Jeju National University Hospital Jeju
Korea, Republic of Gyeongsang National University Hospital Jinju South Gyeongsang
Korea, Republic of Asan Medical center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Soonchunhyang University Hospital Seoul Seoul

Sponsors (10)

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

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Schneble HM, Soumare A, Hervé 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Symptomatic hemorrhage hemorrhage due to rupture of cavernous malformation 5 year
Secondary Symptomatic hemorrhage hemorrhage due to rupture of cavernous malformation 1 year
Secondary All hemorrhagic event including radiologic rupture + newly appeared neurologic symptom hemorrhage without symptom 1 year
Secondary All hemorrhagic event including radiologic rupture all hemorrhagic events 5 year
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