- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02946866
CoHOrt of Cerebral CavernOus maLformATion: multicEnter Prospective Observational Study (CHOCOOATE)
A Prospective Study for the Natural History and the Risk Factors of Prospective Symptomatic Hemorrhage in Adult Patients With Cerebral Cavernous Malformation
Study Overview
Status
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)
- Previous bleed
- Brain stem location
- Deep nuclei (thalamus, caudate, basal ggl, hypothalamus)
- Periventricular
- 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Jeju, Korea, Republic of
- Jeju National University Hospital
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Seoul, Korea, Republic of
- Seoul National University Hospital
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Seoul, Korea, Republic of
- Asan Medical Center
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Seoul, Korea, Republic of, 04401
- Soonchunhyang University Hospital Seoul
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Kangwon
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Chuncheon, Kangwon, Korea, Republic of
- Kangwon National University Hospital
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Kanwon
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Chuncheon, Kanwon, Korea, Republic of
- HUMC-Chuncheon Sacred Heart Hospital
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Kyungkido
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Ilsan, Kyungkido, Korea, Republic of
- DongGuk University
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South Gyeongsang
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Jinju, South Gyeongsang, Korea, Republic of, 52727
- Gyeongsang National University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptomatic hemorrhage
Time Frame: 5 year
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hemorrhage due to rupture of cavernous malformation
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5 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptomatic hemorrhage
Time Frame: 1 year
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hemorrhage due to rupture of cavernous malformation
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1 year
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All hemorrhagic event including radiologic rupture + newly appeared neurologic symptom
Time Frame: 1 year
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hemorrhage without symptom
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1 year
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All hemorrhagic event including radiologic rupture
Time Frame: 5 year
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all hemorrhagic events
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5 year
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: JeongEun Kim, MD. PhD., Study Principal Investigator
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Cardiovascular Abnormalities
- Hemangioma
- Neoplasms, Vascular Tissue
- Nervous System Malformations
- Vascular Malformations
- Intracranial Hemorrhages
- Central Nervous System Vascular Malformations
- Hemangioma, Cavernous
- Hemorrhage
- Congenital Abnormalities
- Cerebral Hemorrhage
- Hemangioma, Cavernous, Central Nervous System
Other Study ID Numbers
- SNUH-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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