CoHOrt of Cerebral CavernOus maLformATion: multicEnter Prospective Observational Study

Intracerebral Hemorrhage Clinical Trial

— CHOCOOATE  

Official title:

A Prospective Study for the Natural History and the Risk Factors of Prospective Symptomatic Hemorrhage in Adult Patients With Cerebral Cavernous Malformation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02946866
• Other study ID #: SNUH-002
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cerebral Cavernous Malformation
• Cerebral Hemorrhage
• Congenital Abnormalities
• Hemorrhage
• Intracerebral Hemorrhage

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