CoHOrt of Cerebral CavernOus maLformATion: multicEnter Prospective Observational Study

NCT02946866 | Unknown DMC

• 1 other identifier: SNUH-002
• Study Type: observational
• Target: 228
• Locations: 1 country
• Sites: 8

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.

Conditions

Cerebral Cavernous Malformation; Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Symptomatic hemorrhage

  hemorrhage due to rupture of cavernous malformation

  5 year

Secondary Outcomes (3)

• Symptomatic hemorrhage

  1 year

• All hemorrhagic event including radiologic rupture + newly appeared neurologic symptom

  1 year

• All hemorrhagic event including radiologic rupture

  5 year

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with newly diagnosed cerebral cavernous malformation who agreed to participate.
• years old or more

You may not qualify if:

• Patients who underwent treatment(surgery or radiosurgery) for cavernous malformation
• Patients who are accompanied by other serious medical problems

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Asan Medical Center: collaborator
• KangWon National University Hospital: collaborator
• Jeju National University Hospital: collaborator
• Chuncheon Sacred Heart Hospital: collaborator
• SMG-SNU Boramae Medical Center: collaborator
• Gyeongsang National University Hospital: collaborator
• Soonchunhyang University Hospital: collaborator
• Johannes Gutenberg University Mainz: collaborator
• First Affiliated Hospital of Suzhou Medical College: collaborator

Study Sites (8)

KangWon National University Hospital

Chuncheon, Gangwon-do, South Korea

Location

Gyeongsang National University Hospital

Jinju, Gyeongsangnam-do, 52727, South Korea

Location

HUMC-Chuncheon Sacred Heart Hospital

Chuncheon, Kanwon, South Korea

Location

DongGuk University

Ilsan, Kyungkido, South Korea

Location

Jeju National University Hospital

Jeju City, South Korea

Location

Soonchunhyang University Hospital Seoul

Seoul, 04401, South Korea

Location

Asan Medical center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (7)

• 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.

  PMID: 24681702 BACKGROUND

• 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.

  PMID: 26654287 BACKGROUND

• 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.

  PMID: 18974380 BACKGROUND

• 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.

  PMID: 9254081 BACKGROUND

• 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.

  PMID: 22302553 BACKGROUND

• 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.

  PMID: 23150651 BACKGROUND

• 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.

  PMID: 22297119 BACKGROUND

MeSH Terms

Conditions

Hemangioma, Cavernous, Central Nervous System; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Hemangioma, Cavernous; Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms; Cavernous Sinus Syndromes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Vascular Malformations; Nervous System Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Hemostatic Disorders; Vascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Intracranial Hemorrhages; Cerebrovascular Disorders; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• JeongEun Kim, MD. PhD.

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: October 27, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: May 12, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (8)