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| Name | Class |
|---|---|
| Seoul National University Bundang Hospital | OTHER |
| SMG-SNU Boramae Medical Center | OTHER |
| DongGuk University | OTHER |
| Inje University |
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The optimal consensus concerning treatment of incidental small paraclinoid unruptured intracranial aneurysms (UIAs) remains controversial. The aim of this prospective study is to reveal the natural history of small paraclinoid UIAs with the goal of informing the treatment plan.
A prospective observational study will be conducted in 13 Korean centers enrolling a consecutive series of 645 patients with small paraclinoid unruptured intracranial aneurysms (UIAs) from 2015 to 2017.
The investigators defined the cohort population as adults(20 years old or more) with small (less than 5mm) unruptured paraclinoid aneurysm. To determine the growth rate and risk factors, the angiographic features based on MRA or CTA(ex) size, arterial relationship, multiplicity)and the clinical characteristics (ex) age, hypertension (HTN), diabetes mellitus(DM), Hyperlipidemia, smoking) are recorded at initial visit, 1 year, 2years, 3years, and 5years.
The cumulative risk and the risk factors of aneurysmal rupture and growth will be analysed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| small unruptured paraclinoid aneurysm | Patients with newly diagnosed, small (less than 5mm) unruptured paraclinoid aneurysms who will visit one of the study centers during the period from January 2015 to February 2017. Patients would be eligible for enrollment if they were 20 years of age or older and had an unruptured paraclinoid aneurysm that is less than 5 mm in the largest dimension. 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 645 aneurysms. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of increased maximal diameter of enrolled paraclinoid aneurysms on follow up MRA or CTA | If, the maximal diameter(in mm) of aneurysm which is measured by 1 neurosurgeon and 1 neuroradiologist on follow up MRA or CTA (1,2,3,5 year follow up) is 1.5 times bigger than on initial MRA or CTA, investigators will decide that the aneurysm is increased. | within 5years after enrollment |
| Number of rupture of enrolled paraclinoid aneurysms | annual rupture rate | within 5years after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate of enrolled patients(related to rupture of aneurysm or not) | death due to ruptured aneurysm | within 5years after enrollment |
| Number of participants with worsened modified Rankin scale score |
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Inclusion Criteria:
Exclusion Criteria:
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Invastigators defined the cohort population as adults( more than 20 years old) with newly diagnosed small (less than 5mm) unruptured paraclinoid aneurysm who agree to participate.
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| Name | Affiliation | Role |
|---|---|---|
| Jeong Eun Kim, MD. PhD. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KangWon National University Hospital | Chuncheon | Gangwon-do | South Korea | |||
| Gyeongsang National University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23781005 | Background | Jeon JS, Ahn JH, Huh W, Son YJ, Bang JS, Kang HS, Sohn CH, Oh CW, Kwon OK, Kim JE. A retrospective analysis on the natural history of incidental small paraclinoid unruptured aneurysm. J Neurol Neurosurg Psychiatry. 2014 Mar;85(3):289-94. doi: 10.1136/jnnp-2013-305019. Epub 2013 Jun 18. | |
| 15912157 | Background |
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| OTHER |
| Jeju National University Hospital | OTHER |
| KangWon National University Hospital | OTHER |
| Gyeongsang National University Hospital | OTHER |
| Soonchunhyang University Hospital | OTHER |
| Samsung Medical Center | OTHER |
| Asan Medical Center | OTHER |
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from 0(No symptom at all) to 6(Dead)
| within 5years after enrollment |
| Number of participants with worsened Karnofsky Performance Status scale | from 0(Dead) to 100(Normal) | within 5years after enrollment |
| Treatment(due to growth or rupture) rate of enrolled aneurysms | within 5years after enrollment |
| Jinju |
| Gyeongsangnam-do |
| South Korea |
| Sungkyunkwan University Samsung Medical center | Seoul | Kangnam | 06351 | South Korea |
| DongGuk University | Ilsan | Kyungkido | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Kyungkido | 13620 | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| SMG-SNU Boramae Medical Center | Seoul | South Korea |
| Soonchunhyang University Hospital - Seoul | Seoul | South Korea |
| Barami K, Hernandez VS, Diaz FG, Guthikonda M. Paraclinoid Carotid Aneurysms: Surgical Management, Complications, and Outcome Based on a New Classification Scheme. Skull Base. 2003 Feb;13(1):31-41. doi: 10.1055/s-2003-820555. |
| 23868274 | Background | Juvela S, Poussa K, Lehto H, Porras M. Natural history of unruptured intracranial aneurysms: a long-term follow-up study. Stroke. 2013 Sep;44(9):2414-21. doi: 10.1161/STROKEAHA.113.001838. Epub 2013 Jul 18. |
| 20671254 | Background | Sonobe M, Yamazaki T, Yonekura M, Kikuchi H. Small unruptured intracranial aneurysm verification study: SUAVe study, Japan. Stroke. 2010 Sep;41(9):1969-77. doi: 10.1161/STROKEAHA.110.585059. Epub 2010 Jul 29. |
| 22738097 | Background | UCAS Japan Investigators; Morita A, Kirino T, Hashi K, Aoki N, Fukuhara S, Hashimoto N, Nakayama T, Sakai M, Teramoto A, Tominari S, Yoshimoto T. The natural course of unruptured cerebral aneurysms in a Japanese cohort. N Engl J Med. 2012 Jun 28;366(26):2474-82. doi: 10.1056/NEJMoa1113260. |
| 12867109 | Background | Wiebers DO, Whisnant JP, Huston J 3rd, Meissner I, Brown RD Jr, Piepgras DG, Forbes GS, Thielen K, Nichols D, O'Fallon WM, Peacock J, Jaeger L, Kassell NF, Kongable-Beckman GL, Torner JC; International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms: natural history, clinical outcome, and risks of surgical and endovascular treatment. Lancet. 2003 Jul 12;362(9378):103-10. doi: 10.1016/s0140-6736(03)13860-3. |