Clinical trial NCT02553109: Paraclinoid ANeurysm Prospectively Driven ObseRvational Analysis (PANDORA) Study
Official title: The Risk of Rupture or Growth in Patients With Small Unruptured Paraclinoid Aneurysm: Paraclinoid ANeurysm Prospectively Driven ObseRvational Analysis (PANDORA) Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Unruptured Aneurysm of Carotid Artery
Keywords: small paraclinoid
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
name: SMG-SNU Boramae Medical Center
name: DongGuk University
name: Inje University
name: Jeju National University Hospital
name: KangWon National University Hospital
name: Gyeongsang National University Hospital
name: Soonchunhyang University Hospital
name: Samsung Medical Center
name: Asan Medical Center
First posted: 2015-09-17
Enrollment: 682
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed small unruptured paraclinoid aneurysms who agreed to participate.
* 20years old or more
* less than 5mm in maximum diameter
* neurological status of patients should be satisfied with less than modified Rankin score 2 or more than 70 in Karnofsky performance score

Exclusion Criteria:

* patients had previous subarachnoid hemorrhage that could be related to the rupture of paraclinoid aneurysm.
* traumatic, infectious or dissecting aneurysms
* fusiform aneurysms
* aneurysms that related to other vascular disease or brain tumor
* aneurysm that associated with the atherosclerotic change of a parent artery

Primary outcomes:
measure: Number of increased maximal diameter of enrolled paraclinoid aneurysms on follow up MRA or CTA
timeFrame: within 5years after enrollment
measure: Number of rupture of enrolled paraclinoid aneurysms
timeFrame: within 5years after enrollment
Secondary outcomes:
measure: Mortality rate of enrolled patients(related to rupture of aneurysm or not)
timeFrame: within 5years after enrollment
measure: Number of participants with worsened modified Rankin scale score
timeFrame: within 5years after enrollment
measure: Number of participants with worsened Karnofsky Performance Status scale
timeFrame: within 5years after enrollment
measure: Treatment(due to growth or rupture) rate of enrolled aneurysms
timeFrame: within 5years after enrollment
Other outcomes:
Locations:
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
state: Gyeongsangnam-do
city: Seoul
country: Korea, Republic of
facility: Sungkyunkwan University Samsung Medical center
state: Kangnam
city: Chuncheon
country: Korea, Republic of
facility: KangWon National University Hospital
state: Kangwon
city: Ilsan
country: Korea, Republic of
facility: DongGuk University
state: Kyungkido
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyungkido
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital - Seoul
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Eun Kim, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.