Unruptured Aneurysm of Carotid Artery
Conditions
Keywords
small paraclinoid
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.
Interventions
None listed
Sponsors
Seoul National University Bundang Hospital
SMG-SNU Boramae Medical Center
DongGuk University
Inje University
Jeju National University Hospital
KangWon National University Hospital
Gyeongsang National University Hospital
Soonchunhyang University Hospital
Samsung Medical Center
Asan Medical Center
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of increased maximal diameter of enrolled paraclinoid aneurysms on follow up MRA or CTA | within 5years after enrollment | 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. |
| Number of rupture of enrolled paraclinoid aneurysms | within 5years after enrollment | annual rupture rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality rate of enrolled patients(related to rupture of aneurysm or not) | within 5years after enrollment | death due to ruptured aneurysm |
| Number of participants with worsened modified Rankin scale score | within 5years after enrollment | from 0(No symptom at all) to 6(Dead) |
| Number of participants with worsened Karnofsky Performance Status scale | within 5years after enrollment | from 0(Dead) to 100(Normal) |
| Treatment(due to growth or rupture) rate of enrolled aneurysms | within 5years after enrollment | — |
Countries
South Korea
Outcome results
None listed