Paraclinoid ANeurysm Prospectively Driven ObseRvational Analysis (PANDORA) Study (PANDORA)

May 9, 2022 updated by: Jeong Eun Kim, Seoul National University Hospital

The Risk of Rupture or Growth in Patients With Small Unruptured Paraclinoid Aneurysm: Paraclinoid ANeurysm Prospectively Driven ObseRvational Analysis (PANDORA) Study

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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Actual)

682

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • SMG-SNU Boramae Medical Center
      • Seoul, Korea, Republic of
        • Soonchunhyang University Hospital - Seoul
    • Gyeongsangnam-do
      • Jinju, Gyeongsangnam-do, Korea, Republic of
        • Gyeongsang National University Hospital
    • Kangnam
      • Seoul, Kangnam, Korea, Republic of, 06351
        • Sungkyunkwan University Samsung Medical Center
    • Kangwon
      • Chuncheon, Kangwon, Korea, Republic of
        • Kangwon National University Hospital
    • Kyungkido
      • Ilsan, Kyungkido, Korea, Republic of
        • DongGuk University
      • Seongnam-si, Kyungkido, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of increased maximal diameter of enrolled paraclinoid aneurysms on follow up MRA or CTA
Time Frame: 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.
within 5years after enrollment
Number of rupture of enrolled paraclinoid aneurysms
Time Frame: within 5years after enrollment
annual rupture rate
within 5years after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate of enrolled patients(related to rupture of aneurysm or not)
Time Frame: within 5years after enrollment
death due to ruptured aneurysm
within 5years after enrollment
Number of participants with worsened modified Rankin scale score
Time Frame: within 5years after enrollment
from 0(No symptom at all) to 6(Dead)
within 5years after enrollment
Number of participants with worsened Karnofsky Performance Status scale
Time Frame: within 5years after enrollment
from 0(Dead) to 100(Normal)
within 5years after enrollment
Treatment(due to growth or rupture) rate of enrolled aneurysms
Time Frame: within 5years after enrollment
within 5years after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Samsung Medical Center
Asan Medical Center
Seoul National University Bundang Hospital
Inje University
Gyeongsang National University Hospital
SMG-SNU Boramae Medical Center
Soonchunhyang University Hospital
Jeju National University Hospital
DongGuk University
KangWon National University Hospital

Investigators

  • Principal Investigator: Jeong Eun Kim, MD. PhD., Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

August 20, 2015

First Submitted That Met QC Criteria

September 16, 2015

First Posted (Estimate)

September 17, 2015

Study Record Updates

Last Update Posted (Actual)

May 12, 2022

Last Update Submitted That Met QC Criteria

May 9, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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