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

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ClinicalTrials.gov Identifier: NCT02553109
Recruitment Status : Active, not recruiting
First Posted : September 17, 2015
Last Update Posted : September 20, 2019
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Jeong Eun Kim, Seoul National University Hospital

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.

Condition or disease
Unruptured Aneurysm of Carotid Artery

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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 682 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: The Risk of Rupture or Growth in Patients With Small Unruptured Paraclinoid Aneurysm: Paraclinoid ANeurysm Prospectively Driven ObseRvational Analysis (PANDORA) Study
Study Start Date : January 2015
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

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.



Primary Outcome Measures :
  1. 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.

  2. Number of rupture of enrolled paraclinoid aneurysms [ Time Frame: within 5years after enrollment ]

Secondary Outcome Measures :
  1. Mortality rate of enrolled patients(related to rupture of aneurysm or not) [ Time Frame: within 5years after enrollment ]
  2. Number of participants with worsened modified Rankin scale score [ Time Frame: within 5years after enrollment ]
    from 0(No symptom at all) to 6(Dead)

  3. Number of participants with worsened Karnofsky Performance Status scale [ Time Frame: within 5years after enrollment ]
    from 0(Dead) to 100(Normal)

  4. Treatment(due to growth or rupture) rate of enrolled aneurysms [ Time Frame: within 5years after enrollment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02553109


Locations
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Korea, Republic of
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, Korea, Republic of
Sungkyunkwan University Samsung Medical center
Seoul, Kangnam, Korea, Republic of, 06351
HUMC-Chuncheon Sacred Heart Hospital
Chuncheon, Kangwon, Korea, Republic of
KangWon National University Hospital
Chuncheon, Kangwon, Korea, Republic of
DongGuk University
Ilsan, Kyungkido, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Kyungkido, Korea, Republic of, 13620
Jeju National University Hospital
Jeju, Korea, Republic of
Asan Medical center
Seoul, Korea, Republic of, 05505
Seoul National University Hospital
Seoul, Korea, Republic of
SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of
Soonchunhyang University Hospital - Seoul
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
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
Investigators
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Principal Investigator: Jeong Eun Kim, MD. PhD. Seoul National University Hospital

Additional Information:

Publications:

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Responsible Party: Jeong Eun Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02553109     History of Changes
Other Study ID Numbers: SNUH-001
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jeong Eun Kim, Seoul National University Hospital:
small paraclinoid
Additional relevant MeSH terms:
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Aneurysm
Vascular Diseases
Cardiovascular Diseases