Aneurysm Genetic Risk in Patients With QIB Changes
AnGen
1 other identifier
observational
120
1 country
1
Brief Summary
Intracranial aneurysm rupture is a leading cause of hemorrhagic strokes which carry high mortality and disability rates as well as high healthcare costs. Unruptured intracranial aneurysms (UIA) are common in the general population, occurring in 1-2% of individuals. Previous studies have shown that UIA growth and rupture are strongly associated with each other, with growing aneurysms 9-12 times more likely to rupture, and nearly all aneurysms growing prior to rupture. Thanks to advanced medical imaging, UIA are now more and more often detected incidentally. However not all aneurysms qualify for preventive surgical or interventional procedures according to current International Study of Unruptured Intracranial Aneurysms (ISUIA) guidelines, and some must therefore be monitored for growth. Current guidelines are based heavily on size, an inconsistent predictor of future growth. To improve management strategies for individual patients and more comprehensively assess aneurysm risk, the investigators propose to identify risk factors related to growth. Aneurysm etiology is multifactorial, with both genetic and environmental contributions to aneurysm formation, growth, and rupture. Exploring new risk factors based on aneurysm natural history and understanding the mechanisms underlying aneurysm rupture have been extensive research areas. As previous studies have shown that quantitative imaging biomarkers (QIB) can provide a more accurate assessment of the characteristics of aneurysms, the investigators propose a combined study which identifies QIB associated with aneurysm growth to identify factors related to growth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 12, 2018
CompletedFirst Submitted
Initial submission to the registry
December 14, 2021
CompletedFirst Posted
Study publicly available on registry
April 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2023
CompletedMay 8, 2023
May 1, 2023
4.8 years
December 14, 2021
May 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quantitative imaging biomarkers (QIB) change
Number of participants with changes in quantitative imaging biomarkers
3 years
Secondary Outcomes (1)
Genetic biomarkers in QIB change
3 years
Eligibility Criteria
UCLA patients who come for yearly CT or MR angiography for cerebral aneurysm surveillance.
You may qualify if:
- Patients with unruptured cerebral aneurysms followed yearly using non-invasive imaging techniques including Computed tomography (CT) and Magnetic resonance (MR) angiography.
You may not qualify if:
- Patients with bleeding disorders. Patients who have severe intravenous CT or MR contrast allergy. Patients with evidence of kidney failure. Patients with severe claustrophobia. Patients with religious objections to phlebotomy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, Los Angeles
Los Angeles, California, 90024, United States
Biospecimen
whole blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aichi Chien, PhD
University of California, Los Angeles
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 14, 2021
First Posted
April 7, 2022
Study Start
December 12, 2018
Primary Completion
September 27, 2023
Study Completion
September 27, 2023
Last Updated
May 8, 2023
Record last verified: 2023-05