Brain AneurysmAnGenNCT05317169
Aneurysm Genetic Risk in Patients With QIB Changes
An observational study of Brain Aneurysm, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Aneurysm
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2018to 27 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: UCLA patients who come for yearly CT or MR angiography for cerebral aneurysm surveillance.
Who may be able to join
- Patients with unruptured cerebral aneurysms followed yearly using non-invasive imaging techniques including Computed tomography (CT) and Magnetic resonance (MR) angiography.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90024
Aichi Chien, PhD, achien@mednet.ucla.edu
Victoria Rueda, 310-562-9694, vrueda@mednet.ucla.edu
About this study
Official title: Aneurysm Genetic Risk in Patients With Changes in Quantitative Imaging Biomarkers Over Time
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.
Read the detailed description
The objective of this study is to investigate intracranial aneurysms that have been followed with clinical 3D aneurysm images and create a matrix that can identify the risk of growth by integrating QIB with genetic predisposition risk factors. 120 Patients who have been followed by clinical aneurysm imaging study will be enrolled in this study. The study team will collect blood samples from the patients for genetic analysis.
To find the genetic factors, the blood samples will be processed with a focus on genetic variants 1) in pathways involved in endothelial and vascular function and 2) previously identified in genome-wide association studies of aneurysm risk. These analyses will include both common polymorphisms and rare alterations. These biomarkers have important implications for facilitating identification of high-risk subgroups for aneurysm growth and the development of improved evidence-based decision-making.
The investigators will perform aneurysm 3D analysis based on the aneurysm images to extract aneurysm QIB for these cases. Shape parameters such as aneurysm surface area shape indices will be collected for individual aneurysms as well as parameters capturing the aneurysm blood flow pattern. The study plans to address whether certain genetic variants for vascular function are present in patients with QIB change over time.
- Conditions
- Brain Aneurysm
- Keywords
- Brain Aneurysm, Ruptured Brain Aneurysm, Aneurysm Growth, Brain Aneurysm Genetic Markers, Vascular Malformation
- Medical subject headings
- Intracranial Aneurysm, Vascular Malformations
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative imaging biomarkers (QIB) change
Number of participants with changes in quantitative imaging biomarkers
Measured: 3 years
Secondary outcomes (1)
Genetic biomarkers in QIB change
Number of participants with genetic biomarkers
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start12 Dec 2018
- Primary completion27 Sep 2023 (estimated)
- Study completion27 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain AneurysmStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aichi Chien, PhD, University of California, Los Angeles
- Investigators
- Aichi Chien, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317169
- Sponsor's protocol ID
- 16-001867
- Acronym
- AnGen
- Status last verified
- May 2023
- First submitted
- 14 Dec 2021
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aneurysm Genetic Risk in Patients With Changes in Quantitative Imaging Biomarkers Over Time
- ClinicalTrials.gov ID
- NCT05317169
- Acronym / sponsor ID
- AnGen / 16-001867
- Conditions
- Brain Aneurysm
- Keywords
- Brain Aneurysm, Ruptured Brain Aneurysm, Aneurysm Growth, Brain Aneurysm Genetic Markers, Vascular Malformation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 27 Sep 2023 (estimated)
- Study completion
- 27 Sep 2023 (estimated)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of this study is to investigate intracranial aneurysms that have been followed with clinical 3D aneurysm images and create a matrix that can identify the risk of growth by integrating QIB with genetic predisposition risk factors. 120 Patients who have been followed by clinical aneurysm imaging study will be enrolled in this study. The study team will collect blood samples from the patients for genetic analysis.
To find the genetic factors, the blood samples will be processed with a focus on genetic variants 1) in pathways involved in endothelial and vascular function and 2) previously identified in genome-wide association studies of aneurysm risk. These analyses will include both common polymorphisms and rare alterations. These biomarkers have important implications for facilitating identification of high-risk subgroups for aneurysm growth and the development of improved evidence-based decision-making.
The investigators will perform aneurysm 3D analysis based on the aneurysm images to extract aneurysm QIB for these cases. Shape parameters such as aneurysm surface area shape indices will be collected for individual aneurysms as well as parameters capturing the aneurysm blood flow pattern. The study plans to address whether certain genetic variants for vascular function are present in patients with QIB change over time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- UCLA patients who come for yearly CT or MR angiography for cerebral aneurysm surveillance.
Key inclusion criteria (1 listed)
- Patients with unruptured cerebral aneurysms followed yearly using non-invasive imaging techniques including Computed tomography (CT) and Magnetic resonance (MR) angiography.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantitative imaging biomarkers (QIB) change
Time frame: 3 years
Number of participants with changes in quantitative imaging biomarkers
1 secondary outcome
Genetic biomarkers in QIB change
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
Related trials for Brain Aneurysm
Recruiting
The Use of p48/64 MW HPC Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneurysms
Hemorrhagic Stroke, Aneurysm, Intracranial
Enrolling by invitationObservational study
Multimodal Physiologic State Intelligence Study
Heart Failure, Cardiomyopathies
Active, not recruitingObservational study
Florida Cerebrovascular Disease Biorepository and Genomics Center
Cerebrovascular Disease, Ischemic Stroke
Recruiting
Multimodal Biocollection Linked to the French Register of Intracranial Aneurysms
Aneurysm, Brain Aneurysm
RecruitingObservational study
PMCF Registry to Describe the Safety and Performance of p64, p48 MW and p64 MW in France
Intracranial Aneurysms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aichi Chien, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Aneurysm, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aichi Chien, PhD (310-267-6837, achien@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative imaging biomarkers (QIB) change (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023; AzTrials last refreshed its copy on 2 Nov 2026.