Aneurysm Genetic Risk in Patients With QIB Changes (AnGen)

May 4, 2023 updated by: Aichi Chien, PhD, University of California, Los Angeles

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90024
        • Recruiting
        • University of California, Los Angeles
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aichi Chien, PhD
        • Sub-Investigator:
          • Gary Duckwiler, MD
        • Sub-Investigator:
          • Viktor Szeder, MD
        • Sub-Investigator:
          • Geoffrey Colby, MD
        • Sub-Investigator:
          • Pablo Villablanca, MD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

UCLA patients who come for yearly CT or MR angiography for cerebral aneurysm surveillance.

Description

Inclusion Criteria:

Patients with unruptured cerebral aneurysms followed yearly using non-invasive imaging techniques including Computed tomography (CT) and Magnetic resonance (MR) angiography.

Exclusion Criteria:

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative imaging biomarkers (QIB) change
Time Frame: 3 years
Number of participants with changes in quantitative imaging biomarkers
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genetic biomarkers in QIB change
Time Frame: 3 years
Number of participants with genetic biomarkers
3 years

Collaborators and Investigators

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

Sponsor

University of California, Los Angeles

Investigators

  • Principal Investigator: Aichi Chien, PhD, University of California, Los Angeles

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 (Actual)

December 12, 2018

Primary Completion (Anticipated)

September 27, 2023

Study Completion (Anticipated)

September 27, 2023

Study Registration Dates

First Submitted

December 14, 2021

First Submitted That Met QC Criteria

April 4, 2022

First Posted (Actual)

April 7, 2022

Study Record Updates

Last Update Posted (Actual)

May 8, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-001867

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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