Aneurysm Genetic Risk in Patients With QIB Changes (AnGen)

• ClinicalTrials.gov Identifier: NCT05317169
• Recruitment Status: Recruiting
• First Posted: April 7, 2022
• Last Update Posted: April 7, 2022
• Sponsor: University of California, Los Angeles
• Information provided by (Responsible Party): Aichi Chien, PhD, University of California, Los Angeles

Study Description

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.

Condition or disease
Brain Aneurysm

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. 70 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

• Study Type: Observational
• Estimated Enrollment: 70 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Aneurysm Genetic Risk in Patients With Changes in Quantitative Imaging Biomarkers Over Time
• Actual Study Start Date: December 12, 2018
• Estimated Primary Completion Date: December 31, 2022
• Estimated Study Completion Date: June 30, 2023

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Quantitative imaging biomarkers (QIB) change [ Time Frame: 3 years ]
   Number of participants with changes in quantitative imaging biomarkers

Secondary Outcome Measures :

1. Genetic biomarkers in QIB change [ Time Frame: 3 years ]
   Number of participants with genetic biomarkers

Biospecimen Retention:   Samples With DNA

whole blood

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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.

Criteria

Inclusion Criteria:

Patients with unruptured cerebral aneurysms followed yearly using non-invasive imaging techniques including CT and 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.

Contacts and Locations

Contacts

Contact: Aichi Chien, PhD; 310-267-6837; achien@mednet.ucla.edu

Locations

United States, California

University of California, Los Angeles; Recruiting

Los Angeles, California, United States, 90024

Contact: Aichi Chien, PhD achien@mednet.ucla.edu

Contact: Victoria Rueda 310-562-9694 vrueda@mednet.ucla.edu

Principal Investigator: Aichi Chien, PhD

Sub-Investigator: Gary Duckwiler, MD

Sub-Investigator: Viktor Szeder, MD

Sub-Investigator: Geoffrey Colby, MD

Sponsors and Collaborators

University of California, Los Angeles

Investigators

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

More Information

• Responsible Party: Aichi Chien, PhD, Professor, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT05317169
• Other Study ID Numbers: 16-001867
• First Posted: April 7, 2022
• Last Update Posted: April 7, 2022
• Last Verified: April 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aichi Chien, PhD, University of California, Los Angeles:

Brain Aneurysm; Ruptured Brain Aneurysm; Aneurysm Growth; Brain Aneurysm Genetic Markers; Vascular Malformation

Additional relevant MeSH terms:

Intracranial Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases