Vessel Wall MR Imaging to Explore Sex-Differences of Intracranial Arterial Wall Changes After Suspected Stroke

Completed

• Conditions: Acute Stroke; Intracranial Atherosclerosis; Transient Ischemic Attack

• Registration Number: NCT03990545
• Lead Sponsor: University of Pennsylvania

Brief Summary

Despite advances in stroke care, women continue to face worse outcomes after stroke than men. This disparity in outcomes may be related to biologic sex-differences that manifest in the development and progression of atherosclerosis. Decades of cyclic changes in the hormonal milieu lead to different metabolic profiles in women. These changes may also explain sex-differences in risk factor profiles of atherogenesis and plaque composition. The investigators' objective is to conduct a cross-sectional MR imaging study of suspected stroke patients to compare the burden and composition of intracranial atherosclerosis and risk factors between men and women. Results from this study are expected to show that sex and sex-specific risk factors should be considered at the outset of stroke evaluation for risk-stratification. In the era of precision medicine, the investigators propose the role of sex should be a starting point in the clinical evaluation of stroke.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-12
• Study First Submitted: 2019-06-14
• Study First Submitted QC: 2019-06-18
• Study First Posted: 2019-06-19
• Primary Completion: 2020-03-05
• Study Completion: 2021-03-05
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-15
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Older than 18 years
• Suspected stroke patients
• No contraindications for an MRI exam or gadolinium intravenous contrast
• No need for an emergent interventional treatment (e.g., thrombectomy)

Exclusion Criteria

• Younger than 18 years
• Pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of intracranial arterial wall abnormalities by sex.	1 day (Evaluated at time of clinical presentation).	Vessel wall imaging characteristics on multicontrast MR imaging

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States