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

Acute Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03990545
• Other study ID #: 831803
• Status: Completed
• Start date: June 12, 2019
• Est. completion date: March 5, 2021

Study information

• Verified date: December 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 5, 2021
• Est. primary completion date: March 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Stroke
• Atherosclerosis
• Intracranial Arteriosclerosis
• Intracranial Atherosclerosis
• Ischemic Attack, Transient
• Stroke
• Transient Ischemic Attack

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of intracranial arterial wall abnormalities by sex.	Vessel wall imaging characteristics on multicontrast MR imaging	1 day (Evaluated at time of clinical presentation).