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

NCT ID: NCT03990545

Last Updated: 2025-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-12

Study Completion Date

2021-03-05

Brief Summary

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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

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Conditions

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Intracranial Atherosclerosis Acute Stroke Transient Ischemic Attack

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cases with stroke

No interventions assigned to this group

Controls without stroke

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Jae W. Song, MD, MS

Jae W. Song, MD, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jae W Song, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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831803

Identifier Type: -

Identifier Source: org_study_id

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