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

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03990545
• Collaborator: (none)
• Enrollment: 132
• Location: 1
• Anticipated Duration (Months): 65.7
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intracranial Atherosclerosis; Acute Stroke; Transient Ischemic Attack

Study Design

• Study Type: Observational
• Anticipated Enrollment: 132 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Vessel Wall MR Imaging to Explore Sex-Differences of Intracranial Arterial Wall Changes After Suspected Stroke
• Actual Study Start Date: Jun 12, 2019
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Cases with stroke
Controls without stroke

Outcome Measures

Primary Outcome Measures

1. Prevalence of intracranial arterial wall abnormalities by sex. [1 day (Evaluated at time of clinical presentation).]

   Vessel wall imaging characteristics on multicontrast MR imaging

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

• Principal Investigator: Jae W Song, MD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jae W. Song, MD, MS, Jae W. Song, MD, Principal Investigator, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03990545
• Other Study ID Numbers: 831803
• First Posted: Jun 19, 2019
• Last Update Posted: Aug 22, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jae W. Song, MD, MS, Jae W. Song, MD, Principal Investigator, University of Pennsylvania: intracranial atherosclerotic disease; acute stroke; transient ischemic attack; vessel wall imaging
• Additional relevant MeSH terms: Stroke; Ischemic Attack, Transient; Intracranial Arteriosclerosis; Atherosclerosis

Study Results

No Results Posted as of Aug 22, 2022