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

NCT03990545 | Completed

• 1 other identifier: 831803
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Atherosclerosis; Acute Stroke; Transient Ischemic Attack

Keywords

intracranial atherosclerotic disease; acute stroke; transient ischemic attack; vessel wall imaging

Outcome Measures

Primary Outcomes (1)

• Prevalence of intracranial arterial wall abnormalities by sex.

  Vessel wall imaging characteristics on multicontrast MR imaging

  1 day (Evaluated at time of clinical presentation).

Study Arms (2)

Cases with stroke

Controls without stroke

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Suspected stroke patients

You may qualify if:

• 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)

You may not qualify if:

• Younger than 18 years
• Pregnant

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Intracranial Arteriosclerosis; Stroke; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Study Officials

• Jae W Song, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jae W. Song, MD, Principal Investigator

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 19, 2019
• Study Start: June 12, 2019
• Primary Completion: March 5, 2020
• Study Completion: March 5, 2021
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

US (1)