- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03990545
Vessel Wall MR Imaging to Explore Sex-Differences of Intracranial Arterial Wall Changes After Suspected Stroke
December 15, 2022 updated by: Jae W. Song, MD, MS, University of Pennsylvania
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
11
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 98 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Suspected stroke patients
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Cases with stroke
|
Controls without stroke
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of intracranial arterial wall abnormalities by sex.
Time Frame: 1 day (Evaluated at time of clinical presentation).
|
Vessel wall imaging characteristics on multicontrast MR imaging
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1 day (Evaluated at time of clinical presentation).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jae W Song, MD, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 12, 2019
Primary Completion (Actual)
March 5, 2020
Study Completion (Actual)
March 5, 2021
Study Registration Dates
First Submitted
June 14, 2019
First Submitted That Met QC Criteria
June 18, 2019
First Posted (Actual)
June 19, 2019
Study Record Updates
Last Update Posted (Actual)
December 20, 2022
Last Update Submitted That Met QC Criteria
December 15, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Brain Ischemia
- Intracranial Arterial Diseases
- Stroke
- Ischemic Attack, Transient
- Atherosclerosis
- Intracranial Arteriosclerosis
Other Study ID Numbers
- 831803
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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