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出境医 / 临床实验 / Vessel Wall MR Imaging to Explore Sex-Differences of Intracranial Arterial Wall Changes After Suspected Stroke
Vessel Wall MR Imaging to Explore Sex-Differences of Intracranial Arterial Wall Changes After Suspected Stroke
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 |
|---|
| Intracranial Atherosclerosis Acute Stroke Transient Ischemic Attack |
Study Design
| Study Type : | Observational |
| Estimated 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 : | June 12, 2019 |
| Estimated Primary Completion Date : | December 2022 |
| Estimated Study Completion Date : | December 2022 |
Arms and Interventions
| Group/Cohort |
|---|
| Cases with stroke |
| Controls without stroke |
Outcome Measures
Primary Outcome Measures :
- 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
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Suspected stroke patients
Criteria
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
Contacts
| Contact: Jae W Song, MD, MS | 215-349-8023 | jae.song@pennmedicine.upenn.edu | |
| Contact: Morgan Burke, BS | morgan.burke@pennmedicine.upenn.edu |
Locations
| United States, Pennsylvania | |
| Hospital of the University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Jae W Song, MD 215-349-8023 jae.song@pennmedicine.upenn.edu | |
Sponsors and Collaborators
University of Pennsylvania
Investigators
| Principal Investigator: | Jae W Song, MD | University of Pennsylvania |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 14, 2019 | ||||||||
| First Posted Date | June 19, 2019 | ||||||||
| Last Update Posted Date | April 27, 2021 | ||||||||
| Actual Study Start Date | June 12, 2019 | ||||||||
| Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Vessel Wall MR Imaging to Explore Sex-Differences of Intracranial Arterial Wall Changes After Suspected Stroke | ||||||||
| Official Title | Vessel Wall MR Imaging to Explore Sex-Differences of Intracranial Arterial Wall Changes After Suspected Stroke | ||||||||
| 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. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Suspected stroke patients | ||||||||
| Condition |
|
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| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts |
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
132 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 2022 | ||||||||
| Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years to 100 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03990545 | ||||||||
| Other Study ID Numbers | 831803 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Jae W. Song, MD, MS, University of Pennsylvania | ||||||||
| Study Sponsor | University of Pennsylvania | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | University of Pennsylvania | ||||||||
| Verification Date | April 2021 | ||||||||
