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Whole Brain Vessel Wall Imaging in Stroke Patients (WISP): An International Multi-Center Registry (WISP)

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ClinicalTrials.gov Identifier: NCT02923752
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Zhaoyang Fan, PhD, Cedars-Sinai Medical Center

Brief Summary:
This is a new vessel wall imaging-based stroke registry which will investigate the clinical utility of the whole-brain intracranial vessel wall Magnetic Resonance Imaging (MRI) technique in assessing the etiologies in patients with ischemic stroke.

Condition or disease Intervention/treatment
Ischemic Stroke Device: MRI

Detailed Description:
The registry will focus on investigating the utility of whole-brain vessel wall MRI techniques in assessing the etiologies in patients with recent ischemic stroke. Patients who have had ischemic stroke (as confirmed by diffusion weighted MRI) and have had or will undergo 3D whole-brain vessel wall MRI within 8 weeks of symptom onset will be recruited into this study. It is anticipated that a total of 1000 subjects will be recruited from Feb 2017 to Feb 2019. Approximately 12 centers in the US and China will participate in the registry. MRI whole-brain vessel wall images will be analyzed for detection and characteristics of various vessel wall pathologies and association between vessel wall imaging findings and patient's clinical information.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Whole Brain Vessel Wall Imaging in Stroke Patients (WISP): An International Multi-Center Registry
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: MRI
    Contrast-enhanced MRI


Primary Outcome Measures :
  1. Vessel wall pathology findings by MRI [ Time Frame: baseline ]
    To identify vessel wall pathologies such as atherosclerosis, dissection, vasculitis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients had recent ischemic stroke and have had or will undergo 3D whole-brain vessel wall MRI within 8 weeks of symptom onset.
Criteria

Inclusion Criteria:

  • Male or female ≥ 18 years of age
  • Ischemic stroke onset within 8 weeks and confirmed by diffusion weighted MRI
  • Ability to read and understand informed consent

Exclusion Criteria:

  • The cause of stroke has been confirmed to be related to cardiac or extracranial carotid or aorta pathologies.
  • Contraindications to MR imaging including mechanically, magnetically, or electrically activated implants, ferromagnetic implants and ferromagnetic foreign bodies, pregnancy.
  • Inability to tolerate MRI imaging secondary to an inability to lie supine or severe claustrophobia.
  • Non-compliant with visit instructions, including inability to lie still, hold breath or follow procedure instructions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923752


Contacts
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Contact: Zhaoyang Fan, PhD 310 248-8661 zhaoyang.fan@cshs.org
Contact: Qi Yang, MD, PhD 310 248-8676 qi.yang@cshs.org

Locations
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United States, California
Keck Hospital of the University of Southern California Not yet recruiting
Los Angeles, California, United States, 90033
Contact: May Anne Kim-Tenser, MD         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Shlee Song, MD         
Torrance Memorial Medical Center Not yet recruiting
Torrance, California, United States, 90505
Contact: Edward S. Nazareth , Stroke Coordinator         
China
LiangXiang Hospital Recruiting
Beijiang, China, 100081
Contact: Huan Yu, MD         
Chaoyang Hospital, Capital Medical University Recruiting
Beijing, China, 100043
Contact: Tao Jiang, MD,PhD         
Beijing AeroSpace Center Hospital Recruiting
Beijing, China, 100049
Contact: Bin Cui, MD, PhD         
Xuanwu Hospital, Capital Medical University Recruiting
Beijing, China, 100053
Contact: Xunming Ji, MD., PhD         
West China Hospital, Sichuan University Recruiting
Chengdu, China, 610041
Contact: Jiayu Sun, MD, PhD         
Fujian Medical University Union Hospital Recruiting
Fuzhou, China, 350001
Contact: Bin Sun, MD, PhD         
Tianjin First Center Hospital Recruiting
Tianjin, China, 300192
Contact: Shuang Xia, MD, PhD         
Tianjin Huanhu Hospital Recruiting
Tianjin, China, 300350
Contact: Tong Han, MD, PhD         
The First Affiliated Hospital of Zhengzhou University Recruiting
ZhengZhou, China, 450052
Contact: Jingliang Cheng, MD, PhD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Zhaoyang Fan, PhD Cedars-Sinai Medical Center
Principal Investigator: Qi Yang, MD,PhD Cedars-Sinai Medical Center
Principal Investigator: Debiao Li, PhD Cedars-Sinai Medical Center

Publications of Results:
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Responsible Party: Zhaoyang Fan, PhD, Technical Director, 3T MRI, Biomedical Imaging Research Institute, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02923752     History of Changes
Other Study ID Numbers: 46315
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases