Clinical trial NCT02923752: Whole Brain Vessel Wall Imaging in Stroke Patients (WISP): An International Multi-Center Registry
Official title: Whole Brain Vessel Wall Imaging in Stroke Patients (WISP): An International Multi-Center Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Vessel wall pathology findings by MRI
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Hospital of the University of Southern California
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Beijiang
country: China
facility: LiangXiang Hospital
city: Beijing
country: China
facility: Chaoyang Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing AeroSpace Center Hospital
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
city: Tianjin
country: China
facility: Tianjin First Center Hospital
city: Tianjin
country: China
facility: Tianjin Huanhu Hospital
city: ZhengZhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Zhaoyang Fan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars-Sinai Medical Center
name: Qi Yang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars-Sinai Medical Center
name: Debiao Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fan Z, Yang Q, Deng Z, Li Y, Bi X, Song S, Li D. Whole-brain intracranial vessel wall imaging at 3 Tesla using cerebrospinal fluid-attenuated T1-weighted 3D turbo spin echo. Magn Reson Med. 2017 Mar;77(3):1142-1150. doi: 10.1002/mrm.26201. Epub 2016 Feb 28.
citation: Bodle JD, Feldmann E, Swartz RH, Rumboldt Z, Brown T, Turan TN. High-resolution magnetic resonance imaging: an emerging tool for evaluating intracranial arterial disease. Stroke. 2013 Jan;44(1):287-92. doi: 10.1161/STROKEAHA.112.664680. Epub 2012 Nov 29. No abstract available.