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

Ischemic Stroke Clinical Trial

— WISP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02923752
• Other study ID #: 46315
• Status: Recruiting
• Start date: February 1, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: August 2018
• Source: Cedars-Sinai Medical Center
• Contact: Zhaoyang Fan, PhD
• Phone: 310 248-8661
• Email: zhaoyang.fan[@]cshs.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Device:
• MRI
Contrast-enhanced MRI

Locations

Country	Name	City	State
China	LiangXiang Hospital	Beijiang
China	Beijing AeroSpace Center Hospital	Beijing
China	Chaoyang Hospital, Capital Medical University	Beijing
China	Xuanwu Hospital, Capital Medical University	Beijing
China	West China Hospital, Sichuan University	Chengdu
China	Fujian Medical University Union Hospital	Fuzhou
China	Tianjin First Center Hospital	Tianjin
China	Tianjin Huanhu Hospital	Tianjin
China	The First Affiliated Hospital of Zhengzhou University	ZhengZhou
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Keck Hospital of the University of Southern California	Los Angeles	California
United States	Torrance Memorial Medical Center	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Countries where clinical trial is conducted

United States,  China, 

References & Publications (2)

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. — View 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 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vessel wall pathology findings by MRI	To identify vessel wall pathologies such as atherosclerosis, dissection, vasculitis	baseline