Ischemic StrokeWISPNCT02923752
Whole Brain Vessel Wall Imaging in Stroke Patients (WISP): An International Multi-Center Registry
An observational study of Ischemic Stroke, run by Cedars-Sinai Medical Center at 12 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 1 Feb 2017to 1 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
China9 sites, 9 recruiting
- Recruiting
LiangXiang Hospital
Beijiang, 100081
Huan Yu, MD
- Recruiting
Chaoyang Hospital, Capital Medical University
Beijing, 100043
Tao Jiang, MD,PhD
- Recruiting
Beijing AeroSpace Center Hospital
Beijing, 100049
Bin Cui, MD, PhD
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, 100053
Xunming Ji, MD., PhD
- Recruiting
West China Hospital, Sichuan University
Chengdu, 610041
Jiayu Sun, MD, PhD
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, 350001
Bin Sun, MD, PhD
- Recruiting
Tianjin First Center Hospital
Tianjin, 300192
Shuang Xia, MD, PhD
- Recruiting
Tianjin Huanhu Hospital
Tianjin, 300350
Tong Han, MD, PhD
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450052
Jingliang Cheng, MD, PhD
United States3 sites, 3 recruiting
- Not yet recruiting
Keck Hospital of the University of Southern California
Los Angeles, California, 90033
May Anne Kim-Tenser, MD
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Shlee Song, MD
- Not yet recruiting
Torrance Memorial Medical Center
Torrance, California, 90505
Edward S. Nazareth, Stroke Coordinator
About this study
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.
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- MRI
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Contrast-enhanced MRI
What is being measured
The primary outcome is the main question the study is designed to answer.
Vessel wall pathology findings by MRI
To identify vessel wall pathologies such as atherosclerosis, dissection, vasculitis
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start1 Feb 2017
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoyang Fan, PhD, Cedars-Sinai Medical Center
- Investigators
- Zhaoyang Fan, PhD, Principal investigator, Cedars-Sinai Medical CenterQi Yang, MD,PhD, Principal investigator, Cedars-Sinai Medical CenterDebiao Li, PhD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923752
- Sponsor's protocol ID
- 46315
- Acronym
- WISP
- Status last verified
- Aug 2018
- First submitted
- 3 Oct 2016
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26923198Bodle 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.
PubMed 23204050
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Brain Vessel Wall Imaging in Stroke Patients (WISP): An International Multi-Center Registry
- ClinicalTrials.gov ID
- NCT02923752
- Acronym / sponsor ID
- WISP / 46315
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIContrast-enhanced MRI | Device | – |
Primary outcome
Vessel wall pathology findings by MRI
Time frame: baseline
To identify vessel wall pathologies such as atherosclerosis, dissection, vasculitis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Results publication: PubMed 26923198Fan 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.
- Results publication: PubMed 23204050Bodle 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaoyang Fan, PhD principal investigator
Cedars-Sinai Medical Center
Qi Yang, MD,PhD principal investigator
Cedars-Sinai Medical Center
Debiao Li, PhD principal investigator
Cedars-Sinai Medical Center
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Cedars-Sinai Medical Center at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaoyang Fan, PhD (310 248-8661, zhaoyang.fan@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vessel wall pathology findings by MRI (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02923752, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.