NCT02923752

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Geographic Reach
2 countries

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

2.5 years

First QC Date

October 3, 2016

Last Update Submit

August 13, 2018

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • Vessel wall pathology findings by MRI

    To identify vessel wall pathologies such as atherosclerosis, dissection, vasculitis

    baseline

Interventions

MRIDEVICE

Contrast-enhanced MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Keck Hospital of the University of Southern California

Los Angeles, California, 90033, United States

NOT YET RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Torrance Memorial Medical Center

Torrance, California, 90505, United States

NOT YET RECRUITING

LiangXiang Hospital

Beijiang, 100081, China

RECRUITING

Chaoyang Hospital, Capital Medical University

Beijing, 100043, China

RECRUITING

Beijing AeroSpace Center Hospital

Beijing, 100049, China

RECRUITING

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, 610041, China

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, 350001, China

RECRUITING

Tianjin First Center Hospital

Tianjin, 300192, China

RECRUITING

Tianjin Huanhu Hospital

Tianjin, 300350, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, 450052, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 26923198RESULT

  • 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.

    PMID: 23204050RESULT

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaoyang Fan, PhD

CONTACT

310 248-8661zhaoyang.fan@cshs.org

Qi Yang, MD, PhD

CONTACT

310 248-8676qi.yang@cshs.org

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Technical Director, 3T MRI, Biomedical Imaging Research Institute

Study Record Dates

First Submitted

October 3, 2016

First Posted

October 5, 2016

Study Start

February 1, 2017

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

August 14, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(3)CN(9)