NCT02705599

Brief Summary

Predictors of the risk of recurrent stroke for patients with symptomatic intracranial atherosclerotic stenosis (ICAS) remain unknown. The study will be to explore the stroke mechanism evolution in patients with ICAS by multi-model magnetic resonance imaging (MRI) which consists of diffusion-weighted imaging (DWI) and high-resolution MRI (HRMRI). The patients with symptomatic ICAS will undergo multi-model MRI. The baseline data, infarct patterns on DWI, and plaque features on HRMRI will be collected. The stroke mechanisms will be determined by the infarct patterns. During the 2 years follow-up, the recurrent ischemic events will be recorded. By comparing the baseline data, infarct patterns, and plaque features in patients with and without recurrent strokes, the high-risk features of patients with symptomatic ICAS will be identified. The evaluation of stroke mechanisms of patients with symptomatic ICAS will be summarized.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

August 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 10, 2016

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 4, 2023

Status Verified

April 1, 2023

Enrollment Period

6.3 years

First QC Date

March 7, 2016

Last Update Submit

April 3, 2023

Conditions

Keywords

Ischemic strokeHigh resolution MRIPerfusionMechanism

Outcome Measures

Primary Outcomes (1)

  • Ischemic stroke event (in the stenotic vascular territory)

    The primary outcome will include ischemic stroke (in the stenotic vascular territory) and vascular death.

    To 2 years

Secondary Outcomes (1)

  • Ischemic stroke event (in the non-stenotic vascular territory)

    To 2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Symtomatic patients with intracranial atherosclerostic stenosis

You may not qualify if:

  • Non-atherosclerosis vasculopathy such as vasculitis and arterial dissection diagnosed by comprehensive laboratory work (such as erythrocyte sedimentation rate or C-reactive protein elevations, antinuclear antibody, or antiphospholipid antibody positivity), vascular imaging, and clinical evaluation;
  • Contraindication to MR examination, medical instability precluding MR examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Beijing Tiantan Hospital

Beijing, 100853, China

Location

Related Publications (8)

  • Lyu J, Ma N, Liebeskind DS, Wang DJ, Ma L, Xu Y, Wang T, Miao Z, Lou X. Arterial Spin Labeling Magnetic Resonance Imaging Estimation of Antegrade and Collateral Flow in Unilateral Middle Cerebral Artery Stenosis. Stroke. 2016 Feb;47(2):428-33. doi: 10.1161/STROKEAHA.115.011057. Epub 2016 Jan 5.

    PMID: 26732570BACKGROUND
  • Ma N, Jiang WJ, Lou X, Ma L, Du B, Cai JF, Zhao TQ. Arterial remodeling of advanced basilar atherosclerosis: a 3-tesla MRI study. Neurology. 2010 Jul 20;75(3):253-8. doi: 10.1212/WNL.0b013e3181e8e714.

    PMID: 20644151BACKGROUND
  • Lopez-Cancio E, Matheus MG, Romano JG, Liebeskind DS, Prabhakaran S, Turan TN, Cotsonis GA, Lynn MJ, Rumboldt Z, Chimowitz MI. Infarct patterns, collaterals and likely causative mechanisms of stroke in symptomatic intracranial atherosclerosis. Cerebrovasc Dis. 2014;37(6):417-22. doi: 10.1159/000362922. Epub 2014 Jul 4.

    PMID: 25011483BACKGROUND
  • Hou Z, Li M, Lyu J, Xu Z, Liu Y, He J, Jing J, Wang R, Wang Y, Lou X, Miao Z, Ma N. Intraplaque Enhancement Is Associated With Artery-to-Artery Embolism in Symptomatic Vertebrobasilar Atherosclerotic Diseases. Front Neurol. 2021 Sep 1;12:680827. doi: 10.3389/fneur.2021.680827. eCollection 2021.

  • Yang M, Ma N, Liu L, Wang A, Jing J, Hou Z, Liu Y, Lou X, Miao Z, Wang Y. Intracranial collaterals and arterial wall features in severe symptomatic vertebrobasilar stenosis. Neurol Res. 2020 Aug;42(8):649-656. doi: 10.1080/01616412.2020.1782081. Epub 2020 Jun 23.

  • Xu Z, Li M, Lyu J, Hou Z, He J, Mo D, Gao F, Liu X, Sui B, Shen M, Pan Y, Wang Y, Lou X, Miao Z, Luo B, Ma N. Different risk factors in identical features of intracranial atherosclerosis plaques in the posterior and anterior circulation in high-resolution MRI. Ther Adv Neurol Disord. 2020 Mar 13;13:1756286420909991. doi: 10.1177/1756286420909991. eCollection 2020.

  • Xu Z, Li M, Hou Z, Lyu J, Zhang N, Lou X, Miao Z, Ma N. Association between basilar artery configuration and Vessel Wall features: a prospective high-resolution magnetic resonance imaging study. BMC Med Imaging. 2019 Dec 26;19(1):99. doi: 10.1186/s12880-019-0388-3.

  • Ma N, Xu Z, Lyu J, Li M, Hou Z, Liu Y, Yang M, Mo D, Gao F, Song L, Sun X, Liu L, Liu X, Sui B, Shen M, Ma L, Wang Y, Wang Y, Miao Z, Lou X. Association of Perforator Stroke After Basilar Artery Stenting With Negative Remodeling. Stroke. 2019 Mar;50(3):745-749. doi: 10.1161/STROKEAHA.118.023838.

MeSH Terms

Conditions

StrokeIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Xin Lou, M.D. Ph.D.

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR
  • Ning Ma, M.D. Ph.D.

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Chief

Study Record Dates

First Submitted

March 7, 2016

First Posted

March 10, 2016

Study Start

August 1, 2014

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

April 4, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations