ClinicalTrials.gg
Status unknownNCT03417063Updated Jan 31, 2018

Intracranial Artery Stenosis Magnetic Resonance Imaging: Aetiology and Progression

An observational study in Ischemic Stroke, Transient Ischemic Attack and Intracranial Artery Stenosis, sponsored by Tsinghua University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-01-31.

Sponsored by Tsinghua University · Observational

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Stroke has become the leading cause of death in China. It has been shown that intracranial artery stenosis (ICAS) plays a key role in Chinese stroke patients. Although most of stenotic diseases in intracranial arteries are atherosclerotic, a substantial number of other vascular diseases, such as dissection, arteritis, moyamoya disease, and reversible cerebral vasoconstriction syndrome (RCVS), can also lead to intracranial artery luminal narrowing. It is challenging to differentiate the etiologies of ICAS relying on measuring luminal narrowing by angiographical approaches. In addition, the progression of intracranial atherosclerotic disease (ICAD) has been demonstrated to be highly associated with the risk of ischemic cerebrovascular events. However, the influence factors for ICAD progression remains unclear.

High-resolution magnetic resonance imaging (HR-MRI) has been widely used to assess ICAS diseases. The different etiologies of ICAS are differentiable by MR-MRI according to the features of location, shape, signal pattern, remodeling, and contrast enhancement. Investigators have proved that HR-MRI is a reproducible technique that may be reliably utilized to monitor the changes of ICAD during natural follow-up or medical treatment.

The ICASMAP (Intracranial Artery Stenosis MR Imaging: Aetiology and Progression) is a prospective, cross-sectional, observational, and multicenter study. The objectives of ICASMAP are to determine: 1) the spectrum of etiology of ICAS in stroke patients; and 2) the influence factors for progression of ICAD. A total of 300 patients with symptomatic stenotic disease in intracranial arteries (stenosis range: 30%-99%) will be recruited within two weeks after symptom onset from 18 different hospitals across Beijing-Tianjin-Hebei region in China within 1 year. All the patients will undergo HR-MRI for intracranial arteries at baseline, one-year, and two-years. The clinical risk factors will be collected and blood draw will be conducted. The ICASMAP study may help to improve the precise diagnosis and intervention of ICAS and stroke prevention.

02

Conditions studied

  • Ischemic Stroke
  • Transient Ischemic Attack
  • Intracranial Artery Stenosis

Keywords

  • Intracranial artery
  • Atherosclerosis
  • Intracranial artery stenosis
  • High-Resolution Magnetic Resonance
03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 300 is close to the median of 300 across 771 observational studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Tsinghua University is the lead sponsor of 27 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

In this study, we plan to recruit patients with recent transient ischemic attack or ischemic stoke within two weeks after symptom onset and intracranial artery stenosis (30%-99%) at least in intracranial internal carotid artery,basilar artery, M1 segment of middle cerebral artery, A1 segment of anterior cerebral artery, or P1 segment of posterior cerebral artery determined by computed tomography angiography or magnetic resonance angiography. The patients will be recruited from 18 hospitals in Beijing-Tianjin-Hebei area of China.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with recent or ischemic stoke within two weeks after symptom onset and intracranial artery stenosis (30%-99%) at least in intracranial internal carotid artery,basilar artery, M1 segment of middle cerebral artery , A1 segment of anterior cerebral artery, or P1 segment of posterior cerebral artery determined by computed tomography angiography or magnetic resonance (MR) angiography.

Exclusion criteria

Exclusion Criteria:

  • Patients with specific carotid artery atherosclerotic plaques
  • Patients with evidence of may causing cardiac thrombosis disease
  • Patients with claustrophobia
  • Patients with to MR imaging
  • Patients with heart or respiratory failure
  • Patients with renal insufficiency (serum creatinine >133umol/L)
  • Patients with serious disturbance of consciousness
  • Patients with brain tumors
  • Patients with cerebral hemorrhage
  • Pregnant woman or plan to pregnant within recent 2 years
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Progression of plaque burden

    Maximum wall thickness

    Time frame: 24 months

Secondary outcomes

  1. Progression of luminal stenosis

    Mild (\<50%), moderate (50-70%), severe (70-99%), and occlusion

    Time frame: 24 months

  2. Progression of plaque components

    Presence of intraplaque hemorrhage

    Time frame: 24 months

  3. cerebrovascular events

    ischemic stroke or transient ischemia attack

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
  • Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University
    Beijing, 100084, China
    Recruiting
    • Le He, MD · Contacthele0806@aliyun.com · 861062796175
    • Xihai Zhao, MD, PhD · Principal investigator
08

References and documents

Publications

  • Wang Y, Zhao X, Liu L, Soo YO, Pu Y, Pan Y, Wang Y, Zou X, Leung TW, Cai Y, Bai Q, Wu Y, Wang C, Pan X, Luo B, Wong KS; CICAS Study Group. Prevalence and outcomes of symptomatic intracranial large artery stenoses and occlusions in China: the Chinese Intracranial Atherosclerosis (CICAS) Study. Stroke. 2014 Mar;45(3):663-9. doi: 10.1161/STROKEAHA.113.003508. Epub 2014 Jan 30. PubMed 24481975 ↗
  • Ahn SH, Lee J, Kim YJ, Kwon SU, Lee D, Jung SC, Kang DW, Kim JS. Isolated MCA disease in patients without significant atherosclerotic risk factors: a high-resolution magnetic resonance imaging study. Stroke. 2015 Mar;46(3):697-703. doi: 10.1161/STROKEAHA.114.008181. Epub 2015 Jan 27. Erratum In: Stroke. 2015 Sep;46(9):e222. doi: 10.1161/STR.0000000000000077. PubMed 25628303 ↗
  • Hart RG, Diener HC, Coutts SB, Easton JD, Granger CB, O'Donnell MJ, Sacco RL, Connolly SJ; Cryptogenic Stroke/ESUS International Working Group. Embolic strokes of undetermined source: the case for a new clinical construct. Lancet Neurol. 2014 Apr;13(4):429-38. doi: 10.1016/S1474-4422(13)70310-7. PubMed 24646875 ↗
  • Wang Y, Xu J, Zhao X, Wang D, Wang C, Liu L, Wang A, Meng X, Li H, Wang Y. Association of hypertension with stroke recurrence depends on ischemic stroke subtype. Stroke. 2013 May;44(5):1232-7. doi: 10.1161/STROKEAHA.111.000302. Epub 2013 Feb 26. PubMed 23444308 ↗
  • Gorelick PB, Wong KS, Bae HJ, Pandey DK. Large artery intracranial occlusive disease: a large worldwide burden but a relatively neglected frontier. Stroke. 2008 Aug;39(8):2396-9. doi: 10.1161/STROKEAHA.107.505776. Epub 2008 Jun 5. PubMed 18535283 ↗
  • Choi YJ, Jung SC, Lee DH. Vessel Wall Imaging of the Intracranial and Cervical Carotid Arteries. J Stroke. 2015 Sep;17(3):238-55. doi: 10.5853/jos.2015.17.3.238. Epub 2015 Sep 30. PubMed 26437991 ↗
  • Mossa-Basha M, Hwang WD, De Havenon A, Hippe D, Balu N, Becker KJ, Tirschwell DT, Hatsukami T, Anzai Y, Yuan C. Multicontrast high-resolution vessel wall magnetic resonance imaging and its value in differentiating intracranial vasculopathic processes. Stroke. 2015 Jun;46(6):1567-73. doi: 10.1161/STROKEAHA.115.009037. Epub 2015 May 7. PubMed 25953365 ↗
  • Han Y, Zhang R, Yang D, Li D, Han H, Qiao H, Chen S, Wang Y, Yu M, Hong Y, Wang Z, Zhao X, Liu G. Risk Factors for Asymptomatic and Symptomatic Intracranial Atherosclerosis Determined by Magnetic Resonance Vessel Wall Imaging in Chinese Population: A Case-Control Study. Ther Clin Risk Manag. 2022 Jan 12;18:61-70. doi: 10.2147/TCRM.S335401. eCollection 2022. PubMed 35058694 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2017 (actual). Primary completion is estimated for Mar 2021, 41 months after the start.

Of 394 non-industry observational studies under Ischemic Stroke, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 140. This study's planned 41 months is below that.

Counting every sponsor, half of 436 studies reached it within 53 months; a quarter within 24 and three quarters within 127.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 24, 2018
First posted
Jan 31, 2018
StartActual
Oct 14, 2017
Primary completionEst.
Mar 25, 2021
CompletionEst.
Mar 25, 2022
Last update
Jan 31, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03417063
Lead sponsor
Tsinghua University
Collaborators
Xuanwu Hospital, Beijing, Beijing Tiantan Hospital, Beijing Hospital, 309th Hospital of Chinese People's Liberation Army, Navy General Hospital, Beijing, First Hospitals affiliated to the China PLA General Hospital, Beijing Huairou Hospital, Beijing Pinggu District Hospital, Beijing Shuyi Hospital, Tianjin First Central Hospital, Tianjin 4th Centre Hospital, Tianjin Union Medical Center, Hebei Medical University Third Hospital, Affiliated Hospital of Chengde Medical University, Tangshan Gongren Hospital, The First Affiliated Hospital of Hebei North University, Cangzhou People's Hospital, Harrison International Peace Hospital
Responsible party
Xihai Zhao (Professor, Tsinghua University) — Principal investigator
First posted
Jan 31, 2018
Start date
Oct 14, 2017
Primary completion
Mar 25, 2021 (estimated)
Completion
Mar 25, 2022 (estimated)
Last update
Jan 31, 2018

Study contacts

Dongye Li, MD
Contact
dongyeli1988@126.com
1561153321
Yongjun Han, MD
Contact
lalyn0322@hotmail.com
15116962341
Xihai Zhao, MD, PhD
principal investigator · Tsinghua University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion