AzTrials
AzTrials

Ischemic StrokeNCT03417063

Intracranial Artery Stenosis Magnetic Resonance Imaging: Aetiology and Progression

An observational study of Ischemic Stroke and Transient Ischemic Attack, run by Tsinghua University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
How many people
300 participants
Where
1 siteChina
Study dates
14 Oct 2017to 25 Mar 2022
How long will I take part?
2 Years
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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 (MR) angiography.

Who cannot join

  • Patients with specific carotid artery atherosclerotic plaques
  • Patients with evidence of may causing cardiac thrombosis disease
  • Patients with claustrophobia
  • Patients with contraindications to MR imaging
  • Patients with heart or respiratory failure
  • Patients with renal insufficiency (serum creatinine >133umol/L)
Show all 10Show fewer
  • Patients with serious disturbance of consciousness
  • Patients with brain tumors
  • Patients with cerebral hemorrhage
  • Pregnant woman or plan to pregnant within recent 2 years

Trial locations and contacts

1 site in 1 country.

Dongye Li, MD contact

1561153321

dongyeli1988@126.com

Yongjun Han, MD contact

15116962341

lalyn0322@hotmail.com

China1 site, 1 recruiting

  • Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University

    Beijing, 100084

    Le He, MD, 861062796175, hele0806@aliyun.com

    Xihai Zhao, MD, PhD

    Recruiting

Other trials in China

About this study

Official title: Intracranial Artery Stenosis Magnetic Resonance Imaging: Aetiology and Progression (ICASMAP)

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.

Keywords
Intracranial artery, Atherosclerosis, Intracranial artery stenosis, High-Resolution Magnetic Resonance
Medical subject headings
Ischemic Stroke, Ischemic Attack, Transient, Atherosclerosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression of plaque burden

    Maximum wall thickness

    Measured: 24 months

Secondary outcomes (3)

  1. Progression of luminal stenosis

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

    Measured: 24 months

  2. Progression of plaque components

    Presence of intraplaque hemorrhage

    Measured: 24 months

  3. cerebrovascular events

    ischemic stroke or transient ischemia attack

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2018
  2. Study start14 Oct 2017
  3. Primary completion25 Mar 2021 (estimated)
  4. Study completion25 Mar 2022 (estimated)

Resources

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
Case only
Time perspective
Prospective
Enrolment
300 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03417063
Sponsor's protocol ID
D171100003017003
Status last verified
Jan 2018
First submitted
24 Jan 2018
Last updated
31 Jan 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    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

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Stroke and Transient Ischemic Attack, run by Tsinghua University at 1 site in China.

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 1 inclusion and 10 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 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 Dongye Li, MD (1561153321, dongyeli1988@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression of plaque burden (time frame: 24 months). 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 NCT03417063, which also lists 8 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 31 Jan 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in