Intracranial Artery Stenosis Magnetic Resonance Imaging: Aetiology and Progression

NCT ID: NCT03417063

Last Updated: 2018-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-14

Study Completion Date

2022-03-25

Brief Summary

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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.

Detailed Description

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Conditions

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Ischemic Stroke Transient Ischemic Attack Intracranial Artery Stenosis

Keywords

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Intracranial artery Atherosclerosis Intracranial artery stenosis High-Resolution Magnetic Resonance

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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)
* Patients with serious disturbance of consciousness
* Patients with brain tumors
* Patients with cerebral hemorrhage
* Pregnant woman or plan to pregnant within recent 2 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hospital, Beijing

OTHER

Sponsor Role collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

Beijing Hospital

OTHER_GOV

Sponsor Role collaborator

309th Hospital of Chinese People's Liberation Army

OTHER

Sponsor Role collaborator

Navy General Hospital, Beijing

OTHER

Sponsor Role collaborator

First Hospitals affiliated to the China PLA General Hospital

OTHER_GOV

Sponsor Role collaborator

Beijing Huairou Hospital

OTHER

Sponsor Role collaborator

Beijing Pinggu District Hospital

OTHER

Sponsor Role collaborator

Beijing Shuyi Hospital

OTHER

Sponsor Role collaborator

Tianjin First Central Hospital

OTHER

Sponsor Role collaborator

Tianjin 4th Centre Hospital

UNKNOWN

Sponsor Role collaborator

Tianjin Union Medical Center

OTHER

Sponsor Role collaborator

Hebei Medical University Third Hospital

OTHER

Sponsor Role collaborator

Affiliated Hospital of Chengde Medical University

OTHER

Sponsor Role collaborator

Tangshan Gongren Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Hebei North University

OTHER

Sponsor Role collaborator

Cangzhou People's Hospital

OTHER

Sponsor Role collaborator

Harrison International Peace Hospital

OTHER

Sponsor Role collaborator

Tsinghua University

OTHER

Sponsor Role lead

Responsible Party

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Xihai Zhao

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xihai Zhao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tsinghua University

Locations

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

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dongye Li, MD

Role: CONTACT

Phone: 1561153321

Email: [email protected]

Yongjun Han, MD

Role: CONTACT

Phone: 15116962341

Email: [email protected]

Facility Contacts

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Le He, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 24481975 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25628303 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24646875 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23444308 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18535283 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26437991 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25953365 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35058694 (View on PubMed)

Other Identifiers

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D171100003017003

Identifier Type: -

Identifier Source: org_study_id