Intracranial Artery Stenosis Magnetic Resonance Imaging: Aetiology and Progression

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.

Study Overview

• Status: Unknown
• Conditions: Ischemic Stroke; Transient Ischemic Attack; Intracranial Artery Stenosis

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100084
    • Recruiting
    • Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University
    • Contact: Le He, MD; Phone Number: 861062796175; Email: hele0806@aliyun.com
    • Principal Investigator: Xihai Zhao, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression of plaque burden	Maximum wall thickness	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression of luminal stenosis	Mild (<50%), moderate (50-70%), severe (70-99%), and occlusion	24 months
Progression of plaque components	Presence of intraplaque hemorrhage	24 months
cerebrovascular events	ischemic stroke or transient ischemia attack	24 months

Collaborators and Investigators

• Sponsor: Tsinghua University
• Collaborators: Beijing Tiantan Hospital; Xuanwu Hospital, Beijing; Beijing Hospital; Tianjin First Central Hospital; Hebei Medical University Third Hospital; 309th Hospital of Chinese People's Liberation Army; Navy General Hospital, Beijing; Tianjin Union Medical Center; First Hospitals affiliated to the China PLA General Hospital; Beijing Pinggu District Hospital; Beijing Huairou Hospital; Beijing Shuyi Hospital; Tianjin 4th Centre 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
• Investigators: Principal Investigator: Xihai Zhao, MD, PhD, Tsinghua University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2017
• Primary Completion (Anticipated): March 25, 2021
• Study Completion (Anticipated): March 25, 2022

Study Registration Dates

• First Submitted: January 24, 2018
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (Actual): January 31, 2018

Study Record Updates

• Last Update Posted (Actual): January 31, 2018
• Last Update Submitted That Met QC Criteria: January 24, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Atherosclerosis; Intracranial artery; Intracranial artery stenosis; High-Resolution Magnetic Resonance
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathological Conditions, Anatomical; Brain Ischemia; Stroke; Ischemic Stroke; Ischemia; Ischemic Attack, Transient; Constriction, Pathologic
• Other Study ID Numbers: D171100003017003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No