Intracranial Artery Stenosis Magnetic Resonance Imaging: Aetiology and Progression

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03417063
• Other study ID #: D171100003017003
• Status: Recruiting
• Phase: N/A
• First received: January 24, 2018
• Last updated: January 24, 2018
• Start date: October 14, 2017
• Est. completion date: March 25, 2022

Study information

• Verified date: January 2018
• Source: Tsinghua University
• Contact: Dongye Li, MD
• Phone: 1561153321
• Email: dongyeli1988[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 25, 2022
• Est. primary completion date: March 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Intracranial Artery Stenosis
• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Transient Ischemic Attack

Locations

Country	Name	City	State
China	Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University	Beijing

Sponsors (19)

Lead Sponsor

Collaborator

Tsinghua University

309th Hospital of Chinese People's Liberation Army, Affiliated Hospital of Chengde Medical University, Beijing Hospital, Beijing Huairou Hospital, Beijing Pinggu District Hospital, Beijing Shuyi Hospital, Beijing Tiantan Hospital, Cangzhou People's Hospital, First Hospitals affiliated to the China PLA General Hospital, Harrison International Peace Hospital, Hebei Medical University Third Hospital, Navy General Hospital, Beijing, Tangshan Gongren Hospital, The First Affiliated Hospital of Hebei North University, Tianjin 4th Centre Hospital, Tianjin First Central Hospital, Tianjin Union Medical Center, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of plaque burden	Maximum wall thickness	24 months
Secondary	Progression of luminal stenosis	Mild (<50%), moderate (50-70%), severe (70-99%), and occlusion	24 months
Secondary	Progression of plaque components	Presence of intraplaque hemorrhage	24 months
Secondary	cerebrovascular events	ischemic stroke or transient ischemia attack	24 months