Intracranial Artery Stenosis Magnetic Resonance Imaging: Aetiology and Progression
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|ClinicalTrials.gov Identifier: NCT03417063|
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : January 31, 2018
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.
|Condition or disease|
|Ischemic Stroke Transient Ischemic Attack Intracranial Artery Stenosis|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||300 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Intracranial Artery Stenosis Magnetic Resonance Imaging: Aetiology and Progression (ICASMAP)|
|Actual Study Start Date :||October 14, 2017|
|Estimated Primary Completion Date :||March 25, 2021|
|Estimated Study Completion Date :||March 25, 2022|
- Progression of plaque burden [ Time Frame: 24 months ]Maximum wall thickness
- Progression of luminal stenosis [ Time Frame: 24 months ]Mild (<50%), moderate (50-70%), severe (70-99%), and occlusion
- Progression of plaque components [ Time Frame: 24 months ]Presence of intraplaque hemorrhage
- cerebrovascular events [ Time Frame: 24 months ]ischemic stroke or transient ischemia attack
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417063
|Contact: Dongye Li, MDfirstname.lastname@example.org|
|Contact: Yongjun Han, MDemail@example.com|
|Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University||Recruiting|
|Beijing, China, 100084|
|Contact: Le He, MD 861062796175 firstname.lastname@example.org|
|Principal Investigator: Xihai Zhao, MD, PhD|
|Principal Investigator:||Xihai Zhao, MD, PhD||Tsinghua University|