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Intracranial Artery Stenosis Magnetic Resonance Imaging: Aetiology and Progression

Sponsor
Tsinghua University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03417063
Collaborator
Xuanwu Hospital, Beijing (Other), Beijing Tiantan Hospital (Other), Beijing Hospital (Other), 309th Hospital of Chinese People's Liberation Army (Other), Navy General Hospital, Beijing (Other), First Hospitals affiliated to the China PLA General Hospital (Other), Beijing Huairou Hospital (Other), Beijing Pinggu District Hospital (Other), Beijing Shuyi Hospital (Other), Tianjin First Central Hospital (Other), Tianjin 4th Centre Hospital (Other), Tianjin Union Medical Center (Other), Hebei Medical University Third Hospital (Other), Affiliated Hospital of Chengde Medical University (Other), Tangshan Gongren Hospital (Other), The First Affiliated Hospital of Hebei North University (Other), Cangzhou People's Hospital (Other), Harrison International Peace Hospital (Other)
300
Enrollment
1
Location
53.3
Anticipated Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Intracranial Artery Stenosis Magnetic Resonance Imaging: Aetiology and Progression (ICASMAP)
    Actual Study Start Date :
    Oct 14, 2017
    Anticipated Primary Completion Date :
    Mar 25, 2021
    Anticipated Study Completion Date :
    Mar 25, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Progression of plaque burden [24 months]

      Maximum wall thickness

    Secondary Outcome Measures

    1. Progression of luminal stenosis [24 months]

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

    2. Progression of plaque components [24 months]

      Presence of intraplaque hemorrhage

    3. cerebrovascular events [24 months]

      ischemic stroke or transient ischemia attack

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University Beijing China 100084

    Sponsors and Collaborators

    • Tsinghua University
    • Xuanwu Hospital, Beijing
    • Beijing Tiantan Hospital
    • Beijing Hospital
    • 309th Hospital of Chinese People's Liberation Army
    • Navy General Hospital, Beijing
    • First Hospitals affiliated to the China PLA General Hospital
    • Beijing Huairou Hospital
    • Beijing Pinggu District Hospital
    • Beijing Shuyi Hospital
    • Tianjin First Central Hospital
    • Tianjin 4th Centre Hospital
    • Tianjin Union Medical Center
    • Hebei Medical University Third 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Xihai Zhao, Professor, Tsinghua University
    ClinicalTrials.gov Identifier:
    NCT03417063
    Other Study ID Numbers:
    • D171100003017003
    First Posted:
    Jan 31, 2018
    Last Update Posted:
    Jan 31, 2018
    Last Verified:
    Jan 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xihai Zhao, Professor, Tsinghua University
    Intracranial artery
    Atherosclerosis
    Intracranial artery stenosis
    High-Resolution Magnetic Resonance
    Additional relevant MeSH terms:
    Ischemic Stroke
    Ischemic Attack, Transient
    Ischemia
    Constriction, Pathologic

    Study Results

    No Results Posted as of Jan 31, 2018