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Intracranial Artery Stenosis Magnetic Resonance Imaging: Aetiology and Progression

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03417063
Enrollment
300
Registered
2018-01-31
Start date
2017-10-14
Completion date
2022-03-25
Last updated
2018-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Artery Stenosis, Ischemic Stroke, Transient Ischemic Attack

Keywords

Intracranial artery, Atherosclerosis, Intracranial artery stenosis, High-Resolution Magnetic Resonance

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Progression of plaque burden24 monthsMaximum wall thickness

Secondary

MeasureTime frameDescription
Progression of luminal stenosis24 monthsMild (\<50%), moderate (50-70%), severe (70-99%), and occlusion
Progression of plaque components24 monthsPresence of intraplaque hemorrhage
cerebrovascular events24 monthsischemic stroke or transient ischemia attack

Countries

China

Contacts

Primary ContactDongye Li, MD
dongyeli1988@126.com1561153321
Backup ContactYongjun Han, MD
lalyn0322@hotmail.com15116962341

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026