Clinical trial NCT03417063: Intracranial Artery Stenosis Magnetic Resonance Imaging: Aetiology and Progression
Official title: Intracranial Artery Stenosis Magnetic Resonance Imaging: Aetiology and Progression (ICASMAP)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Transient Ischemic Attack
Intracranial Artery Stenosis
Keywords: Intracranial artery
Atherosclerosis
Intracranial artery stenosis
High-Resolution Magnetic Resonance
Lead sponsor: Tsinghua University
Sponsor class: OTHER
Collaborators: name: Xuanwu Hospital, Beijing
name: Beijing Tiantan Hospital
name: Beijing Hospital
name: 309th Hospital of Chinese People's Liberation Army
name: Navy General Hospital, Beijing
name: First Hospitals affiliated to the China PLA General Hospital
name: Beijing Huairou Hospital
name: Beijing Pinggu District Hospital
name: Beijing Shuyi Hospital
name: Tianjin First Central Hospital
name: Tianjin 4th Centre Hospital
name: Tianjin Union Medical Center
name: Hebei Medical University Third Hospital
name: Affiliated Hospital of Chengde Medical University
name: Tangshan Gongren Hospital
name: The First Affiliated Hospital of Hebei North University
name: Cangzhou People's Hospital
name: Harrison International Peace Hospital
First posted: 2018-01-31
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression of plaque burden
timeFrame: 24 months
Secondary outcomes:
measure: Progression of luminal stenosis
timeFrame: 24 months
measure: Progression of plaque components
timeFrame: 24 months
measure: cerebrovascular events
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University
Study officials:
affiliation: Tsinghua University
name: Xihai Zhao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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