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Intracranial Artery Stenosis Magnetic Resonance Imaging: Aetiology and Progression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03417063
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : January 31, 2018
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Xihai Zhao, Tsinghua University

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
Ischemic Stroke Transient Ischemic Attack Intracranial Artery Stenosis

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Progression of plaque burden [ Time Frame: 24 months ]
    Maximum wall thickness


Secondary Outcome Measures :
  1. Progression of luminal stenosis [ Time Frame: 24 months ]
    Mild (<50%), moderate (50-70%), severe (70-99%), and occlusion

  2. Progression of plaque components [ Time Frame: 24 months ]
    Presence of intraplaque hemorrhage

  3. cerebrovascular events [ Time Frame: 24 months ]
    ischemic stroke or transient ischemia attack



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Dongye Li, MD 1561153321 dongyeli1988@126.com
Contact: Yongjun Han, MD 15116962341 lalyn0322@hotmail.com

Locations
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China
Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University Recruiting
Beijing, China, 100084
Contact: Le He, MD    861062796175    hele0806@aliyun.com   
Principal Investigator: Xihai Zhao, MD, PhD         
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
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Principal Investigator: Xihai Zhao, MD, PhD Tsinghua University
Additional Information:

Publications:

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Responsible Party: Xihai Zhao, Professor, Tsinghua University
ClinicalTrials.gov Identifier: NCT03417063    
Other Study ID Numbers: D171100003017003
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xihai Zhao, Tsinghua University:
Intracranial artery
Atherosclerosis
Intracranial artery stenosis
High-Resolution Magnetic Resonance
Additional relevant MeSH terms:
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Ischemic Attack, Transient
Ischemia
Constriction, Pathologic
Pathologic Processes
Pathological Conditions, Anatomical
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases