Clinical trial NCT02485275: Stroke Imaging Package Study
Official title: Stroke Imaging Package Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Intracranial Arteriosclerosis
Cerebral Small Vessel Diseases
Keywords: AIS
ICAS
CSVD
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: The Third Medical Center of Chinese PLA General Hospital
name: Army Medical Center of PLA
name: The General Hospital of Northern Theater Command
name: Subei People's Hospital of Jiangsu Province
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Beijing Jishuitan Hospital
name: Fujian Medical University Union Hospital
name: The First Hospital of Jilin University
name: The First Affiliated Hospital of University of South China
name: Qilu Hospital of Shandong University
name: Tangshan Gongren Hospital
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Renmin Hospital of Wuhan University
name: China-Japan Union Hospital, Jilin University
name: Shanghai Tong Ren Hospital
First posted: 2015-06-30
Enrollment: 949
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from the collaborative stroke centers and will be followed for the duration of their hospitalization. Patients will be followed up until at least 3 months after stroke onset.

Brief summary: Our study aims to explore the value of new imaging technique package in predicting early neurological deterioration (END) as well as 90-day unfavorable outcome in patients with acute ischaemic stroke.

Detailed description: 1. Patients with acute ischemic stroke within 4.5-72h after onset were prospectively enrolled in our study and underwent standardized clinical and new imaging technique package assessment.
2. New imaging technique package mainly includes conventional cranial MRI （T1,T2,T2 FLAIR,DWI, and ADC), cranial magnetic resonance angiography (MRA), and intracranial vessel wall imaging (High-Resolution Magnetic Resonance Imaging,HRMRI) as well as susceptibility weighted imaging (SWI).
3. The neurofunctional fluctuation during hospitalization as well as 90-day outcomes were carefully assessed. Patients were followed up for 90-days after stroke onset.
4. Our study aims to explore the value of new imaging technique package in predicting early neurological deterioration (END) as well as 90-day unfavorable outcome in patients with acute ischaemic stroke.

Eligibility criteria: Inclusion Criteria:

1. patients with ischemic stroke and hospitalized during 4.5-72 hours after onset , confirmed by diffusion weighted imaging (DWI).
2. patients with stable vital signs.
3. patients who have underwent thrombolytic/intravascular therapy are allowed to enroll in the study.

Exclusion Criteria:

1. patients with absolute/relative contraindication to MRI (including but not confined to metal in the body and claustrophobia).
2. patients who is extremely agitated, and cannot comply with MRI exam.
3. patients who declined the consent.

Primary outcomes:
measure: early neurological deterioration within 3 weeks after stroke onset (END-3 weeks)
timeFrame: 3 weeks after stroke onset
measure: 90-days prognosis
timeFrame: 90-days after stroke onset
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
state: Beijing
city: Beijing
country: China
facility: The Third Medical Center of Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Chongqing
country: China
facility: Army Medical Center of PLA
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
city: Tangshan
country: China
facility: Tangshan Gongren Hospital
state: Hebei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Hengyang
country: China
facility: The First Affiliated Hospital of University of South China
state: Hunan
city: Yangzhou
country: China
facility: Subei People's Hospital of Jiangsu Province
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: China-Japan Union Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
city: Qingdao
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: Tongren Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
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citation: Li M, Wu SW, Xu WH. High-resolution MRI of radiation-induced intracranial vasculopathy. Neurology. 2015 Feb 10;84(6):631. doi: 10.1212/WNL.0000000000001223. No abstract available.