Stroke Imaging Package Study

Completed

• Conditions: Acute Ischemic Stroke; Cerebral Small Vessel Diseases; Intracranial Arteriosclerosis

• Registration Number: NCT02485275
• Lead Sponsor: Wei-Hai Xu

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.

Study Timeline

• Study First Submitted: 2015-06-25
• Study First Submitted QC: 2015-06-29
• Study First Posted: 2015-06-30
• Study Start: 2015-07-01
• Primary Completion: 2017-04-30
• Study Completion: 2017-11-30
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-12
• Last Update Posted: 2018-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 949

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
90-days prognosis	90-days after stroke onset	90-days prognosis included two parts :1) stroke recurrence with new lesion on DWI;2) the modified Ranking Score (mRS) at 90-days after stroke onset.
early neurological deterioration within 3 weeks after stroke onset (END-3 weeks)	3 weeks after stroke onset	END-3 weeks is defined as a significant neuro-functional decline \[increment of the National Institutes of Health Stroke Scale (NIHSS) ≥ 2 points \] within 3 weeks after admission.

Trial Locations

Locations (16)

Tangshan Gongren Hospital; 🇨🇳 Tangshan, Hebei, China

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China

The First Affiliated Hospital of University of South China; 🇨🇳 Hengyang, Hunan, China

Subei People's Hospital of Jiangsu Province; 🇨🇳 Yangzhou, Jiangsu, China

The First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

China-Japan Union Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

Qilu Hospital of Shandong University; 🇨🇳 Qingdao, Shandong, China

Tongren Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Second Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

Beijing Jishuitan Hospital; 🇨🇳 Beijing, Beijing, China

The Third Medical Center of Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Army Medical Center of PLA; 🇨🇳 Chongqing, Chongqing, China

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China

Third Affiliated Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China

General Hospital of Northern Theater Command; 🇨🇳 Shenyang, Liaoning, China