Stroke Imaging Package Study (SIPS)

December 12, 2018 updated by: Wei-Hai Xu
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 Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

949

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital
      • Beijing, Beijing, China, 100038
        • Beijing Jishuitan Hospital
      • Beijing, Beijing, China, 100039
        • The Third Medical Center of Chinese PLA General Hospital
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Army Medical Center of PLA
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Third Affiliated Hospital of Sun Yat-sen University
    • Hebei
      • Tangshan, Hebei, China, 063000
        • Tangshan Gongren Hospital
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Renmin Hospital of Wuhan University
    • Hunan
      • Hengyang, Hunan, China, 421001
        • The First Affiliated Hospital of University of South China
    • Jiangsu
      • Yangzhou, Jiangsu, China, 225001
        • Subei People's Hospital of Jiangsu province
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
      • Changchun, Jilin, China, 130033
        • China-Japan Union Hospital of Jilin University
    • Liaoning
      • Shenyang, Liaoning, China, 110840
        • General Hospital of Northern Theater Command
    • Shandong
      • Qingdao, Shandong, China, 266555
        • Qilu Hospital of Shandong University
    • Shanghai
      • Shanghai, Shanghai, China, 200050
        • Tongren hospital, Shanghai Jiaotong University School of Medicine
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Second Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
early neurological deterioration within 3 weeks after stroke onset (END-3 weeks)
Time Frame: 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.
3 weeks after stroke onset
90-days prognosis
Time Frame: 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.
90-days after stroke onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wei-Hai Xu

Collaborators

Peking Union Medical College Hospital
Qilu Hospital of Shandong University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Shanghai Tong Ren Hospital
The First Hospital of Jilin University
Third Affiliated Hospital, Sun Yat-Sen University
Fujian Medical University Union Hospital
Renmin Hospital of Wuhan University
The First Affiliated Hospital of University of South China
Beijing Jishuitan Hospital
China-Japan Union Hospital, Jilin University
Subei People's Hospital of Jiangsu Province
Tangshan Gongren Hospital
The General Hospital of Northern Theater Command
The Third Medical Center of Chinese PLA General Hospital
Army Medical Center of PLA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

April 30, 2017

Study Completion (Actual)

November 30, 2017

Study Registration Dates

First Submitted

June 25, 2015

First Submitted That Met QC Criteria

June 29, 2015

First Posted (Estimate)

June 30, 2015

Study Record Updates

Last Update Posted (Actual)

December 14, 2018

Last Update Submitted That Met QC Criteria

December 12, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRMRI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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