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Completed

NCT Number: NCT02485275

Stroke Imaging Package Study

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.

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Key information

Conditions

Acute Ischemic Stroke Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Intracranial Arteriosclerosis Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Jishuitan Hospital, Beijing, Beijing Municipality, China

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About this study

  • 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.
  • 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).
  • The neurofunctional fluctuation during hospitalization as well as 90-day outcomes were carefully assessed. Patients were followed up for 90-days after stroke onset.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Wei-Hai Xu

Other

Collaborators

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

Registry information

Acronym: SIPS

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 30, 2015
Registry last updated
Dec 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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