Skip to content

Stroke Imaging Package Study

Stroke Imaging Package Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02485275
Acronym
SIPS
Enrollment
949
Registered
2015-06-30
Start date
2015-07-01
Completion date
2017-11-30
Last updated
2018-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke, Cerebral Small Vessel Diseases, Intracranial Arteriosclerosis

Keywords

AIS, ICAS, CSVD

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
early neurological deterioration within 3 weeks after stroke onset (END-3 weeks)3 weeks after stroke onsetEND-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.
90-days prognosis90-days after stroke onset90-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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026