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Stroke Imaging Package Study (SIPS)

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ClinicalTrials.gov Identifier: NCT02485275
Recruitment Status : Completed
First Posted : June 30, 2015
Last Update Posted : December 14, 2018
Sponsor:
Collaborators:
Peking Union Medical College Hospital
The Third Medical Center of Chinese PLA General Hospital
Army Medical Center of PLA
General Hospital of Northern Theater Command
Subei People's Hospital of Jiangsu Province
Second Affiliated Hospital, School of Medicine, Zhejiang University
Beijing Jishuitan Hospital
Fujian Medical University Union Hospital
First Hospital of Jilin University
The First Affiliated Hospital of University of South China
Qilu Hospital of Shandong University
Tangshan Gongren Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Renmin Hospital of Wuhan University
China-Japan Union Hospital, Jilin University
Shanghai Tong Ren Hospital
Information provided by (Responsible Party):
Wei-Hai Xu, Peking Union Medical College Hospital

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.

Condition or disease
Acute Ischemic Stroke Intracranial Arteriosclerosis Cerebral Small Vessel Diseases

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 949 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Stroke Imaging Package Study
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485275


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

Additional Information:

Publications:

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Responsible Party: Wei-Hai Xu, Associate Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02485275     History of Changes
Other Study ID Numbers: HRMRI
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
Keywords provided by Wei-Hai Xu, Peking Union Medical College Hospital:
AIS
ICAS
CSVD
Additional relevant MeSH terms:
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Stroke
Cerebral Small Vessel Diseases
Intracranial Arteriosclerosis
Arteriosclerosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Intracranial Arterial Diseases