Ignite Creation Date:
2024-05-06 @ 7:43 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02580097
Status:
COMPLETED
Last Update Posted:
2021-09-01
First Post:
2015-10-16
Brief Title:
MR-based Stroke Mechanism and Future Risk Score
Sponsor:
Chinese PLA General Hospital
Organization:
Chinese PLA General Hospital
Study Overview
Official Title:
MR-based Stroke Mechanism and Future Risk Score
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MR-STARS
Brief Summary:
To explore prediction model for outcome of patients with acute ischemic stroke using multimodal Magnetic ResonanceMR imaging was a multicenter prospective observational study supported by National Natural Science Foundation of China Imaging evaluation of hemodynamic status and antegrade flow were assessed Patients were followed up to record radiological and clinical outcome The study recruited patients from 11 centers located in 10 provinces or province-level municipalities across the northeast to the southeast of China mainland
Detailed Description:
Patients
Patients with cerebral ischemia sympton of onset in 24 hours were included Baseline materials NIH stroke scale score modified Rankin Scale at admission stroke causes time from sympton onset to enrollment were recorded
Imaging scan were conducted at admission within 7 days after admission
Imaging protocols
MRI scan protocols T2 weighted image T1 weighted image Diffusion weighted imageDWI fluid-attenuated inversion recoveryFLAIR Perfusion weighted imagePWI arterial spin labelingASL susceptibility-weighted imagingSWI
Contrast agent
Omniscan 2mlkg Inject rate3mls
Digital subtraction angiographyDSA protocols
Selective angiography and imaging phase from arterial phase to late venous phase
Imaging evaluation
Antegrade flow assessment from ASL Cerebral blood flowCBF map Collateral flow assessment from ASL CBF map ASL subtraction CBF map PWI postprocessing map FLAIR hyperintensity vascular sign
Initial infarct volume measurement form DWI Final infarct volume measurement from FLAIR DWI-ASPECTS Stroke lesions pattern assessment identified on DWI DSA antegrade and collateral grade using modified Thrombolysis in Cerebral InfarctionTICI scale and The American Society of Interventional and Therapeutic Neuroradiology ASITN collateral grading system
Treatment
Intravenous recombinant tissue plasminogen activatorrtPA endovascular therapy and conventional treatment including neuro protection ante-platelet and statin
Follow up
within Seven days and a month after imaging follow up and clinical stroke event and modified Rankin ScalemRS record in 1 year
Note
The original trial from 2015 to 2018 recruited patients with acute and subacute ischemic stroke and the trial plan was changed to recruit patients with acute cerebral ischemia sympton of onset within 24 hThe study has been upgraded from a single-center study to a multi-center study since 2018
Patients with cerebral ischemia sympton of onset in 24 hours were included Baseline materials NIH stroke scale score modified Rankin Scale at admission stroke causes time from sympton onset to enrollment were recorded
Imaging scan were conducted at admission within 7 days after admission
Imaging protocols
MRI scan protocols T2 weighted image T1 weighted image Diffusion weighted imageDWI fluid-attenuated inversion recoveryFLAIR Perfusion weighted imagePWI arterial spin labelingASL susceptibility-weighted imagingSWI
Contrast agent
Omniscan 2mlkg Inject rate3mls
Digital subtraction angiographyDSA protocols
Selective angiography and imaging phase from arterial phase to late venous phase
Imaging evaluation
Antegrade flow assessment from ASL Cerebral blood flowCBF map Collateral flow assessment from ASL CBF map ASL subtraction CBF map PWI postprocessing map FLAIR hyperintensity vascular sign
Initial infarct volume measurement form DWI Final infarct volume measurement from FLAIR DWI-ASPECTS Stroke lesions pattern assessment identified on DWI DSA antegrade and collateral grade using modified Thrombolysis in Cerebral InfarctionTICI scale and The American Society of Interventional and Therapeutic Neuroradiology ASITN collateral grading system
Treatment
Intravenous recombinant tissue plasminogen activatorrtPA endovascular therapy and conventional treatment including neuro protection ante-platelet and statin
Follow up
within Seven days and a month after imaging follow up and clinical stroke event and modified Rankin ScalemRS record in 1 year
Note
The original trial from 2015 to 2018 recruited patients with acute and subacute ischemic stroke and the trial plan was changed to recruit patients with acute cerebral ischemia sympton of onset within 24 hThe study has been upgraded from a single-center study to a multi-center study since 2018
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None