Comparison Influence to Prognosis of CTP and MRP in AIS Patients
1 other identifier
observational
1,000
1 country
1
Brief Summary
Acute ischemia stroke (AIS) is the leading cause of death in China. Thrombolytic therapy with recombinant tissue plasminogen activator (rt-PA) has been proven to reduce disability in AIS patients within 4.5 hours after symptom onset. However, only 2% of AIS patients received thrombolytic therapy in China. Perfusion imaging is demonstrated to increase the rate of thrombolytic therapy by identifying the ischemic infarct core (the brain tissue that is irreversibly injured) and the ischemia penumbra (the brain tissue surrounding the ischemia infarct core that is hypoperfused but still viable) for those patients with extending therapeutic window (beyond the current 4.5 hours after symptom onset), as well as minor stroke or those with atypical symptoms. Three prospective clinical trials, DEFUSE, DEFUSE-2 and EPITHET, has confirmed that mismatch between perfusion weighted-imaging (PWI) and diffusion weighted-imaging (DWI) correspond to the ischemic penumbra whereas DWI provides information of the ischemia infarct core and major reperfusion relate to good clinical outcome in extending therapeutic window AIS patients with DWI-PWI mismatch. Computed tomography perfusion (CTP) may be a potential alternative technology for recognition of reversibly damaged brain tissue in AIS patients, with the prominent advantage of fast scan. Recent studies also demonstrated that CTP could select eligible candidates for reperfusion therapy. More recently, with data of EXTEND-IA, reperfusion therapy in AIS patients with CTP mismatch (using a CT time to maximum \>6 s as ischemic hypoperfusion volume and a CT relative cerebral blood flow \<30% of that in normal tissue as ischemic core volume) were related to good clinical outcome. However, plenty of studies demonstrated CT cerebral blood volume did not always predict ischemic infarct core in AIS patients. A recent study also confirmed the poor contrast: noise ratios of CT cerebral blood volume and CT cerebral blood flow result in large measurement error, compared with those of diffusion weighted imaging (DWI), making it problematic to substitute DWI in selecting individual AIS patients for reperfusion treatment. Based on those studies, it is still remained unclear whether CTP can be an alternative choice to replace magnetic resonance perfusion (MRP) in AIS patients with extending therapeutic windows. So in this study, the investigators try to determine whether baseline CTP profiles have a comparable ability to MRP in identifying patients who have a robust clinical response after early reperfusion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 30, 2009
CompletedFirst Submitted
Initial submission to the registry
October 5, 2017
CompletedFirst Posted
Study publicly available on registry
December 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
ExpectedNovember 23, 2022
November 1, 2022
15 years
October 5, 2017
November 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
modified Rankin Scale at 90 days
modified Rankin Scale at 90 days
90 days
Study Arms (2)
Computed Tomography Perfusion (CTP)
Magnetic Resonance Perfusion (MRP)
Interventions
different inspection modes：Computed Tomography Perfusion (CTP) or Magnetic Resonance Perfusion (MRP)
Eligibility Criteria
acute ischemic stroke patients
You may qualify if:
- Provision of informed consent;
- Male and female adults aged 18-80 years old;
- For patients accepting CTP or MRP over 4.5 hours after stroke onset, imaging criteria: infarct core volume \<70mL, perfusion leison volume / infarct core volume \>1.2, and absolute mismatch \>10 mL.
You may not qualify if:
- Standard contraindications to rt-PA;
- Contraindication to imaging with contrast agents;
- Pre-stroke mRS score of ≥2 (indicating previous disability);
- Participation in any investigational study in the previous 30 days;
- Any terminal illness such that patient would not be expected to survive more than one-year.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The second affiliated hospital of Zhejiang University
Hangzhou, 310000, China
Related Publications (2)
Zhou Y, He Y, Yan S, Chen L, Zhang R, Xu J, Hu H, Liebeskind DS, Lou M. Reperfusion Injury Is Associated With Poor Outcome in Patients With Recanalization After Thrombectomy. Stroke. 2023 Jan;54(1):96-104. doi: 10.1161/STROKEAHA.122.039337. Epub 2022 Nov 11.
PMID: 36367100DERIVEDYan S, Zhang X, Zhang R, Xu J, Lou M. Early Fibrinogen Depletion and Symptomatic Intracranial Hemorrhage After Reperfusion Therapy. Stroke. 2019 Oct;50(10):2716-2721. doi: 10.1161/STROKEAHA.119.025711. Epub 2019 Aug 9.
PMID: 31394994DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2017
First Posted
December 8, 2017
Study Start
June 30, 2009
Primary Completion
June 30, 2024
Study Completion (Estimated)
December 30, 2026
Last Updated
November 23, 2022
Record last verified: 2022-11