NCT03367286 Comparison Influence to Prognosis of CTP and MRP in AIS Patients
| NCT ID | NCT03367286 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Stroke |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2009-06-30 |
| Primary Completion | 2024-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2009-06-30 with a primary completion date of 2024-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Criteria: Inclusion Criteria: 1. Provision of informed consent; 2. Male and female adults aged 18-80 years old; 3. 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. Exclusion Criteria: 1. Standard contraindications to rt-PA; 2. Contraindication to imaging with contrast agents; 3. Pre-stroke mRS score of ≥2 (indicating previous disability); 4. Participation in any investigational study in the previous 30 days; 5. Any terminal illness such that patient would not be expected to survive more than one-year.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03367286 clinical trial?
This trial is open to participants of all sexes, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03367286 currently recruiting?
Yes, NCT03367286 is actively recruiting participants. Contact the research team at loumingxc@vip.sina.com for enrollment information.
Where is the NCT03367286 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT03367286 clinical trial?
NCT03367286 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 1,000 participants.
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