Acute Ischemic Stroke Clinical Trial
— MissPerfeCTOfficial title:
Mismatch Between Hypoperfusion and Hypodensity on CT for the Identification of Patients With Stroke Onset Within 4.5 Hours
NCT number | NCT04277728 |
Other study ID # | 100001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2018 |
Est. completion date | December 31, 2019 |
Verified date | February 2020 |
Source | University Hospital Muenster |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Intravenous thrombolysis is recommended within 4.5 hours of stroke onset. The aim of the study is to evaluate whether a hypodensity on native CT within the virtually entire area of hypoperfusion on perfusion CT, i.e. hypoperfusion-hypodensity mismatch, identifies patients within the time window of thrombolysis in a multicenter cohort. The investigators hypothesize hypoperfusion-hypodensity mismatch will identify patients ≤ 4,5 hours of symptom onset with >70% specificity and >85% positive predictive value.
Status | Completed |
Enrollment | 689 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - acute ischemic stroke - evidence of acute intracranial vessel occlusion (any supratentorial proximal or peripheral artery of the anterior cerebral artery, middle cerebral artery or posterior cerebral artery territory) by CT hyper dense thrombus and/or CTangiography vessel occlusion and/or by ischemic perfusion deficit - evidence for acute ischemic perfusion deficit, i.e. acute symptoms attributable to ischemic CT perfusion lesion - complete native CT and CTperfusion performed on admission - sufficient CT and CTperfusion quality for judgement of acute ischemic hypodensity - known time of symptom onset. Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Münster | Münster |
Lead Sponsor | Collaborator |
---|---|
University Hospital Muenster |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Positive predictive value of "hypoperfusion hypodensity mismatch" for the identification of patients =4.5 hours | on admission | ||
Primary | Specificity of "hypoperfusion hypodensity mismatch" for the identification of patients =4.5 hours | on admission |
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