Hypoperfusion-hypodensity Mismatch for the Identification of Patients With Stroke Within 4.5 Hours

Acute Ischemic Stroke Clinical Trial

— MissPerfeCT  

Official title:

Mismatch Between Hypoperfusion and Hypodensity on CT for the Identification of Patients With Stroke Onset Within 4.5 Hours

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04277728
• Other study ID #: 100001
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Stroke

Intervention

Diagnostic Test:
• hypoperfusion-hypodensity mismatch
hypoperfusion-hypodensity mismatch on computed tomography

Locations

Country	Name	City	State
Germany	University Hospital Münster	Münster

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

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