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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04277728
Recruitment Status : Completed
First Posted : February 20, 2020
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Muenster

Brief 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.

Condition or disease Intervention/treatment
Acute Ischemic Stroke Diagnostic Test: hypoperfusion-hypodensity mismatch

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Study Type : Observational
Actual Enrollment : 689 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Mismatch Between Hypoperfusion and Hypodensity on CT for the Identification of Patients With Stroke Onset Within 4.5 Hours
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

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


Primary Outcome Measures :
  1. Positive predictive value of "hypoperfusion hypodensity mismatch" for the identification of patients ≤4.5 hours [ Time Frame: on admission ]
  2. Specificity of "hypoperfusion hypodensity mismatch" for the identification of patients ≤4.5 hours [ Time Frame: on admission ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with acute ischemic stroke and known time of symptom onset.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04277728


Locations
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Germany
University Hospital Münster
Münster, Germany
Sponsors and Collaborators
University Hospital Muenster
Investigators
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Principal Investigator: Jens Minnerup, MD University Hospital Muenster
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT04277728    
Other Study ID Numbers: 100001
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases