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Completed

NCT Number: NCT04277728

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

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Münster

Münster, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hypoperfusion-hypodensity mismatch

Diagnostic Test

hypoperfusion-hypodensity mismatch on computed tomography

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Registry information

Official study title

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

Acronym: MissPerfeCT

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 20, 2020
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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