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

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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

Tracking Information
First Submitted Date February 17, 2020
First Posted Date February 20, 2020
Last Update Posted Date February 20, 2020
Actual Study Start Date January 1, 2018
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 17, 2020)
  • Positive predictive value of "hypoperfusion hypodensity mismatch" for the identification of patients ≤4.5 hours [ Time Frame: on admission ]
  • Specificity of "hypoperfusion hypodensity mismatch" for the identification of patients ≤4.5 hours [ Time Frame: on admission ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Hypoperfusion-hypodensity Mismatch for the Identification of Patients With Stroke Within 4.5 Hours
Official Title Mismatch Between Hypoperfusion and Hypodensity on CT for the Identification of Patients With Stroke Onset Within 4.5 Hours
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with acute ischemic stroke and known time of symptom onset.
Condition Acute Ischemic Stroke
Intervention Diagnostic Test: hypoperfusion-hypodensity mismatch
hypoperfusion-hypodensity mismatch on computed tomography
Study Groups/Cohorts Not Provided
Publications * Sporns PB, Kemmling A, Minnerup H, Meyer L, Krogias C, Puetz V, Thierfelder K, Duering M, Kaiser D, Langner S, Massoth C, Brehm A, Rotkopf L, Kunz WG, Karch A, Fiehler J, Heindel W, Schramm P, Royl G, Wiendl H, Psychogios M, Minnerup J. CT Hypoperfusion-Hypodensity Mismatch to Identify Patients With Acute Ischemic Stroke Within 4.5 Hours of Symptom Onset. Neurology. 2021 Nov 23;97(21):e2088-e2095. doi: 10.1212/WNL.0000000000012891. Epub 2021 Oct 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 17, 2020)
689
Original Actual Enrollment Same as current
Actual Study Completion Date December 31, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT04277728
Other Study ID Numbers 100001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party University Hospital Muenster
Original Responsible Party Same as current
Current Study Sponsor University Hospital Muenster
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Jens Minnerup, MD University Hospital Muenster
PRS Account University Hospital Muenster
Verification Date February 2020