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

• ClinicalTrials.gov Identifier: NCT04277728
• Recruitment Status: Completed
• First Posted: February 20, 2020
• Last Update Posted: February 20, 2020
• Sponsor: University Hospital Muenster
• 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.

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

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