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

NCT04277728 | Completed

• 1 other identifier: 100001
• Study Type: observational
• Target: 689
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• Positive predictive value of "hypoperfusion hypodensity mismatch" for the identification of patients ≤4.5 hours

  on admission

• Specificity of "hypoperfusion hypodensity mismatch" for the identification of patients ≤4.5 hours

  on admission

Interventions

hypoperfusion-hypodensity mismatch DIAGNOSTIC_TEST

hypoperfusion-hypodensity mismatch on computed tomography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with acute ischemic stroke and known time of symptom onset.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

University Hospital Münster

Münster, Germany

Location

Related Publications (2)

• Sporns PB, Kemmling A, Meyer L, Krogias C, Puetz V, Thierfelder KM, Duering M, Lukas C, Kaiser D, Langner S, Brehm A, Rotkopf LT, Kunz WG, Beuker C, Heindel W, Fiehler J, Schramm P, Wiendl H, Minnerup H, Psychogios MN, Minnerup J. Computed tomography hypoperfusion-hypodensity mismatch vs. automated perfusion mismatch to identify stroke patients eligible for thrombolysis. Front Neurol. 2023 Dec 29;14:1320620. doi: 10.3389/fneur.2023.1320620. eCollection 2023.

  PMID: 38225983 DERIVED

• 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.

  PMID: 34649883 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jens Minnerup, MD

  University Hospital Muenster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 20, 2020
• Study Start: January 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 20, 2020

Record last verified: 2020-02

Locations

DE (1)