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

NCT ID: NCT04277728

Last Updated: 2020-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

689 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Acute Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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hypoperfusion-hypodensity mismatch

hypoperfusion-hypodensity mismatch on computed tomography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Muenster

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jens Minnerup, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Muenster

Locations

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University Hospital Münster

Münster, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 38225983 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34649883 (View on PubMed)

Other Identifiers

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100001

Identifier Type: -

Identifier Source: org_study_id

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