Improving Low ASPECTS Stroke Thrombectomy

NCT ID: NCT04862507

Last Updated: 2023-05-24

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

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2028-01-01

Brief Summary

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Improving Low ASPECTS Stroke Thromectomy (I-LAST) is an academic, independent, prospective, multicenter, observational registry study. Consecutive patients treated with endovascular stroke treatment will be enrolled in German stroke centers. Patients receive regular care and data will be collected as part of clinical routine. Baseline clinical and procedural information as well clinical follow-up information during in-hospital stay, and up to 90 days of stroke onset are collected. Data collected include demographics, National Institute of Health Stroke Scale (NIHSS) on admission, pre-treatment ASPECTS, information on timing and success of interventional treatment, procedural complications, intracranial hemorrhage, and functional outcome. Advanced imaging biomarkers will be tested and validated aiming to improve treatment selection and outcome prediction of patients presenting with extensive baseline infarction.

Detailed Description

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This study aims to investigate the role of advanced imaging biomarkers in patients with large early infarct, in particular quantitative lesion water uptake (Minnerup et al. Annals of Neurology 2016), arterial and venous collateral circulation (Faizy et al. Radiology 2021), and multivariate CTP-derived parameters (Kemmling et al. JCBFM 2015). The goal is to use these imaging biomarkers as specific selection criterion to predict clinical benefit after reperfusion despite extensive baseline infarct lesions, also as a method of monitoring adjuvant neuroprotective agents after reperfusion therapy (for instance anti-edematous medication).

Conditions

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Acute Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Stroke Patients with an ASPECTS of 0-5 on baseline neuroimaging undergoing thrombectomy

acute stroke patients treated with endovascular treatment combined with thrombolysis or without previous thrombolysis Intervention.

Telephone call on day 90

Intervention Type OTHER

telephone call on day 90 to assess the primary outcome (mRs 90)

Quantification of lesion water uptake by CT densitometry

Intervention Type DIAGNOSTIC_TEST

Retrospective quantification of lesion water uptake by CT densitometry in admission and follow-up imaging

Stroke Patients with an ASPECTS of 0-5 on baseline neuroimaging not undergoing thrombectomy

acute stroke patients treated with or without thrombolysis

Telephone call on day 90

Intervention Type OTHER

telephone call on day 90 to assess the primary outcome (mRs 90)

Quantification of lesion water uptake by CT densitometry

Intervention Type DIAGNOSTIC_TEST

Retrospective quantification of lesion water uptake by CT densitometry in admission and follow-up imaging

Interventions

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Telephone call on day 90

telephone call on day 90 to assess the primary outcome (mRs 90)

Intervention Type OTHER

Quantification of lesion water uptake by CT densitometry

Retrospective quantification of lesion water uptake by CT densitometry in admission and follow-up imaging

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of acute ischemic stroke
* ASPECTS of 0-5
* Confirmed diagnosis of persistent occlusion of terminal carotid artery, middle cerebral artery (M1 or M2), or basilar artery consistent with symptoms
* Age \>18 years
* Ethic approval in process

Exclusion Criteria

none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kaiserslautern

OTHER

Sponsor Role collaborator

University Hospital Muenster

OTHER

Sponsor Role collaborator

University of Rostock

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

Klinikum Bremen-Mitte, gGmbH

OTHER

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Gabriel Broocks

Assistant Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Charite University Berlin

Berlin, , Germany

Site Status ENROLLING_BY_INVITATION

Hospital Bremen-Mitte

Bremen, , Germany

Site Status ENROLLING_BY_INVITATION

University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status RECRUITING

Westpfalzklinikum

Kaiserslautern, , Germany

Site Status ENROLLING_BY_INVITATION

University Hospital Marburg

Marburg, , Germany

Site Status RECRUITING

University Münster

Münster, , Germany

Site Status ENROLLING_BY_INVITATION

University Rostock

Rostock, , Germany

Site Status ENROLLING_BY_INVITATION

University Basel

Basel, , Switzerland

Site Status ENROLLING_BY_INVITATION

Countries

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Germany Switzerland

Central Contacts

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Gabriel Broocks, MD

Role: CONTACT

+4915222817182

Andre Kemmling, MD, MHBA

Role: CONTACT

Facility Contacts

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Gabriel Broocks, MD

Role: primary

Andre Kemmling, MD

Role: primary

References

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Broocks G, Meyer L, Elsayed S, McDonough R, Bechstein M, Faizy TD, Sporns P, Schon G, Minnerup J, Kniep HC, Hanning U, Barow E, Schramm P, Langner S, Nawabi J, Papanagiotou P, Wintermark M, Lansberg MG, Albers GW, Heit JJ, Fiehler J, Kemmling A; I-LAST Investigators. Association Between Net Water Uptake and Functional Outcome in Patients With Low ASPECTS Brain Lesions: Results From the I-LAST Study. Neurology. 2023 Feb 28;100(9):e954-e963. doi: 10.1212/WNL.0000000000201601. Epub 2022 Nov 22.

Reference Type DERIVED
PMID: 36414425 (View on PubMed)

Other Identifiers

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I-LAST

Identifier Type: -

Identifier Source: org_study_id

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