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Improving Low ASPECTS Stroke Thrombectomy

Improving Low Alberta Stroke Program Early ct Score Stroke Thrombectomy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04862507
Acronym
I-LAST
Enrollment
500
Registered
2021-04-28
Start date
2023-05-01
Completion date
2028-01-01
Last updated
2023-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Brief summary

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

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).

Interventions

OTHERTelephone call on day 90

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

DIAGNOSTIC_TESTQuantification of lesion water uptake by CT densitometry

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

Sponsors

University of Kaiserslautern
CollaboratorOTHER
University Hospital Muenster
CollaboratorOTHER
University of Rostock
CollaboratorOTHER
University Hospital, Basel, Switzerland
CollaboratorOTHER
Charite University, Berlin, Germany
CollaboratorOTHER
Klinikum Bremen-Mitte, gGmbH
CollaboratorOTHER
Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
modified ranking scale on day (mRs) day 9090 daysmRs: modified ranking scale; the scale is a commonly used measurement for the degree of disability or dependence in the daily activities of people who have suffered a stroke; scale range 0-6, with 0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms. 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead. publication: van Swieten J, Koudstaal P, Visser M, Schouten H, et al. (1988). Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 19 (5): 604-607. doi:10.1161/01.str.19.5.604.

Secondary

MeasureTime frameDescription
Ischemic lesion water uptake on admission0-24 hours after symptom onsetIschemic lesion water uptake is a CT based quantitative imaging biomarker to assess ischemic edema based on densitometry
Ischemic lesion water uptake on follow-up imaging24-48 hours after admissionIschemic lesion water uptake is a CT based quantitative imaging biomarker to assess ischemic edema based on densitometry

Countries

Germany, Switzerland

Contacts

Primary ContactGabriel Broocks, MD
g.broocks@uke.de+4915222817182
Backup ContactAndre Kemmling, MD, MHBA
akemmling@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026