Improving Low ASPECTS Stroke Thrombectomy

Study Overview
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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).

Official Title
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Improving Low Alberta Stroke Program Early ct Score Stroke Thrombectomy

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Other: Telephone call on day 90
* Diagnostic Test: Quantification of lesion water uptake by CT densitometry


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stroke Patients with an ASPECTS of 0-5 on baseline neuroimaging undergoing thrombectomy<br>acute stroke patients treated with endovascular treatment combined with thrombolysis or without previous thrombolysis Intervention. | Other: Telephone call on day 90<br>* telephone call on day 90 to assess the primary outcome (mRs 90)<br>Diagnostic Test: Quantification of lesion water uptake by CT densitometry<br>* Retrospective quantification of lesion water uptake by CT densitometry in admission and follow-up imaging<br>|
| Stroke Patients with an ASPECTS of 0-5 on baseline neuroimaging not undergoing thrombectomy<br>acute stroke patients treated with or without thrombolysis | Other: Telephone call on day 90<br>* telephone call on day 90 to assess the primary outcome (mRs 90)<br>Diagnostic Test: Quantification of lesion water uptake by CT densitometry<br>* Retrospective quantification of lesion water uptake by CT densitometry in admission and follow-up imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified ranking scale on day (mRs) day 90 | mRs: 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. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemic lesion water uptake on admission | Ischemic lesion water uptake is a CT based quantitative imaging biomarker to assess ischemic edema based on densitometry | 0-24 hours after symptom onset | 
| Ischemic lesion water uptake on follow-up imaging | Ischemic lesion water uptake is a CT based quantitative imaging biomarker to assess ischemic edema based on densitometry | 24-48 hours after admission |