Improving Low ASPECTS Stroke Thrombectomy

Recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Other: Telephone call on day 90; Diagnostic Test: Quantification of lesion water uptake by CT densitometry

• Registration Number: NCT04862507
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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).

Study Timeline

• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-22
• Study First Posted: 2021-04-28
• Status Verified: 2023-05
• Study Start: 2023-05-01
• Last Update Submitted: 2023-05-23
• Last Update Posted: 2023-05-24
• Primary Completion: 2027-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stroke Patients with an ASPECTS of 0-5 on baseline neuroimaging undergoing thrombectomy	Telephone call on day 90	acute stroke patients treated with endovascular treatment combined with thrombolysis or without previous thrombolysis Intervention.
Stroke Patients with an ASPECTS of 0-5 on baseline neuroimaging not undergoing thrombectomy	Quantification of lesion water uptake by CT densitometry	acute stroke patients treated with or without thrombolysis
Stroke Patients with an ASPECTS of 0-5 on baseline neuroimaging undergoing thrombectomy	Quantification of lesion water uptake by CT densitometry	acute stroke patients treated with endovascular treatment combined with thrombolysis or without previous thrombolysis Intervention.
Stroke Patients with an ASPECTS of 0-5 on baseline neuroimaging not undergoing thrombectomy	Telephone call on day 90	acute stroke patients treated with or without thrombolysis

Primary Outcome Measures

Name	Time	Method
modified ranking scale on day (mRs) day 90	90 days	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.

Secondary Outcome Measures

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

Trial Locations

Locations (8)

University Basel; 🇨🇭 Basel, Switzerland

University Hospital Marburg; 🇩🇪 Marburg, Germany

Charite University Berlin; 🇩🇪 Berlin, Germany

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Westpfalzklinikum; 🇩🇪 Kaiserslautern, Germany

University Münster; 🇩🇪 Münster, Germany

Hospital Bremen-Mitte; 🇩🇪 Bremen, Germany

University Rostock; 🇩🇪 Rostock, Germany