Improving Low ASPECTS Stroke Thrombectomy

Acute Ischemic Stroke Clinical Trial

— I-LAST  

Official title:

Improving Low Alberta Stroke Program Early ct Score Stroke Thrombectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04862507
• Other study ID #: I-LAST
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: January 1, 2028

Study information

• Verified date: May 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Gabriel Broocks, MD
• Phone: +4915222817182
• Email: g.broocks[@]uke.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 1, 2028
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke

Intervention

Other:
• Telephone call on day 90
telephone call on day 90 to assess the primary outcome (mRs 90)

Diagnostic Test:
• Quantification of lesion water uptake by CT densitometry
Retrospective quantification of lesion water uptake by CT densitometry in admission and follow-up imaging

Locations

Country	Name	City	State
Germany	Charite University Berlin	Berlin
Germany	Hospital Bremen-Mitte	Bremen
Germany	University Medical Center Hamburg-Eppendorf	Hamburg
Germany	Westpfalzklinikum	Kaiserslautern
Germany	University Hospital Marburg	Marburg
Germany	University Münster	Münster
Germany	University Rostock	Rostock
Switzerland	University Basel	Basel

Sponsors (7)

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

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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