Improving Low ASPECTS Stroke Thrombectomy (I-LAST)

Improving Low Alberta Stroke Program Early ct Score Stroke Thrombectomy

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Other: Telephone call on day 90; Diagnostic test: Quantification of lesion water uptake by CT densitometry

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Gabriel Broocks, MD; Phone Number: +4915222817182; Email: g.broocks@uke.de
• Study Contact Backup: Name: Andre Kemmling, MD, MHBA; Email: akemmling@gmail.com

Study Locations

• Germany
  • Berlin, Germany
    • Enrolling by invitation
    • Charite University Berlin
  • Bremen, Germany
    • Enrolling by invitation
    • Hospital Bremen-Mitte
  • Hamburg, Germany, 20251
    • Recruiting
    • University Medical Center Hamburg-Eppendorf
    • Contact: Gabriel Broocks, MD
  • Kaiserslautern, Germany
    • Enrolling by invitation
    • Westpfalzklinikum
  • Marburg, Germany
    • Recruiting
    • University Hospital Marburg
    • Contact: Andre Kemmling, MD
  • Münster, Germany
    • Enrolling by invitation
    • University Münster
  • Rostock, Germany
    • Enrolling by invitation
    • University Rostock
• Switzerland
  • Basel, Switzerland
    • Enrolling by invitation
    • University Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All acute stroke patients with the clinical diagnosis of acute ischemic stroke with a ASPECTS 0f 0-5 on baseline imaging; Age >18 years

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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
Stroke Patients with an ASPECTS of 0-5 on baseline neuroimaging not undergoing thrombectomy; acute stroke patients treated with or without thrombolysis	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Charite University, Berlin, Germany; University Hospital Muenster; University Hospital, Basel, Switzerland; University of Rostock; Klinikum Bremen-Mitte, gGmbH; University of Kaiserslautern

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Anticipated): January 1, 2027
• Study Completion (Anticipated): January 1, 2028

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: I-LAST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be shared upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No