Clinical trial NCT04862507: Improving Low ASPECTS Stroke Thrombectomy
Official title: Improving Low Alberta Stroke Program Early ct Score Stroke Thrombectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Ischemic Stroke
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: University of Kaiserslautern
name: University Hospital Muenster
name: University of Rostock
name: University Hospital, Basel, Switzerland
name: Charite University, Berlin, Germany
name: Klinikum Bremen-Mitte, gGmbH
First posted: 2021-04-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

Eligibility criteria: 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

Primary outcomes:
measure: modified ranking scale on day (mRs) day 90
timeFrame: 90 days
Secondary outcomes:
measure: Ischemic lesion water uptake on admission
timeFrame: 0-24 hours after symptom onset
measure: Ischemic lesion water uptake on follow-up imaging
timeFrame: 24-48 hours after admission
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University Berlin
city: Bremen
country: Germany
facility: Hospital Bremen-Mitte
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
city: Kaiserslautern
country: Germany
facility: Westpfalzklinikum
city: Marburg
country: Germany
facility: University Hospital Marburg
city: Münster
country: Germany
facility: University Münster
city: Rostock
country: Germany
facility: University Rostock
city: Basel
country: Switzerland
facility: University Basel
Study officials:
References: