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NCT Number: NCT04862507

Improving Low ASPECTS 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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charite University Berlin, Berlin, Germany

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telephone call on day 90

Other

telephone call on day 90 to assess the primary outcome (mRs 90)

Quantification of lesion water uptake by CT densitometry

Diagnostic Test

Retrospective quantification of lesion water uptake by CT densitometry in admission and follow-up imaging

Primary outcomes

  1. modified ranking scale on day (mRs) day 90

    Time frame: 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 outcomes

  1. Ischemic lesion water uptake on admission

    Time frame: 0-24 hours after symptom onset

    Ischemic lesion water uptake is a CT based quantitative imaging biomarker to assess ischemic edema based on densitometry

  2. Ischemic lesion water uptake on follow-up imaging

    Time frame: 24-48 hours after admission

    Ischemic lesion water uptake is a CT based quantitative imaging biomarker to assess ischemic edema based on densitometry

Study contacts

Contact information is provided by the study sponsor or research team.

Andre Kemmling, MD, MHBA

CONTACT

[email protected]

Gabriel Broocks, MD

CONTACT

[email protected]

+4915222817182

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • Charite University, Berlin, Germany
  • Klinikum Bremen-Mitte, gGmbH
  • University Hospital Muenster
  • University Hospital, Basel, Switzerland
  • University of Kaiserslautern
  • University of Rostock

Registry information

Official study title

Improving Low Alberta Stroke Program Early ct Score Stroke Thrombectomy

Acronym: I-LAST

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Apr 28, 2021
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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