NCT04862507

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started May 2023

Longer than P75 for all trials

Geographic Reach
2 countries

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
May 2023Jan 2028

First Submitted

Initial submission to the registry

April 13, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
2 years until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

3.7 years

First QC Date

April 13, 2021

Last Update Submit

May 23, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Ischemic lesion water uptake on admission

    0-24 hours after symptom onset

  • Ischemic lesion water uptake on follow-up imaging

    24-48 hours after admission

Study Arms (2)

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 90Diagnostic Test: Quantification of lesion water uptake by CT densitometry

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 90Diagnostic Test: Quantification of lesion water uptake by CT densitometry

Interventions

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

Stroke Patients with an ASPECTS of 0-5 on baseline neuroimaging not undergoing thrombectomyStroke Patients with an ASPECTS of 0-5 on baseline neuroimaging undergoing thrombectomy

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 thrombectomyStroke Patients with an ASPECTS of 0-5 on baseline neuroimaging undergoing thrombectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Charite University Berlin

Berlin, Germany

ENROLLING BY INVITATION

Hospital Bremen-Mitte

Bremen, Germany

ENROLLING BY INVITATION

University Medical Center Hamburg-Eppendorf

Hamburg, 20251, Germany

RECRUITING

Westpfalzklinikum

Kaiserslautern, Germany

ENROLLING BY INVITATION

University Hospital Marburg

Marburg, Germany

RECRUITING

University Münster

Münster, Germany

ENROLLING BY INVITATION

University Rostock

Rostock, Germany

ENROLLING BY INVITATION

University Basel

Basel, Switzerland

ENROLLING BY INVITATION

Related Publications (1)

  • Broocks G, Meyer L, Elsayed S, McDonough R, Bechstein M, Faizy TD, Sporns P, Schon G, Minnerup J, Kniep HC, Hanning U, Barow E, Schramm P, Langner S, Nawabi J, Papanagiotou P, Wintermark M, Lansberg MG, Albers GW, Heit JJ, Fiehler J, Kemmling A; I-LAST Investigators. Association Between Net Water Uptake and Functional Outcome in Patients With Low ASPECTS Brain Lesions: Results From the I-LAST Study. Neurology. 2023 Feb 28;100(9):e954-e963. doi: 10.1212/WNL.0000000000201601. Epub 2022 Nov 22.

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Gabriel Broocks, MD

CONTACT

Andre Kemmling, MD, MHBA

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Principal Investigator

Study Record Dates

First Submitted

April 13, 2021

First Posted

April 28, 2021

Study Start

May 1, 2023

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

May 24, 2023

Record last verified: 2023-05

Locations