Acute Ischemic StrokeI-LASTNCT04862507
Improving Low ASPECTS Stroke Thrombectomy
An observational study of Acute Ischemic Stroke, run by Universitätsklinikum Hamburg-Eppendorf at 8 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Telephone call on day 90 and Quantification of lesion water uptake by CT densitometry
- How many people
- 500 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 1 May 2023to 1 Jan 2028
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Andre Kemmling, MD, MHBA contact
8 sites in 2 countries
Germany7 sites, 7 recruiting
- Enrolling by invitation
Charite University Berlin
Berlin
- Enrolling by invitation
Hospital Bremen-Mitte
Bremen
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, 20251
Gabriel Broocks, MD
- Enrolling by invitation
Westpfalzklinikum
Kaiserslautern
- Recruiting
University Hospital Marburg
Marburg
Andre Kemmling, MD
- Enrolling by invitation
University Münster
Münster
- Enrolling by invitation
University Rostock
Rostock
Switzerland1 site, 1 recruiting
- Enrolling by invitation
University Basel
Basel
About this study
Official title: 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.
Read the 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).
- Conditions
- Acute Ischemic Stroke
- Being tested
- Telephone call on day 90, Quantification of lesion water uptake by CT densitometry
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone call on day 90Other
telephone call on day 90 to assess the primary outcome (mRs 90)
Quantification of lesion water uptake by CT densitometryDiagnostic test
Retrospective quantification of lesion water uptake by CT densitometry in admission and follow-up imaging
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Telephone call on day 90; Diagnostic 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 Receives: Other: Telephone call on day 90; Diagnostic Test: Quantification of lesion water uptake by CT densitometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (2)
Ischemic lesion water uptake on admission
Ischemic lesion water uptake is a CT based quantitative imaging biomarker to assess ischemic edema based on densitometry
Measured: 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
Measured: 24-48 hours after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 May 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kaiserslautern, University Hospital Muenster, University of Rostock, University Hospital, Basel, Switzerland, Charite University, Berlin, Germany, Klinikum Bremen-Mitte, gGmbH
- Responsible party
- Principal investigator, Gabriel Broocks, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862507
- Sponsor's protocol ID
- I-LAST
- Acronym
- I-LAST
- Status last verified
- May 2023
- First submitted
- 13 Apr 2021
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared upon reasonable request.
Publications
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.
PubMed 36414425
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Low Alberta Stroke Program Early ct Score Stroke Thrombectomy
- ClinicalTrials.gov ID
- NCT04862507
- Acronym / sponsor ID
- I-LAST / I-LAST
- Conditions
- Acute Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- University of Kaiserslautern, University Hospital Muenster, University of Rostock, University Hospital, Basel, Switzerland, Charite University, Berlin, Germany, Klinikum Bremen-Mitte, gGmbH
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke Patients with an ASPECTS of 0-5 on baseline neuroimaging undergoing thrombectomy | – | Other: Telephone call on day 90, Diagnostic Test: Quantification of lesion water uptake by CT densitometryacute stroke patients treated with endovascular treatment combined with thrombolysis or without previous thrombolysis Intervention. |
| Stroke Patients with an ASPECTS of 0-5 on baseline neuroimaging not undergoing thrombectomy | – | Other: Telephone call on day 90, Diagnostic Test: Quantification of lesion water uptake by CT densitometryacute stroke patients treated with or without thrombolysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone call on day 90telephone call on day 90 to assess the primary outcome (mRs 90) | Other | Stroke Patients with an ASPECTS of 0-5 on baseline neuroimaging not undergoing thrombectomy, Stroke Patients with an ASPECTS of 0-5 on baseline neuroimaging undergoing thrombectomy |
| Quantification of lesion water uptake by CT densitometryRetrospective quantification of lesion water uptake by CT densitometry in admission and follow-up imaging | Diagnostic test | Stroke Patients with an ASPECTS of 0-5 on baseline neuroimaging not undergoing thrombectomy, Stroke Patients with an ASPECTS of 0-5 on baseline neuroimaging undergoing thrombectomy |
Primary outcome
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.
2 secondary outcomes
Ischemic lesion water uptake on admission
Time frame: 0-24 hours after symptom onset
Ischemic lesion water uptake on follow-up imaging
Time frame: 24-48 hours after admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Derived from this study: PubMed 36414425Broocks 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.
- Individual participant dataSharing planned: Undecided. Data will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andre Kemmling, MD, MHBA contact
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Universitätsklinikum Hamburg-Eppendorf at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriel Broocks, MD (+4915222817182, g.broocks@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified ranking scale on day (mRs) day 90 (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04862507, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.