Acute Ischemic Stroke Clinical Trial
— I-LASTOfficial title:
Improving Low Alberta Stroke Program Early ct Score Stroke Thrombectomy
NCT number | NCT04862507 |
Other study ID # | I-LAST |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2023 |
Est. completion date | January 1, 2028 |
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | January 1, 2028 |
Est. primary completion date | January 1, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Charite University Berlin | Berlin | |
Germany | Hospital Bremen-Mitte | Bremen | |
Germany | University Medical Center Hamburg-Eppendorf | Hamburg | |
Germany | Westpfalzklinikum | Kaiserslautern | |
Germany | University Hospital Marburg | Marburg | |
Germany | University Münster | Münster | |
Germany | University Rostock | Rostock | |
Switzerland | University Basel | Basel |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf | Charite University, Berlin, Germany, Klinikum Bremen-Mitte, gGmbH, University Hospital Muenster, University Hospital, Basel, Switzerland, University of Kaiserslautern, University of Rostock |
Germany, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 |
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