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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04357899
Other study ID # 33_20B
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2006
Est. completion date March 31, 2020

Study information

Verified date April 2021
Source University of Erlangen-Nürnberg Medical School
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Each year, approximately 15 million people suffer a stroke worldwide of which 80% are due to ischemic cerebral infarction. Based on the results of randomized controlled trials, treatment options and patient outcomes in acute ischemic stroke have dramatically improved in recent years. However, these advances in thrombolysis and endovascular therapy need to be established outside controlled trials to optimize stroke management, treatment procedures, patient selection and inter-hospital transfer in clinical practice. This multicenter longitudinal cohort study is based on a large stroke care network in Northern Bavaria, Germany (region of more than 3.5 million inhabitants) to evaluate and improve treatment in ischemic stroke.


Description:

Methods: This multicenter longitudinal cohort study will include ischemic stroke patients treated within a telemedical stroke care network and patients transferred to tertiary stroke centers for treatment procedures from hospitals outside the telemedical network. Individual patient data are available from two tertiary stroke centers and 24 primary and secondary stroke facilities in Northern Bavaria, Germany. Patients with ischemic stroke transferred to the tertiary stroke centers for treatment procedures - i.e. endovascular therapy or thrombolysis in stroke with an unknown time of onset - and all stroke patients with either large vessel occlusion (LVO) and/or thrombolysis therapy admitted to the University Hospital Erlangen will be integrated from institutional prospective stroke registries. Consecutive patients admitted between January 2006 and December 2019 will be included, an estimated total number of more than 3000 ischemic stroke patients - approximately 1000 patients with LVO receiving endovascular therapy, 1000 patients with LVO not receiving endovascular therapy and 1000 patients without LVO receiving thrombolysis therapy. Demographic and clinical data including medical history, medication and laboratory results will be obtained by review of medical charts, institutional databases or prospective registries, supplemented by structured interviews on follow-up information or by review of all available medical records. In detail the following parameters will be evaluated: prior medical history (e.g. comorbidities, premorbid functional status, medication), admission status (e.g. NIHSS, GCS, body temperature, arterial blood pressure), cerebral imaging parameters (e.g. Alberta Stroke Program Early CT score [ASPECTS], perfusion volumes, mismatch and collateral status on admission imaging, final infarct volume on follow-up imaging), treatment procedures (e.g. intravenous thrombolysis, endovascular therapy, decompressive surgery), time intervals (e.g. symptom onset or last seen normal until admission, imaging, thrombolysis, groin puncture, recanalization), complications (e.g. hemorrhagic transformation, arterial dissection, distant ischemic stroke), laboratory parameters, clinical and diagnostic follow-up (e.g. neurological status, blood pressure, vascular ultrasound), stroke etiology, secondary prevention (e.g. lipid lowering medication, antiplatelet therapy, anticoagulation) and clinical outcomes (e.g. mortality, modified Rankin Scale). Ethics Approval: The study was approved by the Institutional Review Board of the Friedrich-Alexander-Universität Erlangen-Nürnberg.


Recruitment information / eligibility

Status Completed
Enrollment 3769
Est. completion date March 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke - Presence of large vessel occlusion (as evidenced by CTA, MRA or DSA) and/or intravenous thrombolysis therapy applied Exclusion Criteria: - Age < 18 years

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
thrombolysis therapy

Procedure:
endovascular therapy

decompressive surgery

Diagnostic Test:
multimodal imaging in acute ischemic stroke

Procedure:
transfer of acute stroke patients to tertiary stroke centers

Drug:
initiation of antiplatelets, oral anticoagulation and lipid lowering drugs for secondary prevention


Locations

Country Name City State
Germany Institut für Neuroradiologie, Universitätsklinikum Erlangen Erlangen
Germany Neurologische Klinik, Universitätsklinikum Erlangen Erlangen

Sponsors (1)

Lead Sponsor Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Functional Outcome (modified Rankin Scale 0-6) The Distribution of Scores on the modified Rankin Scale (mRS) at day 90
Primary Functional Independence (modified Rankin Scale 0-2) Proportion of participants with functional independence (mRS 0-2) at day 90
Primary Favorable Outcome (modified Rankin Scale 0-1) Proportion of participants with favorable outcome (mRS 0-1) at day 90
Primary Infarct volume Infarct volume on CT or diffusion-weighted MRI at day 5 (±2)
Primary Lesion growth volume Lesion growth volume between ischemic core on baseline imaging and infarkt volume at day 5 (±2)
Primary Intracranial hemorrhage Rate of intracranial hemorrhage defined according to different criteria (ECASS II, SITS-MOST, NINDS or Parenchymal hemorrhage Type 2) on the 24 hour scan at 24 (±6) hours
Primary Recanalization Rates Recanalization of the primary arterial occlusive lesion (based on ultrasound, clinical and radiological assessment) at 24-hours at 24 (±6) hours
Secondary Mortality All cause mortality rate at 90 days
Secondary Procedure time Time from groin puncture to first recanalization procedure
Secondary Door-to-groin puncture time Time from arrival at the tertiary stroke center to groin puncture until 24 hours after admission to the tertiary stroke center or until hospital discharge, whichever came first
Secondary Door-to-needle time Time from hospital arrival to IVT administration until 24 hours after admission to the tertiary stroke center or until hospital discharge, whichever came first
Secondary Symptom-to-door time Time from symptom onset to arrival at the first hospital until 24 hours after admission to the tertiary stroke center or until hospital discharge, whichever came first
Secondary Interhospital transfer time Time from arrival at the first hospital to arrival at the tertiary stroke center until 24 hours after admission to the tertiary stroke center or until hospital discharge, whichever came first
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