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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thrombolysis therapy | Drug |
| ||
| endovascular therapy | Procedure | |||
| decompressive surgery | Procedure | |||
| multimodal imaging in acute ischemic stroke | Diagnostic Test | |||
| transfer of acute stroke patients to tertiary stroke centers | Procedure | |||
| initiation of antiplatelets, oral anticoagulation and lipid lowering drugs for secondary prevention | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional Outcome (modified Rankin Scale 0-6) | The Distribution of Scores on the modified Rankin Scale (mRS) | at day 90 |
| Functional Independence (modified Rankin Scale 0-2) | Proportion of participants with functional independence (mRS 0-2) | at day 90 |
| Favorable Outcome (modified Rankin Scale 0-1) | Proportion of participants with favorable outcome (mRS 0-1) | at day 90 |
| Infarct volume | Infarct volume on CT or diffusion-weighted MRI | at day 5 (±2) |
| Lesion growth volume | Lesion growth volume between ischemic core on baseline imaging and infarkt volume | at day 5 (±2) |
| 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 |
| Recanalization Rates | Recanalization of the primary arterial occlusive lesion (based on ultrasound, clinical and radiological assessment) at 24-hours | at 24 (±6) hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | All cause mortality rate | at 90 days |
| Procedure time | Time from groin puncture to first recanalization | procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Ischemic stroke patients treated within a stroke care network in Northern Bavaria, Germany.
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Schwab | Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Department of Neurology, Germany | Principal Investigator |
| Arnd Dörfler | Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Department of Neuroradiology, Germany | Principal Investigator |
| Bernd Kallmünzer | Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Department of Neurology, Germany | Principal Investigator |
| Tobias Engelhorn | Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Department of Neuroradiology, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut für Neuroradiologie, Universitätsklinikum Erlangen | Erlangen | 91054 | Germany | |||
| Neurologische Klinik, Universitätsklinikum Erlangen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39182487 | Derived | Macha K, Sembill JA, Muehlen I, Engelhorn T, Doerfler A, Schwab S, Kallmunzer B. IV Thrombolysis for Acute Ischemic Stroke with Unknown Onset in Patients on Oral Anticoagulation. Cerebrovasc Dis. 2025;54(4):499-507. doi: 10.1159/000540552. Epub 2024 Aug 23. | |
| 39049127 | Derived | Sembill JA, Sprugel MI, Haupenthal D, Kremer S, Knott M, Muhlen I, Kallmunzer B, Kuramatsu JB. Endovascular thrombectomy in patients with anterior circulation stroke: an emulated real-world comparison. Neurol Res Pract. 2024 Jul 25;6(1):37. doi: 10.1186/s42466-024-00331-6. |
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Because of local ethics committees restrictions the final decision upon release of the raw data has not been made.
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| 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 |
| 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 |
| 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 |
| 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 |
| Erlangen |
| 91054 |
| Germany |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002545 | Brain Ischemia |
| D002544 | Cerebral Infarction |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D020520 | Brain Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D015912 | Thrombolytic Therapy |
| D005343 | Fibrinolytic Agents |
| D064847 | Multimodal Imaging |
| D055502 | Secondary Prevention |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D050299 | Fibrin Modulating Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D006401 | Hematologic Agents |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D015980 | Public Health Practice |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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