Stroke Research Consortium in Northern Bavaria (STAMINA)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Stroke Research Consortium in Northern Bavaria - STAMINA, a Multicenter Longitudinal Cohort Study on Ischemic Stroke Treatment

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: thrombolysis therapy
* Procedure: endovascular therapy
* Procedure: 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: thrombolysis therapy|nan|
|Procedure: endovascular therapy|nan|
|Procedure: decompressive surgery|nan|
|Diagnostic Test: multimodal imaging in acute ischemic stroke|nan|
|Procedure: transfer of acute stroke patients to tertiary stroke centers|nan|
|Drug: initiation of antiplatelets, oral anticoagulation and lipid lowering drugs for secondary prevention|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | All cause mortality rate | at 90 days | 
| Procedure time | Time from groin puncture to first recanalization | procedure | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thrombolysis, Mechanical thrombectomy, Endovascular procedure, Stroke, Cerebrovascular Disorders, Brain Diseases, Brain Ischemia, Cerebral Infarction, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases, Tissue Plasminogen Activator, Fibrinolytic Agents, Fibrin Modulating Agents