Clinical trial NCT04357899: Stroke Research Consortium in Northern Bavaria (STAMINA)
Official title: Stroke Research Consortium in Northern Bavaria - STAMINA, a Multicenter Longitudinal Cohort Study on Ischemic Stroke Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Keywords: 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
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 3769
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ischemic stroke patients treated within a stroke care network in Northern Bavaria, Germany.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Outcome (modified Rankin Scale 0-6)
timeFrame: at day 90
measure: Functional Independence (modified Rankin Scale 0-2)
timeFrame: at day 90
measure: Favorable Outcome (modified Rankin Scale 0-1)
timeFrame: at day 90
measure: Infarct volume
timeFrame: at day 5 (±2)
measure: Lesion growth volume
timeFrame: at day 5 (±2)
measure: Intracranial hemorrhage
timeFrame: at 24 (±6) hours
measure: Recanalization Rates
timeFrame: at 24 (±6) hours
Secondary outcomes:
measure: Mortality
timeFrame: at 90 days
measure: Procedure time
timeFrame: procedure
measure: Door-to-groin puncture time
timeFrame: until 24 hours after admission to the tertiary stroke center or until hospital discharge, whichever came first
measure: Door-to-needle time
timeFrame: until 24 hours after admission to the tertiary stroke center or until hospital discharge, whichever came first
measure: Symptom-to-door time
timeFrame: until 24 hours after admission to the tertiary stroke center or until hospital discharge, whichever came first
measure: Interhospital transfer time
timeFrame: until 24 hours after admission to the tertiary stroke center or until hospital discharge, whichever came first
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Institut für Neuroradiologie, Universitätsklinikum Erlangen
city: Erlangen
country: Germany
facility: Neurologische Klinik, Universitätsklinikum Erlangen
Study officials:
affiliation: Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Department of Neurology, Germany
name: Stefan Schwab
role: PRINCIPAL_INVESTIGATOR
affiliation: Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Department of Neuroradiology, Germany
name: Arnd Dörfler
role: PRINCIPAL_INVESTIGATOR
affiliation: Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Department of Neurology, Germany
name: Bernd Kallmünzer
role: PRINCIPAL_INVESTIGATOR
affiliation: Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Department of Neuroradiology, Germany
name: Tobias Engelhorn
role: PRINCIPAL_INVESTIGATOR
References: