Stroke Research Consortium in Northern Bavaria (STAMINA) (STAMINA)

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

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke
• Intervention / Treatment: 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

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.

• Study Type: Observational
• Enrollment (Actual): 3769

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, 91054
    • Institut für Neuroradiologie, Universitätsklinikum Erlangen
  • Erlangen, Germany, 91054
    • Neurologische Klinik, Universitätsklinikum Erlangen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Ischemic stroke patients treated within a stroke care network in Northern Bavaria, Germany.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2006
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): March 31, 2020

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (ACTUAL): April 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 2, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Stroke; Vascular Diseases; Cardiovascular Diseases; Nervous System Diseases; Central Nervous System Diseases; Brain Diseases; Cerebral Infarction; Cerebrovascular Disorders; Brain Ischemia; Thrombolysis; Mechanical thrombectomy; Tissue Plasminogen Activator; Fibrinolytic Agents; Fibrin Modulating Agents; Endovascular procedure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Lipid Regulating Agents; Hypolipidemic Agents
• Other Study ID Numbers: 33_20B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Because of local ethics committees restrictions the final decision upon release of the raw data has not been made.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No