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Completed

NCT Number: NCT04357899

Stroke Research Consortium in Northern Bavaria (STAMINA)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut für Neuroradiologie, Universitätsklinikum Erlangen, Erlangen, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

thrombolysis therapy

Drug

Other names: thrombolytic drugs

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

Other names: antithrombotic oder lipid lowering drugs

Primary outcomes

  1. Functional Outcome (modified Rankin Scale 0-6)

    Time frame: at day 90

    The Distribution of Scores on the modified Rankin Scale (mRS)

  2. Functional Independence (modified Rankin Scale 0-2)

    Time frame: at day 90

    Proportion of participants with functional independence (mRS 0-2)

  3. Favorable Outcome (modified Rankin Scale 0-1)

    Time frame: at day 90

    Proportion of participants with favorable outcome (mRS 0-1)

  4. Infarct volume

    Time frame: at day 5 (±2)

    Infarct volume on CT or diffusion-weighted MRI

  5. Lesion growth volume

    Time frame: at day 5 (±2)

    Lesion growth volume between ischemic core on baseline imaging and infarkt volume

  6. Intracranial hemorrhage

    Time frame: at 24 (±6) hours

    Rate of intracranial hemorrhage defined according to different criteria (ECASS II, SITS-MOST, NINDS or Parenchymal hemorrhage Type 2) on the 24 hour scan

  7. Recanalization Rates

    Time frame: at 24 (±6) hours

    Recanalization of the primary arterial occlusive lesion (based on ultrasound, clinical and radiological assessment) at 24-hours

Secondary outcomes

  1. Mortality

    Time frame: at 90 days

    All cause mortality rate

  2. Procedure time

    Time frame: procedure

    Time from groin puncture to first recanalization

  3. Door-to-groin puncture time

    Time frame: until 24 hours after admission to the tertiary stroke center or until hospital discharge, whichever came first

    Time from arrival at the tertiary stroke center to groin puncture

  4. Door-to-needle time

    Time frame: until 24 hours after admission to the tertiary stroke center or until hospital discharge, whichever came first

    Time from hospital arrival to IVT administration

  5. Symptom-to-door time

    Time frame: until 24 hours after admission to the tertiary stroke center or until hospital discharge, whichever came first

    Time from symptom onset to arrival at the first hospital

  6. Interhospital transfer time

    Time frame: until 24 hours after admission to the tertiary stroke center or until hospital discharge, whichever came first

    Time from arrival at the first hospital to arrival at the tertiary stroke center

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

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

Acronym: STAMINA

Important dates

Study start
2006
Primary completion
2019
Study completion
2020
First posted
Apr 22, 2020
Registry last updated
Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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