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Ischemic StrokeSTAMINANCT04357899

Stroke Research Consortium in Northern Bavaria (STAMINA)

An observational study of Ischemic Stroke, run by University of Erlangen-Nürnberg Medical School at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke
What is being tested?
thrombolysis therapy, endovascular therapy and decompressive surgery
How many people
3,769 participants
Where
2 sitesGermany
Study dates
1 Jan 2006to 31 Mar 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • Age < 18 years

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Institut für Neuroradiologie, Universitätsklinikum Erlangen

    Erlangen, 91054

  • Neurologische Klinik, Universitätsklinikum Erlangen

    Erlangen, 91054

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Conditions
Ischemic Stroke
Being tested
thrombolysis therapy, endovascular therapy, decompressive surgery, multimodal imaging in acute ischemic stroke, transfer of acute stroke patients to tertiary stroke centers
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
Medical subject headings
Ischemic Stroke, Stroke, Cerebrovascular Disorders, Brain Diseases, Brain Ischemia, Cerebral Infarction, Central Nervous System Diseases, Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • thrombolysis therapyDrug

    Also called thrombolytic drugs

  • endovascular therapyProcedure or surgery

  • decompressive surgeryProcedure or surgery

  • multimodal imaging in acute ischemic strokeDiagnostic test

  • transfer of acute stroke patients to tertiary stroke centersProcedure or surgery

  • initiation of antiplatelets, oral anticoagulation and lipid lowering drugs for secondary preventionDrug

    Also called antithrombotic oder lipid lowering drugs

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: at day 90

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

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

    Measured: at day 90

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

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

    Measured: at day 90

  4. Infarct volume

    Infarct volume on CT or diffusion-weighted MRI

    Measured: at day 5 (±2)

  5. Lesion growth volume

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

    Measured: at day 5 (±2)

  6. 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

    Measured: at 24 (±6) hours

  7. Recanalization Rates

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

    Measured: at 24 (±6) hours

Secondary outcomes (6)

  1. Mortality

    All cause mortality rate

    Measured: at 90 days

  2. Procedure time

    Time from groin puncture to first recanalization

    Measured: procedure

  3. Door-to-groin puncture time

    Time from arrival at the tertiary stroke center to groin puncture

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

  4. Door-to-needle time

    Time from hospital arrival to IVT administration

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

  5. Symptom-to-door time

    Time from symptom onset to arrival at the first hospital

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

  6. Interhospital transfer time

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2020
  2. Study start1 Jan 2006
  3. Primary completion31 Dec 2019
  4. Study completion31 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,769 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04357899
Sponsor's protocol ID
33_20B
Acronym
STAMINA
Status last verified
Apr 2021
First submitted
16 Apr 2020
Last updated
2 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Because of local ethics committees restrictions the final decision upon release of the raw data has not been made.

Publications

  • 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.

    PubMed 39182487

  • 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.

    PubMed 39049127

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Stroke, run by University of Erlangen-Nürnberg Medical School at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Outcome (modified Rankin Scale 0-6) (time frame: at day 90). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04357899, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.

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