Stroke Research Consortium in Northern Bavaria (STAMINA)

NCT04357899 | Completed

• 1 other identifier: 33_20B
• Study Type: observational
• Target: 3,769
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (6)

• Mortality

  at 90 days

• Procedure time

  procedure

• Door-to-groin puncture time

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

• Door-to-needle time

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

• Symptom-to-door time

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

Interventions

thrombolysis therapy DRUG

Also known as: 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

Also known as: antithrombotic oder lipid lowering drugs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (2)

Institut für Neuroradiologie, Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Neurologische Klinik, Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Related Publications (2)

• 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.

  PMID: 39182487 DERIVED

• 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.

  PMID: 39049127 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Cerebrovascular Disorders; Brain Diseases; Brain Ischemia; Cerebral Infarction; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Interventions

Thrombolytic Therapy; Fibrinolytic Agents; Multimodal Imaging; Secondary Prevention

Condition Hierarchy (Ancestors)

Brain Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Cardiovascular Agents; Therapeutic Uses; Hematologic Agents; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 22, 2020
• Study Start: January 1, 2006
• Primary Completion: December 31, 2019
• Study Completion: March 31, 2020
• Last Updated: August 2, 2022

Record last verified: 2021-04

Locations

DE (2)