Stroke Research Consortium in Northern Bavaria (STAMINA)

Ischemic Stroke Clinical Trial

— STAMINA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04357899
• Other study ID #: 33_20B
• Status: Completed
• Start date: January 1, 2006
• Est. completion date: March 31, 2020

Study information

• Verified date: April 2021
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3769
• Est. completion date: March 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Drug:
• thrombolysis therapy

Procedure:
• endovascular therapy

• 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

Locations

Country	Name	City	State
Germany	Institut für Neuroradiologie, Universitätsklinikum Erlangen	Erlangen
Germany	Neurologische Klinik, Universitätsklinikum Erlangen	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Outcome (modified Rankin Scale 0-6)	The Distribution of Scores on the modified Rankin Scale (mRS)	at day 90
Primary	Functional Independence (modified Rankin Scale 0-2)	Proportion of participants with functional independence (mRS 0-2)	at day 90
Primary	Favorable Outcome (modified Rankin Scale 0-1)	Proportion of participants with favorable outcome (mRS 0-1)	at day 90
Primary	Infarct volume	Infarct volume on CT or diffusion-weighted MRI	at day 5 (±2)
Primary	Lesion growth volume	Lesion growth volume between ischemic core on baseline imaging and infarkt volume	at day 5 (±2)
Primary	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
Primary	Recanalization Rates	Recanalization of the primary arterial occlusive lesion (based on ultrasound, clinical and radiological assessment) at 24-hours	at 24 (±6) hours
Secondary	Mortality	All cause mortality rate	at 90 days
Secondary	Procedure time	Time from groin puncture to first recanalization	procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	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