Trial document





This trial has been registered retrospectively.
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  DRKS00017253

Trial Description

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Title

Gutenberg Stroke Study - Identification and characterization of markers for etiology, clinical course and Treatment-Response in patients with vascular diseases of the CNS

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Trial Acronym

GSS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Main purpose/background:
The treatment options of stroke are time sensitive and exhibiting risk such as cerebral bleeding. We therefore aim to elucidate biomarkers in the blood to confine diagnosis of stroke and gain insight into clinical outcome and response to approved therapies.

What will be done?
Participants will be followed up via telephone interview 3 months after the index event. Within the hospital stay blood samples will be collected.

Which persons can participate?
Patients with ischemic stroke, which are able to give informed consent and age above 18 years.

Which outcomes will be evaluated?
The following outcomes will be evaluated: Functional independence after 3 months, adverse events after the index stroke, periprocedural characteristics.

Which hypothesis will be tested?
Identification of markers for pathophysiology and clinical outcome after stroke.

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Brief Summary in Scientific Language

Main purpose / background:
This monocentric, prospective, non-interventional Cohort-Study aims to identify and characterize biomarkers for the pathophysiology of vascular diseases of the central nervous System. In a second step these markers will be used to predict clinical course and response to approved therapies such as intravenous thrombolysis and endovascular thrombectomy.

What will be done?
Participants will be followed up via telephone interview 3 months after the index event, modified Rankin Scale, Telephone-Moca.
Within the hospital stay blood samples will be collected, maximum 90 ml, EDTA-, Serum-Samples.

Which persons can participate?
Inclusion criteria:
- Patients with vascular diseases of the CNS
- informed consent
- aged above 18 years
Exclusion criteria:
- no informed consent
- no vascular diseases of the CNS
- aged below 18 years

Which outcomes will be evaluated?
90d mRS, Telephone-Moca, periprocedural characteristics, clinical course, adverse events such as pneumonia, intracranial bleeding, hemicraniectomy.

Which hypothesis will be tested?
Identification of markers for pathophysiology and clinical outcome after stroke.

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Organizational Data

  •   DRKS00017253
  •   2019/05/16
  •   [---]*
  •   yes
  •   Approved
  •   2018-13335-Epidemiologie, Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

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Health Condition or Problem studied

  •   I64 -  Stroke, not specified as haemorrhage or infarction
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Interventions/Observational Groups

  •   Patients with Stroke undergo the following interventions/diagnostic procedures:
    - blood donation (within the hospital stay, possibly during outpatient visits).
    - telephone interview 90 days after the index stroke (EQ-5D, mRS, QVSFS, MoCA)
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

modified Rankin Scale 90d after event, EQ-5D 90d after event, Telephone Moca (Montreal Cognitive Assessment) 90d after event

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Secondary Outcome

periprocedural characteristics (within Hospital stay), Death (90 days after stroke), Re-Ischemia (QVSFS) 90 days after stroke.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/01/01
  •   1000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Stroke 2. Informed Consent available

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Exclusion Criteria

1. No informed consent 2. <18 years

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Addresses

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    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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    • Universitätsmedizin Mainz Klinik und Poliklinik für Neurologie
    • Mr.  Prof.  Klaus  Gröschel 
    • Langenbeckstr. 1
    • 55131  Mainz
    • Germany
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    • Universitätsmedizin Mainz Klinik und Poliklinik für Neurologie
    • Mr.  Dr. med.  Timo  Uphaus 
    • Langenbeckstr. 1
    • 55131  Mainz
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz Klinik und Poliklinik für Neurologie
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.