Trial document




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  DRKS00012454

Trial Description

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Title

INSU Cor Study: Insular – non Insular Stroke Underlying Cardiac failure

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Trial Acronym

INSU Cor

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URL of the Trial

http://www.epidemiologie.uni-wuerzburg.de/projekte/kk/insu_cor/

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Brief Summary in Lay Language

Within the study, ischemic stroke patients of the University Hospital Würzburg are to be examined for a new heart failure during their hospital stay. In addition to the blood sampling and echocardiography performed routinely in all ischemic stroke patients, a further echo is performed with a smaller device at the stroke unit. If there is no heart failure, permission is requested to take further blood samples, perform more precise clinical examinations, and interviews focused on cardiovascular and comorbidities that are associated with ischemic stroke. The patients are then examined echocardiographically and clinically (for example, cardiac noises, blood pressure fluctuations) and interviewed three times (after 1 week, 4 and 12 weeks) for a new failure.

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Brief Summary in Scientific Language

The aim of the INSU Cor study is the description of the development of new systolic dysfunction (LVEF changes) after ischemic stroke with involvement of the insular cortex and identification of factors associated with this new systolic dysfunction.
In addition, the differences between ischemic stroke patients with and without insular involvement, who were free from systolic dysfunction at the baseline, over the first three months after the index event are examined in other echocardiographic markers (eg E / E ', Strain) other variables of cardiac function (Heart rate variability, cardiac arrhythmias, blood pressure changes, blood-based biomarkers such as troponin T and NTproBNP), which indicate on the symptom onset.
As well the differences between cases and controls in the natural course of stroke-related comorbidities such as affect and cognition as well as identification of the relationship of these comorbidities to cardiovascular diseases in the first 3 months after ischemic stroke are recorded.

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Organizational Data

  •   DRKS00012454
  •   2017/08/02
  •   [---]*
  •   yes
  •   Approved
  •   130/17, Ethik-Kommission der Medizinischen Fakultät der Universität Würzburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   I63 -  Cerebral infarction
  •   I64 -  Stroke, not specified as haemorrhage or infarction
  •   I50 -  Heart failure
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Interventions/Observational Groups

  •   For stroke patients with and without involvement of the insular cortex blood-based biomarkers as well as interviews concerning cardiovascular and concomitant diseases, medication and risk factors. There is no intervention.
    But the ischemic stroke patients free of systolic dysfunction are divided into two groups.
    Cases are ischemic stroke patients with involvement of the insular cortex,
    controls are free of involvement of the insular cortex.
    Cases and controls are compared by means of echocardiographic and clinical exams, blood based biomarkers, interviews about comorbidities, medication and risk factors. After 1 week as well as 4 and 12 weeks are cases and controls aging compared by means of echocardiographic and clinical exams, interviews and blood based biomarkers.
  •   There is no intervention. The stroke patients who are free from systolic dysfunction in study inclusion are divided into 2 groups.
    Controls are patients without involvement of the insular cortex.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Parallel
  •   [---]*
  •   [---]*
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Primary Outcome

The primary endpoint is the development of new systolic dysfunction in ischemic cerebral infarction patients with involvement of the insular cortex within the first three months after index event.

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Secondary Outcome

Identification of comorbidities (rehospitalisation rate, degree of independence, cognition, depression, anxiety) after 3 months, that are associated with development of a new systolic dysfunktion within the first three months after ischemic stroke
Cases and controls are compared by means of echocardiographic and clinical exams, blood based biomarkers, interviews about comorbidities, medication and risk factors after 1 week as well as 4 and 12 weeks.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/10/19
  •   180
  •   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

Ischemic stroke according to the WHO definition (Hatano 1976) or the corresponding lesion in cerebral imaging irrespective of the duration of the symptoms, maximum 3 days before inclusion with (cases) vs. without involvement (control) of the insular cortex
In screening by handheld or routine echocardiography free of systolic dysfunction
Written consent of the patient or written consent of the legal representative or relative is available
Sufficient German language skills

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Exclusion Criteria

The exclusion criterion is the inclusion of the patient in an acute intervention / AMG study in order to monitor the natural course of cardiovascular diseases as well as comorbidities
Patients who were initially diagnosed with a stroke but who were subsequently diagnosed with a different diagnosis
Systolic dysfunction in screening
Lack of readiness / ability to perform follow-up appointments

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Addresses

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    • Universitätsklinikum WürzburgNeurologischen Klinik und Poliklinik
    • Mr.  Prof. Dr.  Jens  Volkmann 
    • Josef-Schneider-Straße 11
    • 97080  Würzburg
    • Germany
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    • Institut für Klinische Epidemiologie und Biometrie (IKE-B) der Universität Würzburg
    • Mr.  Prof. Dr  Peter Ulrich  Heuschmann 
    • Josef-Schneider-Str. 2 / Haus D7
    • 97080  Würzburg
    • Germany
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    • Deutsches Zentrum für Herzinsuffizienz WürzburgComprehensive Heart Failure Center
    • Mr.  Prof. Dr.  Stefan  Störk 
    • Am Schwarzenberg 15
    • 97078  Würzburg
    • Germany
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    • Institut für Diagnostische und Interventionelle Neuroradiologie
    • Mr.  Prof. Dr  Mirko  Pham 
    • Josef-Schneider-Straße 11
    • 97080  Würzburg
    • Germany
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    • Institut für Klinische Epidemiologie und Biometrie (IKE-B) der Universität Würzburg
    • Mr.  Prof. Dr  Peter Ulrich  Heuschmann 
    • Josef-Schneider-Str. 2 / Haus D7
    • 97080  Würzburg
    • Germany
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    • Neurologische Klinik und PoliklinikUniversitätsklinikum WürzburgInstitut für Klinische Epidemiologie und BiometrieUniversität Würzburg
    • Mr.  Daniel  Mackenrodt 
    • Josef Schneiderstraße 11
    • 97080  Würzburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Zentrum für Herzinsuffizienz (DZHI)Universitätsklinikum Würzburg
    • Am Schwarzenberg 15
    • 97078  Würzburg
    • 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.