Trial document





This trial has been registered retrospectively.
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  DRKS00008931

Trial Description

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Title

Dynamics of cardiovascular autonomic disturbances in acute ischemic cerebral infarction

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Ischemic stroke is the most common neurological disease and the third most common cause of death in Germany.
Up to 35 % of ischemic strokes are caused by cardiac events.
Immediately after stroke – and during following years – there is an increased risk of cardiac complications such as myocardial infarction, sudden unexplained cardiac death or cardiac arrhythmias.
Several studies on centrally induced disturbances of cardiovascular modulation after stroke conclude that stroke-induced lesions within structures of the central autonomic network result in cardiovascular complications and arrhythmias.
Previous studies showed that cardiovascular autonomic dysfunction depend on stroke location, and -lateralisation.
So far it is unclear how autonomic disturbances change in the acute phase of cerebral infarction.
The aim of this project is therefore to study the dynamics of sympathetic and parasympathetic cardiovascular dysregulation during the first 3-4 days after stroke.
To answer this question we will continuously record blood pressure, oxygen saturation, heart and respiratory rates in patients with acute cerebral infarction. Afterwards we will calculate parameters of the sympathetic and parasympathetic cardiovascular modulation by means of spectral analysis. Measurements should be made at admission of patients, as well as on the 2nd, 3rd and 4th day after stroke.

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Brief Summary in Scientific Language

Ischemic stroke is the most common neurological disease and the third most common cause of death in Germany. Up to 35 % of ischemic strokes are caused by cardio-embolic events. Immediately after stroke – and during following years – there is an increased risk of cardiac complications such as myocardial infarction, sudden unexplained cardiac death or cardiac arrhythmias. Several studies on centrally induced disorders of cardiovascular modulation after stroke conclude that stroke-induced lesions within structures of the central network of the autonomic nervous system result in cardiovascular complications and arrhythmias.
According to the Northern Manhattan Stroke Study (NOMAS) the risk of myocardial infarction
or cardiac death is increased mainly after stroke within the frontal, parietal, temporal or
insular brain regions. Oppenheimer et al. showed that insular lesions are of major relevance for cardiac derangement and sudden death.
Analyzing the data of the NOMAS study, Rincon and co-workers demonstrated an increased risk of cardiac complications mainly in patients with lesions within the left or right parietal lobe.
Based on existing studies we assume that neuronal discharges in the stroke penumbra as well as absent activity from injured brain areas may cause impairment of sympathetic and parasympathetic cardiovascular modulation and thus induce arrhythmias and cardiac complications as well as further strokes.
However, so far it is unclear how autonomic disturbances change in the acute phase of cerebral infarction. Moreover, it is unclear whether there are correlations between the acute clinical deficit and autonomic dysfunction.
The aim of our study is therefore to assess the dynamics of sympathetic and parasympathetic cardiovascular dysregulation during the first 4 days after stroke.
To answer this question we will continuously record blood pressure, oxygen saturation, heart and respiratory rates in patients with acute cerebral infarction. Afterwards we will calculate parameters of the sympathetic and parasympathetic cardiovascular modulation by means of spectral analysis. Measurements will be made at admission of patients, as well as on the 2nd, 3rd and 4th day after stroke.
As part of the daily routine on the stroke-unit we will also assess the clinical deficit of the patients by means of the NIHSS-score.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00008931
  •   2015/07/20
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  •   yes
  •   Approved
  •   3859, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

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Health Condition or Problem studied

  •   I63.9 -  Cerebral infarction, unspecified
  •   healthy participants
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Interventions/Observational Groups

  •   patients with ischemic stroke - we will record heart rate, blood pressure, respiratory frequency, oxygen saturation within 24 hours after stroke onset, and on the 2nd, 3rd, and 4th day after stroke onset
  •   healthy participants - we will once only record heart rate, blood pressure, respiratory frequency, oxygen saturation
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

For this study, no end-points were defined. Aim of the study is to identify dynamics of sympathetic and parasympathetic cardiovascular dysregulation during the first 4 days after stroke in relation to the localization of the stroke.
For 5 minutes at supine rest we will continuosly record heart rate using
conventional three-lead electrocardiography. Beat-to-beat systolic and diastolic blood pressures will be monitored non-invasively at the index or middle finger of the non-paretic hand using the vascular unloading technique (CNAP™ -System, Dräger Medical, Deutschland). Respiratory frequency will be monitored by chest impedance measurements. Transcutaneous oxygen saturation will be measured by means of finger pulsoxymetry.
Zusätzlich wird mehrmals täglich im Rahmen der normalen Überwachung auf der Stroke-Unit der klinische Schweregrad mittels NIHSS-score bestimmt.
Additionaly, as part of the usual routine work on stroke-unit, clinical impairment by means of the NIHSS-score will be assessed.

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Secondary Outcome

For this study, no secondary end-points were defined

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2009/04/14
  •   100
  •   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

Patients with acute supratentorial ischemic stroke, who can be measured within 24 hours after stroke onset.

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Exclusion Criteria

Patients with a history of stroke, pre-existing cardiovascular disease, diabetes mellitus or
other disease or medication known to affect the autonomic nervous system are excluded
from the study. Patients with cardiac arrhythmias or pace-maker will also be excluded.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Neurologische Universitätsklinik Erlangen
    • Mr.  Prof. Dr. med. Dr. med. habil  Max J.  Hilz 
    • Schwabachanlage 6
    • 91054  Erlangen
    • Germany
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    • Neurologische Universitätsklinik Erlangen
    • Mr.  Prof. Dr. med. Dr. med. habil  Max J.  Hilz 
    • Schwabachanlage 6
    • 91054  Erlangen
    • Germany
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    • Neurologische Universitätsklinik Erlangen
    • Mr.  Prof. Dr. med. Dr. med. habil  Max J.  Hilz 
    • Schwabachanlage 6
    • 91054  Erlangen
    • Germany
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Sources of Monetary or Material Support

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    • Rolf und Hubertine Schiffbauer-Stiftung
    • Ms.  Maria Hubertine  Schiffbauer 
    • Dorfstr. 3
    • 95182  Döhlau
    • Germany
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    • Bayer Vital GmbH
    • Ms.  Dr.  Uschi  von der Osten 
    • Leisnerweg 35
    • 81929  München
    • Germany
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    • Neurologische Universitätsklinik Erlangen
    • Mr.  Prof. Dr. med. Dr. med. habil  Max J.  Hilz 
    • Schwabachanlage 6
    • 91054  Erlangen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2010/06/12
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Trial Publications, Results and other Documents

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