Trial document




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  DRKS00006564

Trial Description

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Title

Spatially-resolved assessment of cerebral autoregulation in patients with acute partial anterior circulation stroke

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The vascular system of the brain in healthy people is able to keep the brain perfusion constant within certain limits, independent of blood pressure. This ability is called cerebral autoregulation, it is however impaired in various diseases of the brain, such as stroke. It is not clear whether the disturbance of autoregulation is limited to the actual infarct area or whether adjacent regions are also affected. The study will attempt to examine the cerebral autoregulation using near-infrared spectroscopy. Laser light through the scalp and skull makes a measurement of the oxygen content of the blood within the brain possible without surgery.

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Brief Summary in Scientific Language

Cerebral autoregulation is a fast protective mechanism, which keeps the perfusion relatively independent from blood pressure. In various diseases, such as stenoses or occlusions of cerebral arteries cerebral autoregulation may be disturbed. Strokes can also lead to disruption of cerebral autoregulation. However, it is not known whether the initial disturbed area is restricted to the infarcted area, whether also the surrounding area is affected or the entire supplied area is concerned.
Transcranial Doppler sonography allows as a non-invasive method the recording of blood flow velocity and thus the cerebral autoregulation in the main stem of the middle cerebral artery.
Near-infrared spectroscopy (NIRS) can be used for temporal high resoluted measurement of oxy-and deoxyhemoglobin concentrations. A spatially resolved measurement of the hemodynamics with multi-channel NIRS equipment (52 measuring channels) is also possible in larger areas of the cerebral cortex.
Together with simultaneous blood pressure measurement, NIRS allows a non-invasive determination of cerebral autoregulation. To this end, spontaneous fluctuations in blood pressure, respiration-induced fluctuations and slight hypotension induced by thigh-cuff deflation are applied.
The aim of this pilot study is to show that a measurement of cerebral autoregulation from spontaneous fluctuations by NIRS is possible. On the other hand, we would like to examine the spatial distribution of autoregulation dysfunction in patients with unilateral middle cerebral artery stroke.

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Organizational Data

  •   DRKS00006564
  •   2014/11/06
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  •   yes
  •   Approved
  •   30/12_140765, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   I63 -  Cerebral infarction
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Interventions/Observational Groups

  •   In the first study arm patients aged between 18-85 years with unilateral Media infarction within the last 96-144 hrs are included who have given their consent for study participation and anonymous scientific use of the data. If there are not already current findings an MRI of the head with MP-Rage and diffusion weighting is performed to determine the localization of the infarction. All patients will be examined by ultrasound regarding the status of intra- and extracranial vessels and the collateral supply if not already current findings are available.
    The NIRS measurement is then carried out with the device ETG4000 (Hitachi Medical Corporation). The patient lies in bed or on a lounge chair. The blood pressure is measured non-invasively via a fingerplethysmograph. To carry out the near-infrared spectroscopy, a grid with 33 NIRS emitters and detectors (which allow the calculation of 52 channels) is placed over the forehead and temples of the patient by means of a rubber band. By means of electromagnetic waves the shape of the skull and the position of the optodes for future projection of the measurement results to the patients brain is set. The end-tidal CO2 concentration is detected by capnography throughout the NIRS study using a Datex-capnometer. Blood pressure cuffs for a subsequent induction of a rapid drop in blood pressure are wrapped around on both thighs.
    After detailed instruction of the patient and a resting phase with cardio- and cerebrovascular stabilization the spontaneous fluctuations of the NIRS signal over 30 minutes will be measured. Subsequently, the patient is instructed to breath shallowly over 200 seconds with a frequency of 0.1 Hz (this part of the experiment only if the patient is able to follow the instructions).
    Afterwards the thigh cuffs are inflated to 20 mmHg above the systolic blood pressure value of the patient and maintained on this level of pressure for 2 min. This is followed by rapid depressurization which should generate a systolic blood pressure drop by at least 10 mmHg. If this can not be achieved, the thigh cuff manoeuver will be repeated up to two times. The test may be terminated at the request of the patient at any time.
    For all existing 52 NIRS channels the correlation coefficient index (CCI) between mean ABP and NIRS signals HbTot, HbOx and HbRed is determinded for the period of spontaneous breathing. Tentatively also the correlation between systolic and diastolic ABP and the corresponding NIRS parameters is calculated. Using the data of metronomic breathing a crossed spectral analysis between ABP and the NIRS parameters is performed. In addition, it is examined whether the blood pressure drop induced by the thigh cuff test has an influence on the mentioned parameters.
  •   The second study arm includes healthy volunteers aged 18 to 85 years which are age and sex matched to the patients. The investigations carried out on the subjects are identical to the first study arm.
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Characteristics

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

The primary objective is the possibility of measurement of cerebral autoregulation from spontaneous fluctuations in blood pressure at the time of the study (96-144h after infarction). For each patient and experimentee the mean autoregulation parameters (correlation coefficient index (CCI) between mean ABP and NIRS signals, HbTot, hbox and HbRed [MxHbTot, MxHbOx, MxHbRed]) in all 52 channels are calculated. On the basis of these average values ​​we determine by means of a Wilcoxon-rank-sum-tests whether a separation of the groups and thus a measurement of the cerebral auto regulation is possible.

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Secondary Outcome

Secondary objective is the description of a spatial disturbance at the time of investigation (96-144 h after infarction). For each group (patients and control group) an average value of the autoregulation parameters in each of the 52 channels is calculated. Based on these mean values​​, then the Wilcoxon-rank-sum-test determines whether there is a deviation between the groups for each channel. In this way we can find out whether the disturbance of autoregulation is only present in a sub-region (i.e. single channel) or in larger areas.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/11/10
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   85   Years
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Additional Inclusion Criteria

Acute middle cerebral artery stroke 96-144 hours after onset

Informed consent in study participation and anonymous scientific use of data

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Exclusion Criteria

Missing cooperation
Peripheral arterial occlusive disease
Other acute ischemic stroke within he last 3 months
High-grade stenosis of internal carotid artery or middle cerebral artery (>50%)

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg/Neurologie
    • Mr.  Prof. Dr.  Matthias  Reinhard 
    • Breisacher Str. 64
    • 79114  Freiburg im Breisgau
    • Germany
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    • Universitätsklinikum FreiburgNeurologie
    • Mr.  Prof. Dr.  Matthias  Reinhard 
    • Breisacher Str. 64
    • 79114  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgNeurologie
    • Mr.  Dr.  Maximilian  Oeinck 
    • Breisacher Str. 64
    • 79114  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum FreiburgNeurologie
    • Mr.  Prof. Dr.  Matthias  Reinhard 
    • Breisacher Str. 64
    • 79114  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/07/24
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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.