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Completed

NCT Number: NCT03738644

Monitoring Stroke Patients With Near-infrared Spectroscopy Before, During and After Endovascular Treatment

The purpose of this study is to examine the hemodynamics of stroke patients with near-infrared spectroscopy before, during and after endovascular treatment and their relations to disabilities and mortality 3 months after treatment.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology, Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

About this study

Endovascular treatment is the revascularization after ischemic stroke due to large-artery occlusion by mechanical removal of thrombi with an intraarterial catheter. The area around the infarction called the penumbra, which has partial blood supply by collateral vessels, can thereby be salvaged and the neuronal function restored. EVT lowers the disabilities and the morbidity if it is performed within 6 hours of onset or within 24 hours in stroke patients with a significant penumbra (Rodrigues, Neves et al. 2016).

However, complications can arise during EVT including critically failing CBF, intracranial hemorrhage and embolization of the thrombus to more peripheral vessels, which can all result in further brain damage.

To avoid these repercussions or detect them as fast as possible as well as detecting successful interventions, a suitable method for monitoring CBF over time is needed. NIRS is a commonly applied method that examines CBF in the cerebral cortex, which has already been used as intraoperative monitoring during abdominal and cardiac surgery (Yu, Zhang et al. 2018), but only in minor studies of EVT patients, where results have been very promising and associated to long-term outcomes (Hametner, Stanarcevic et al. 2015, Ritzenthaler, Cho et al. 2017). NIRS exploits that absorption of infrared light is only changed by hemoglobin, which can therefore by measured over time. NIRS is a non-invasive and safe method that measures oxygenated and deoxygenated hemoglobin in the cerebral cortex (Ferrari and Quaresima 2012).

Cerebral autoregulation (CA) is a complex mechanism that maintains an relatively constant and adequate CBF, which is often impaired in acute stroke patients (Paulson, Strandgaard et al. 1990). The nature of CA can be examined with NIRS (Obrig, Neufang et al. 2000, Reinhard, Wehrle-Wieland et al. 2006, Schytz, Hansson et al. 2010, Zweifel, Dias et al. 2014) and impairment can be shown (Li, Wang et al. 2010, Han, Li et al. 2014, Han, Zhang et al. 2014, Phillip and Schytz 2014). NIRS examinations of CA has never been done during EVT and the relation between changes in CA and patient outcome remains unknown.

This leads to the following hypothesis:

  • CBF and CA can be monitored with NIRS before, during and after EVT and detect complications and successful EVTs.
  • CBF and CA during and after EVT can be associated to the disabilities and mortality of stroke patients 3 months after the treatment.

The investigators will examine stroke patients who receive EVT with NIRS. The equipment will be placed on participants forehead when they arrive to the department and monitored for up to 2 hours after EVT. A 20-minute follow-up NIRS examinations will be done at 24 hours and 3 months after EVT. National Institute of Health Stroke Scale (NIHSS) will be performed before and after EVT, at 24 hours and 3 months after EVT. Participants will be assessed for functioning level and scored for independence with Modified Ranking Scale and screened for new vascular events, complications related to EVT and death by cause after 3 months.

To satisfy power calculations, 100 patients will be enrolled in the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stroke patients receiving endovascular treatment

Exclusion criteria

  • Premorbid mRS > 3
  • Acute EEG examinations within 2 hours after EVT
  • Neurosurgical evacuation within 2 hours after EVT
  • Remaining life expectancy < 90 days

Treatment and study plan

Monitoring with near-infrared spectroscopy

Other

No interventions are used. Stroke patients are examined with near-infrared spectroscopy (NIRS). NIRS examinations are done with Octamon system (Artinis Medical Systems, Elst, The Netherlands) consisting of 8 transmitters emitting infrared light of 760 and 850 nm and 2 receivers measuring oxygenated and deoxygenated hemoglobin in the frontal cortex.

Examination protocol can be found in detailed description.

Primary outcomes

  1. Oxygenated hemoglobin ratio of total hemoglobin before, during and after endovascular treatment

    Time frame: From onset of examination before EVT, during EVT and up to 2 hours after EVT.

    Variability in oxygenated hemoglobin from onset of examination before EVT until end of examination up to 2 hours after EVT

Other outcomes

  1. Oxygenated hemoglobin ratio of total hemoglobin before and after endovascular treatment

    Time frame: Baseline before EVT is initiated, last part of monitoring period (up to 2 hours) after EVT and 20 min. recordings 24 hours and 90 days after EVT.

    Changes in oxygenated hemoglobin ratio of total hemoglobin from baseline (before EVT) to last part of monitoring period (up to 2 hours) and to 20 min. recordings at 24 hours and 90 days.

  2. Oxygenated hemoglobin before and after endovascular treatment

    Time frame: From onset of examination before EVT, during EVT and up to 2 hours after EVT.

    Variability in oxygenated hemoglobin from onset of examination before EVT until end of examination up to 2 hours after EVT

  3. Oxygenated hemoglobin before and after endovascular treatment

    Time frame: Baseline before EVT is initiated, last part of monitoring period (up to 2 hours) after EVT and 20 min. recordings 24 hours and 90 days after EVT.

    Changes from baseline (before EVT) to last part of monitoring period (up to 2 hours) and to 20 min. recordings at 24 hours and 90 days.

  4. Independence assessed with modified Ranking Scale (mRS)

    Time frame: 90 days after EVT

    mRS 90 days after EVT. The mRS scale runs from 0-6, running from perfect health without symptoms (score of 0) to death (score of 6).

    0 - No symptoms.

    • - No significant disability. Able to carry out all usual activities, despite some symptoms.
    • - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    • - Moderate disability. Requires some help, but able to walk unassisted.
    • - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    • - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    • - Dead.
  5. Degree of disabilities assessed by National Institute of Health Stroke Scale (NIHSS)

    Time frame: Changes from just before EVT to 2 hours, 24 hours and 90 days after EVT

    Changes is NIHSS from before EVT to after EVT.

    National Health Institute Stroke Scale (NIHSS): Stroke symptom severity scale with a range of 0-42. Higher score means more severe stroke symptoms.

  6. Composite vascular outcome of new events

    Time frame: 90 days after EVT

    New stroke or transitory cerebral ischemia, acute coronary syndrome or operation for peripheral artery disease.

  7. Complications related to EVT

    Time frame: 90 days after EVT

    Any complications related to EVT 90 days after procedure.

  8. Mortality

    Time frame: 90 days after EVT

    Death by cause at 90 days after EVT

Sponsors and collaborators

Lead sponsor

Helle Klingenberg Iversen

Other

Registry information

Official study title

Near-infrared Spectroscopy in Endovascular Treatment (Danish: Nær-infrarød Spektroskopi Ved endovaskulær Trombektomi)

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 13, 2018
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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