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

17. marts 2021 opdateret af: Helle Klingenberg Iversen

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Region Hovedstaden
      • Copenhagen, Region Hovedstaden, Danmark, 2100
        • Department of Neurology, Rigshospitalet

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

All patients who could be candidates for endovascular treatment in Region Zealand and The Capital Region of Denmark are assessed in Rigshospitalet, yearly around 200 patients. If endovascular treatment is attempted, subjects will be included. Only ischemic stroke patients with large-vessel occlusion will be eligible for endovascular treatment.

Only patients fulfilling the inclusion criteria and not the exclusion criteria are eligible. Patients will be enrolled before consent is given. Consent is obtained after endovascular treatment after oral and written information is provided. Recruitment is approved by Ethics Committee.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Oxygenated hemoglobin ratio of total hemoglobin before, during and after endovascular treatment
Tidsramme: 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
From onset of examination before EVT, during EVT and up to 2 hours after EVT.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Oxygenated hemoglobin ratio of total hemoglobin before and after endovascular treatment
Tidsramme: 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.
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.
Oxygenated hemoglobin before and after endovascular treatment
Tidsramme: 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
From onset of examination before EVT, during EVT and up to 2 hours after EVT.
Oxygenated hemoglobin before and after endovascular treatment
Tidsramme: 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.
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.
Independence assessed with modified Ranking Scale (mRS)
Tidsramme: 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.

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

Changes from just before EVT to 2 hours, 24 hours and 90 days after EVT
Composite vascular outcome of new events
Tidsramme: 90 days after EVT
New stroke or transitory cerebral ischemia, acute coronary syndrome or operation for peripheral artery disease.
90 days after EVT
Complications related to EVT
Tidsramme: 90 days after EVT
Any complications related to EVT 90 days after procedure.
90 days after EVT
Mortality
Tidsramme: 90 days after EVT
Death by cause at 90 days after EVT
90 days after EVT

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Ledende efterforsker: Helle K Iversen, DMSc, Department of Neurology, Rigshospitalet

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. november 2018

Primær færdiggørelse (Faktiske)

15. februar 2021

Studieafslutning (Faktiske)

15. februar 2021

Datoer for studieregistrering

Først indsendt

17. oktober 2018

Først indsendt, der opfyldte QC-kriterier

8. november 2018

Først opslået (Faktiske)

13. november 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. marts 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. marts 2021

Sidst verificeret

1. marts 2021

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • H-18028704 (Anden identifikator: Scientific Ethics Committee, The Capital Region of Denmark)
  • VD-2018-269 (I-suite: 6509) (Anden identifikator: Danish Data Protection Agency)

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