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

17. mars 2021 oppdatert av: 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.

Studieoversikt

Status

Fullført

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

100

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Helle K Iversen, DMSc, Department of Neurology, Rigshospitalet

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

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Studer hoveddatoer

Studiestart (Faktiske)

20. november 2018

Primær fullføring (Faktiske)

15. februar 2021

Studiet fullført (Faktiske)

15. februar 2021

Datoer for studieregistrering

Først innsendt

17. oktober 2018

Først innsendt som oppfylte QC-kriteriene

8. november 2018

Først lagt ut (Faktiske)

13. november 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. mars 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. mars 2021

Sist bekreftet

1. mars 2021

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

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UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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