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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03738644
Enrollment
100
Registered
2018-11-13
Start date
2018-11-20
Completion date
2021-02-15
Last updated
2021-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

Endovascular treatment, Near-infrared spectroscopy, Intra-operational monitoring

Brief summary

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.

Detailed description

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.

Interventions

OTHERMonitoring with near-infrared spectroscopy

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.

Sponsors

Helle Klingenberg Iversen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Oxygenated hemoglobin ratio of total hemoglobin before, during and after endovascular treatmentFrom 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

MeasureTime frameDescription
Oxygenated hemoglobin before and after endovascular treatmentFrom 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
Independence assessed with modified Ranking Scale (mRS)90 days after EVTmRS 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.
Degree of disabilities assessed by National Institute of Health Stroke Scale (NIHSS)Changes from just before EVT to 2 hours, 24 hours and 90 days after EVTChanges 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.
Oxygenated hemoglobin ratio of total hemoglobin before and after endovascular treatmentBaseline 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.
Complications related to EVT90 days after EVTAny complications related to EVT 90 days after procedure.
Mortality90 days after EVTDeath by cause at 90 days after EVT
Composite vascular outcome of new events90 days after EVTNew stroke or transitory cerebral ischemia, acute coronary syndrome or operation for peripheral artery disease.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026