- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03738644
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)
Study Overview
Status
Conditions
Intervention / 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Region Hovedstaden
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Copenhagen, Region Hovedstaden, Denmark, 2100
- Department of Neurology, Rigshospitalet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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.
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Variability in oxygenated hemoglobin from onset of examination before EVT until end of examination up to 2 hours after EVT
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From onset of examination before EVT, during EVT and up to 2 hours after EVT.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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
Time Frame: From onset of examination before EVT, during EVT and up to 2 hours after EVT.
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Variability in oxygenated hemoglobin from onset of examination before EVT until end of examination up to 2 hours after EVT
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From onset of examination before EVT, during EVT and up to 2 hours after EVT.
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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.
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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.
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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.
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90 days after EVT
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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
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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
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Composite vascular outcome of new events
Time Frame: 90 days after EVT
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New stroke or transitory cerebral ischemia, acute coronary syndrome or operation for peripheral artery disease.
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90 days after EVT
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Complications related to EVT
Time Frame: 90 days after EVT
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Any complications related to EVT 90 days after procedure.
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90 days after EVT
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Mortality
Time Frame: 90 days after EVT
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Death by cause at 90 days after EVT
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90 days after EVT
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Helle K Iversen, DMSc, Department of Neurology, Rigshospitalet
Publications and helpful links
General Publications
- Ferrari M, Quaresima V. A brief review on the history of human functional near-infrared spectroscopy (fNIRS) development and fields of application. Neuroimage. 2012 Nov 1;63(2):921-35. doi: 10.1016/j.neuroimage.2012.03.049. Epub 2012 Mar 28.
- Schytz HW, Hansson A, Phillip D, Selb J, Boas DA, Iversen HK, Ashina M. Spontaneous low-frequency oscillations in cerebral vessels: applications in carotid artery disease and ischemic stroke. J Stroke Cerebrovasc Dis. 2010 Nov-Dec;19(6):465-74. doi: 10.1016/j.jstrokecerebrovasdis.2010.06.001.
- Zweifel C, Dias C, Smielewski P, Czosnyka M. Continuous time-domain monitoring of cerebral autoregulation in neurocritical care. Med Eng Phys. 2014 May;36(5):638-45. doi: 10.1016/j.medengphy.2014.03.002. Epub 2014 Apr 1.
- Hametner C, Stanarcevic P, Stampfl S, Rohde S, Veltkamp R, Bosel J. Noninvasive cerebral oximetry during endovascular therapy for acute ischemic stroke: an observational study. J Cereb Blood Flow Metab. 2015 Nov;35(11):1722-8. doi: 10.1038/jcbfm.2015.181. Epub 2015 Aug 5.
- Ritzenthaler T, Cho TH, Mechtouff L, Ong E, Turjman F, Robinson P, Berthezene Y, Nighoghossian N. Cerebral Near-Infrared Spectroscopy: A Potential Approach for Thrombectomy Monitoring. Stroke. 2017 Dec;48(12):3390-3392. doi: 10.1161/STROKEAHA.117.019176. Epub 2017 Oct 31.
- Paulson OB, Strandgaard S, Edvinsson L. Cerebral autoregulation. Cerebrovasc Brain Metab Rev. 1990 Summer;2(2):161-92.
- Obrig H, Neufang M, Wenzel R, Kohl M, Steinbrink J, Einhaupl K, Villringer A. Spontaneous low frequency oscillations of cerebral hemodynamics and metabolism in human adults. Neuroimage. 2000 Dec;12(6):623-39. doi: 10.1006/nimg.2000.0657.
- Reinhard M, Wehrle-Wieland E, Grabiak D, Roth M, Guschlbauer B, Timmer J, Weiller C, Hetzel A. Oscillatory cerebral hemodynamics--the macro- vs. microvascular level. J Neurol Sci. 2006 Dec 1;250(1-2):103-9. doi: 10.1016/j.jns.2006.07.011. Epub 2006 Oct 2.
- Han Q, Li Z, Gao Y, Li W, Xin Q, Tan Q, Zhang M, Zhang Y. Phase synchronization analysis of prefrontal tissue oxyhemoglobin oscillations in elderly subjects with cerebral infarction. Med Phys. 2014 Oct;41(10):102702. doi: 10.1118/1.4896113.
- Han Q, Zhang M, Li W, Gao Y, Xin Q, Wang Y, Li Z. Wavelet coherence analysis of prefrontal tissue oxyhaemoglobin signals as measured using near-infrared spectroscopy in elderly subjects with cerebral infarction. Microvasc Res. 2014 Sep;95:108-15. doi: 10.1016/j.mvr.2014.08.001. Epub 2014 Aug 10.
- Li Z, Wang Y, Li Y, Wang Y, Li J, Zhang L. Wavelet analysis of cerebral oxygenation signal measured by near infrared spectroscopy in subjects with cerebral infarction. Microvasc Res. 2010 Jul;80(1):142-7. doi: 10.1016/j.mvr.2010.02.004. Epub 2010 Feb 13.
- Phillip, D. and H.W. Schytz, Spontaneous Low Frequency Oscillations in Acute Ischemic Stroke ? A Near Infrared Spectroscopy (NIRS) Study. Journal of Neurology & Neurophysiology, 2014. 05(06).
- Rodrigues FB, Neves JB, Caldeira D, Ferro JM, Ferreira JJ, Costa J. Endovascular treatment versus medical care alone for ischaemic stroke: systematic review and meta-analysis. BMJ. 2016 Apr 18;353:i1754. doi: 10.1136/bmj.i1754.
- Yu Y, Zhang K, Zhang L, Zong H, Meng L, Han R. Cerebral near-infrared spectroscopy (NIRS) for perioperative monitoring of brain oxygenation in children and adults. Cochrane Database Syst Rev. 2018 Jan 17;1(1):CD010947. doi: 10.1002/14651858.CD010947.pub2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-18028704 (Other Identifier: Scientific Ethics Committee, The Capital Region of Denmark)
- VD-2018-269 (I-suite: 6509) (Other Identifier: Danish Data Protection Agency)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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