Monitoring Stroke Patients With Near-infrared Spectroscopy Before, During and After Endovascular Treatment
NCT ID: NCT03738644
Last Updated: 2021-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
100 participants
OBSERVATIONAL
2018-11-20
2021-02-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Effectiveness of Thrombolytic Therapy in Acute Ischemic Stroke Patients Using NIRS
NCT03621917
Mild Hypothermia After Endovascular Treatment in Acute Ischemic Stroke
NCT02985060
Evaluation of Treated and Untreated Stroke
NCT00001840
Acute Stroke Thrombectomy: Does CT Perfusion Accurately Predict Infarct on MRI After Recanalization
NCT02988492
Blod Biomarkers for Stroke
NCT03941249
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Monitoring 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Acute EEG examinations within 2 hours after EVT
* Neurosurgical evacuation within 2 hours after EVT
* Remaining life expectancy \< 90 days
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Helle Klingenberg Iversen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Helle Klingenberg Iversen
Senior neurologist, Head of Stroke Unit, Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Helle K Iversen, DMSc
Role: PRINCIPAL_INVESTIGATOR
Department of Neurology, Rigshospitalet
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Neurology, Rigshospitalet
Copenhagen, Capital Region, Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Heiberg AV, Lukassen TG, Truelsen TC, Borgwardt HG, Benndorf G, Solling C, Schytz HW, Moller K, Hansen K, Iversen HK. Dynamic cerebral autoregulation during and 3 months after endovascular treatment in large vessel occlusion stroke. Sci Rep. 2025 Aug 19;15(1):30289. doi: 10.1038/s41598-025-14672-y.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H-18028704
Identifier Type: OTHER
Identifier Source: secondary_id
VD-2018-269 (I-suite: 6509)
Identifier Type: OTHER
Identifier Source: secondary_id
H-18028704
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.