Ischemic StrokeNCT03738644
Monitoring Stroke Patients With Near-infrared Spectroscopy Before, During and After Endovascular Treatment
An observational study of Ischemic Stroke, run by Helle Klingenberg Iversen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Monitoring with near-infrared spectroscopy
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Nov 2018to 15 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Stroke patients receiving endovascular treatment
Who cannot join
- Premorbid mRS > 3
- Acute EEG examinations within 2 hours after EVT
- Neurosurgical evacuation within 2 hours after EVT
- Remaining life expectancy < 90 days
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Neurology, Rigshospitalet
Copenhagen, Capital Region, 2100
About this study
Official title: 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.
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- Monitoring with near-infrared spectroscopy
- Keywords
- Endovascular treatment, Near-infrared spectroscopy, Intra-operational monitoring
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring with near-infrared spectroscopyOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenated hemoglobin ratio of total hemoglobin before, during and after endovascular treatment
Variability in oxygenated hemoglobin from onset of examination before EVT until end of examination up to 2 hours after EVT
Measured: From onset of examination before EVT, during EVT and up to 2 hours after EVT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start20 Nov 2018
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helle Klingenberg Iversen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Helle Klingenberg Iversen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Helle K Iversen, DMSc, Principal investigator, Department of Neurology, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738644
- Sponsor's protocol ID
- H-18028704
- Other IDs
- H-18028704, VD-2018-269 (I-suite: 6509)
- Status last verified
- Mar 2021
- First submitted
- 17 Oct 2018
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26243709Ritzenthaler 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.
PubMed 29089454Ferrari 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.
PubMed 22510258Paulson OB, Strandgaard S, Edvinsson L. Cerebral autoregulation. Cerebrovasc Brain Metab Rev. 1990 Summer;2(2):161-92.
PubMed 2201348Obrig 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.
PubMed 11112395Reinhard 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.
PubMed 17011584Schytz 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.
PubMed 20864356Zweifel 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.
PubMed 24703503Han 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.
PubMed 25281981Han 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.
PubMed 25117487Li 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.
PubMed 20156461Phillip, 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.
PubMed 27091337Yu 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.
PubMed 29341066Heiberg 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.
PubMed 40830559
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-infrared Spectroscopy in Endovascular Treatment (Danish: Nær-infrarød Spektroskopi Ved endovaskulær Trombektomi)
- ClinicalTrials.gov ID
- NCT03738644
- Acronym / sponsor ID
- H-18028704
- Conditions
- Ischemic Stroke
- Keywords
- Endovascular treatment, Near-infrared spectroscopy, Intra-operational monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Helle Klingenberg IversenUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Stroke patients receiving endovascular treatment
Key exclusion criteria (4 listed)
- Premorbid mRS > 3
- Acute EEG examinations within 2 hours after EVT
- Neurosurgical evacuation within 2 hours after EVT
- Remaining life expectancy < 90 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring with near-infrared spectroscopyNo 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. | Other | – |
Primary outcome
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.
Variability in oxygenated hemoglobin from onset of examination before EVT until end of examination up to 2 hours after EVT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Background: PubMed 26243709Hametner 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.
- Background: PubMed 29089454Ritzenthaler 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.
- Background: PubMed 22510258Ferrari 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.
- Background: PubMed 2201348Paulson OB, Strandgaard S, Edvinsson L. Cerebral autoregulation. Cerebrovasc Brain Metab Rev. 1990 Summer;2(2):161-92.
- Background: PubMed 11112395Obrig 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.
- Background: PubMed 17011584Reinhard 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.
- Background: PubMed 20864356Schytz 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.
- Background: PubMed 24703503Zweifel 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.
- Background: PubMed 25281981Han 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.
- Background: PubMed 25117487Han 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.
- Background: PubMed 20156461Li 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.
- BackgroundPhillip, 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).
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helle K Iversen, DMSc principal investigator
Department of Neurology, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Helle Klingenberg Iversen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03738644, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.