StrokeNCT02705599
Stroke Mechanism Evolution in Intracranial Atherosclerotic Stenosis
An observational study of Stroke, run by Chinese PLA General Hospital at 2 sites in China.
Trial summary
Predictors of the risk of recurrent stroke for patients with symptomatic intracranial atherosclerotic stenosis (ICAS) remain unknown. The study will be to explore the stroke mechanism evolution in patients with ICAS by multi-model magnetic resonance imaging (MRI) which consists of diffusion-weighted imaging (DWI) and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 230 participants
- Where
- 2 sitesChina
- Study dates
- Aug 2014to Dec 2020
- 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: Symtomatic patients with intracranial atherosclerostic stenosis
Who may be able to join
None listed.
Who cannot join
- Non-atherosclerosis vasculopathy such as vasculitis and arterial dissection diagnosed by comprehensive laboratory work (such as erythrocyte sedimentation rate or C-reactive protein elevations, antinuclear antibody, or antiphospholipid antibody positivity), vascular imaging, and clinical evaluation;
- Contraindication to MR examination, medical instability precluding MR examination.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Beijing Tiantan Hospital
Beijing, 100853
About this study
Predictors of the risk of recurrent stroke for patients with symptomatic intracranial atherosclerotic stenosis (ICAS) remain unknown. The study will be to explore the stroke mechanism evolution in patients with ICAS by multi-model magnetic resonance imaging (MRI) which consists of diffusion-weighted imaging (DWI) and high-resolution MRI (HRMRI). The patients with symptomatic ICAS will undergo multi-model MRI. The baseline data, infarct patterns on DWI, and plaque features on HRMRI will be collected. The stroke mechanisms will be determined by the infarct patterns. During the 2 years follow-up, the recurrent ischemic events will be recorded. By comparing the baseline data, infarct patterns, and plaque features in patients with and without recurrent strokes, the high-risk features of patients with symptomatic ICAS will be identified. The evaluation of stroke mechanisms of patients with symptomatic ICAS will be summarized.
Read the detailed description
Objective:
Primary objective: to identify which plaque features on HRMRI in patients with symptomatic ICAS are related to recurrent stroke.
Secondary objectives: To compare plaque features in subgroups.
Patients enrollment please see Eligibility part.
Methods:
A 3T GE (DISCOVERY MR 750, GE Healthcare, Waukesha, WI, USA) and a 3T Siemens Trio MR scanner (Siemens Healthcare, Ehrlangen, Germany) will be used in this study. The multiple sequences will include 3D time of flight (TOF) MR angiography, 3D T1-weighted imaging, proton attenuation weighted imaging, magnetization-prepared rapid acquisition with gradient-echo sequence (MPRAGE), and contrast enhancement on T1-weighted imaging.
The parameters of multiple sequences on GE MR Scanner are followed. 3D TOF: repetition time (TR) = minimum, echo time (TE) = minimum; field of view (FOV) = 240×220 mm2, matrix = 288×192, slice thickness = 2 mm, flip angle (FA) = 20, and scan time = 1:53 minutes. 3D CUBE T1: TR = 600 ms, TE = minimum, FOV = 240×220 mm2, matrix = 480×480, slice thickness = 0.8 mm, FA = NA, and scan time = 3:33 minutes. 3D CUBE PD: TR = 1500 ms, TE = 40 ms, FOV = 240×220 mm2, matrix = 384×384, slice thickness = 0.8 mm, FA = NA, and scan time = 2:40 minutes. MP RAGE: TR = minimum, TE = 3.3 ms, FOV = 240×240 mm2, matrix = 256×256, slice thickness = 0.8 mm, FA = 12, and scan time = 2:18 minutes.
The parameters of multiple sequences on Siemens MR Scanner are followed. 3D TOF: TR= 24 ms, TE = 4.32 ms; FOV = 140×140 mm2, matrix = 256×256, slice thickness = 0.9 mm, FA = 18, and scan time = 2 min 14 s. 3D SPACE T1: TR = 800 ms, TE = 22 ms, FOV = 180×168 mm2, matrix = 256×251, slice thickness = 0.8 mm, FA = NA, and scan time = 4:4 minutes. 3D SPACE PD: TR = 1700 ms, TE = 23 ms, FOV = 180×180 mm2, matrix = 320×304, slice thickness = 0.6 mm, FA = NA, and scan time = 4:25 minutes. MP RAGE: TR = 776.13 ms, TE = 5.8 ms, FOV = 144×144 mm2, matrix = 240×240, slice thickness = 1 mm, FA = 15, and scan time = 2:39 minutes.
IMAGING EVALUATION In this study, plaques will be identified as focal or diffuse but eccentric wall thickenings compared with normal vessel wall.
Plaque composition will include hemorrhage and calcification. The anatomical location of plaque will be recorded as either one of the four quadrants of the vessel wall on cross-sectional images.
Plaque that is distributed across ≥3 quadrants of the lumen perimeter will be defined as diffuse and that involving ≤2 will be defined as focal.
In this study, enhancement analysis will include both grades and patterns. Enhancement will be classified into 3 different grades: non-enhancement, mild-moderate enhancement, and strong enhancement. Mild-moderate enhancement is defined as less than that of the pituitary infundibulum. Strong enhancement is equal to or stronger than that of the pituitary infundibulum. The pattern of enhancement will be categorized as focal, heterogeneous, or homogenous.
The vessel and wall areas at the maximal lumen narrowing (MLN) site will be measured. The plaque volume will be calculated as the product of the plaque area and the thickness of the slices containing the plaque. The plaque/wall ratio was defined as the plaque area divided by wall area ×100%. The remodeling index was calculated as the ratio of the vessel area at the MLN site to that at the reference site. The reference site was selected based on the Warfarin-Aspirin Symptomatic Intracranial Disease trial method.
STROKE MECHANISMS The stroke includes hypoperfusion, perforator (branch atheromatous disease), artery-to-artery embolism, or co-existing (combinations of these ischemic mechanisms).
FOLLOW-UP At the 2 years follow-up, patients were contacted monthly by phone to determine whether any events had occurred at the first year and three months at the second year. Every three months, patients were examined face-to-face by two neurologists at the first year and every six months at the second year. The follow-up information included transient ischemic attack and ischemic stroke (in any vascular territory), brain hemorrhage, and all-cause death. If these events but death suspected, patients underwent brain computed tomography or MR imaging.
- Conditions
- Stroke
- Keywords
- Ischemic stroke, High resolution MRI, Perfusion, Mechanism
- Medical subject headings
- Stroke, Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemic stroke event (in the stenotic vascular territory)
The primary outcome will include ischemic stroke (in the stenotic vascular territory) and vascular death.
Measured: To 2 years
Secondary outcomes (1)
Ischemic stroke event (in the non-stenotic vascular territory)
The second outcome will include ischemic stroke (in the non-stenotic vascular territory) , transient ischemic attack, brain hemorrhage, and all-cause death.
Measured: To 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startAug 2014
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Principal investigator, Xin Lou, Chinese PLA General Hospital
- Investigators
- Xin Lou, M.D. Ph.D., Principal investigator, Chinese PLA General HospitalNing Ma, M.D. Ph.D., Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705599
- Sponsor's protocol ID
- HRMRI-NM-Tiantan
- Status last verified
- Apr 2023
- First submitted
- 7 Mar 2016
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lyu J, Ma N, Liebeskind DS, Wang DJ, Ma L, Xu Y, Wang T, Miao Z, Lou X. Arterial Spin Labeling Magnetic Resonance Imaging Estimation of Antegrade and Collateral Flow in Unilateral Middle Cerebral Artery Stenosis. Stroke. 2016 Feb;47(2):428-33. doi: 10.1161/STROKEAHA.115.011057. Epub 2016 Jan 5.
PubMed 26732570Ma N, Jiang WJ, Lou X, Ma L, Du B, Cai JF, Zhao TQ. Arterial remodeling of advanced basilar atherosclerosis: a 3-tesla MRI study. Neurology. 2010 Jul 20;75(3):253-8. doi: 10.1212/WNL.0b013e3181e8e714.
PubMed 20644151Lopez-Cancio E, Matheus MG, Romano JG, Liebeskind DS, Prabhakaran S, Turan TN, Cotsonis GA, Lynn MJ, Rumboldt Z, Chimowitz MI. Infarct patterns, collaterals and likely causative mechanisms of stroke in symptomatic intracranial atherosclerosis. Cerebrovasc Dis. 2014;37(6):417-22. doi: 10.1159/000362922. Epub 2014 Jul 4.
PubMed 25011483Hou Z, Li M, Lyu J, Xu Z, Liu Y, He J, Jing J, Wang R, Wang Y, Lou X, Miao Z, Ma N. Intraplaque Enhancement Is Associated With Artery-to-Artery Embolism in Symptomatic Vertebrobasilar Atherosclerotic Diseases. Front Neurol. 2021 Sep 1;12:680827. doi: 10.3389/fneur.2021.680827. eCollection 2021.
PubMed 34539546Yang M, Ma N, Liu L, Wang A, Jing J, Hou Z, Liu Y, Lou X, Miao Z, Wang Y. Intracranial collaterals and arterial wall features in severe symptomatic vertebrobasilar stenosis. Neurol Res. 2020 Aug;42(8):649-656. doi: 10.1080/01616412.2020.1782081. Epub 2020 Jun 23.
PubMed 32573371Xu Z, Li M, Lyu J, Hou Z, He J, Mo D, Gao F, Liu X, Sui B, Shen M, Pan Y, Wang Y, Lou X, Miao Z, Luo B, Ma N. Different risk factors in identical features of intracranial atherosclerosis plaques in the posterior and anterior circulation in high-resolution MRI. Ther Adv Neurol Disord. 2020 Mar 13;13:1756286420909991. doi: 10.1177/1756286420909991. eCollection 2020.
PubMed 32206091Xu Z, Li M, Hou Z, Lyu J, Zhang N, Lou X, Miao Z, Ma N. Association between basilar artery configuration and Vessel Wall features: a prospective high-resolution magnetic resonance imaging study. BMC Med Imaging. 2019 Dec 26;19(1):99. doi: 10.1186/s12880-019-0388-3.
PubMed 31878890Ma N, Xu Z, Lyu J, Li M, Hou Z, Liu Y, Yang M, Mo D, Gao F, Song L, Sun X, Liu L, Liu X, Sui B, Shen M, Ma L, Wang Y, Wang Y, Miao Z, Lou X. Association of Perforator Stroke After Basilar Artery Stenting With Negative Remodeling. Stroke. 2019 Mar;50(3):745-749. doi: 10.1161/STROKEAHA.118.023838.
PubMed 30661491
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Mechanism Evolution in Intracranial Atherosclerotic Stenosis
- ClinicalTrials.gov ID
- NCT02705599
- Acronym / sponsor ID
- HRMRI-NM-Tiantan
- Conditions
- Stroke
- Keywords
- Ischemic stroke, High resolution MRI, Perfusion, Mechanism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Study start
- Aug 2014 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 10 Mar 2016 (estimated)
- 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.
Predictors of the risk of recurrent stroke for patients with symptomatic intracranial atherosclerotic stenosis (ICAS) remain unknown. The study will be to explore the stroke mechanism evolution in patients with ICAS by multi-model magnetic resonance imaging (MRI) which consists of diffusion-weighted imaging (DWI) and high-resolution MRI (HRMRI). The patients with symptomatic ICAS will undergo multi-model MRI. The baseline data, infarct patterns on DWI, and plaque features on HRMRI will be collected. The stroke mechanisms will be determined by the infarct patterns. During the 2 years follow-up, the recurrent ischemic events will be recorded. By comparing the baseline data, infarct patterns, and plaque features in patients with and without recurrent strokes, the high-risk features of patients with symptomatic ICAS will be identified. The evaluation of stroke mechanisms of patients with symptomatic ICAS will be summarized.
Detailed description
Objective:
Primary objective: to identify which plaque features on HRMRI in patients with symptomatic ICAS are related to recurrent stroke.
Secondary objectives: To compare plaque features in subgroups.
Patients enrollment please see Eligibility part.
Methods:
A 3T GE (DISCOVERY MR 750, GE Healthcare, Waukesha, WI, USA) and a 3T Siemens Trio MR scanner (Siemens Healthcare, Ehrlangen, Germany) will be used in this study. The multiple sequences will include 3D time of flight (TOF) MR angiography, 3D T1-weighted imaging, proton attenuation weighted imaging, magnetization-prepared rapid acquisition with gradient-echo sequence (MPRAGE), and contrast enhancement on T1-weighted imaging.
The parameters of multiple sequences on GE MR Scanner are followed. 3D TOF: repetition time (TR) = minimum, echo time (TE) = minimum; field of view (FOV) = 240×220 mm2, matrix = 288×192, slice thickness = 2 mm, flip angle (FA) = 20, and scan time = 1:53 minutes. 3D CUBE T1: TR = 600 ms, TE = minimum, FOV = 240×220 mm2, matrix = 480×480, slice thickness = 0.8 mm, FA = NA, and scan time = 3:33 minutes. 3D CUBE PD: TR = 1500 ms, TE = 40 ms, FOV = 240×220 mm2, matrix = 384×384, slice thickness = 0.8 mm, FA = NA, and scan time = 2:40 minutes. MP RAGE: TR = minimum, TE = 3.3 ms, FOV = 240×240 mm2, matrix = 256×256, slice thickness = 0.8 mm, FA = 12, and scan time = 2:18 minutes.
The parameters of multiple sequences on Siemens MR Scanner are followed. 3D TOF: TR= 24 ms, TE = 4.32 ms; FOV = 140×140 mm2, matrix = 256×256, slice thickness = 0.9 mm, FA = 18, and scan time = 2 min 14 s. 3D SPACE T1: TR = 800 ms, TE = 22 ms, FOV = 180×168 mm2, matrix = 256×251, slice thickness = 0.8 mm, FA = NA, and scan time = 4:4 minutes. 3D SPACE PD: TR = 1700 ms, TE = 23 ms, FOV = 180×180 mm2, matrix = 320×304, slice thickness = 0.6 mm, FA = NA, and scan time = 4:25 minutes. MP RAGE: TR = 776.13 ms, TE = 5.8 ms, FOV = 144×144 mm2, matrix = 240×240, slice thickness = 1 mm, FA = 15, and scan time = 2:39 minutes.
IMAGING EVALUATION In this study, plaques will be identified as focal or diffuse but eccentric wall thickenings compared with normal vessel wall.
Plaque composition will include hemorrhage and calcification. The anatomical location of plaque will be recorded as either one of the four quadrants of the vessel wall on cross-sectional images.
Plaque that is distributed across ≥3 quadrants of the lumen perimeter will be defined as diffuse and that involving ≤2 will be defined as focal.
In this study, enhancement analysis will include both grades and patterns. Enhancement will be classified into 3 different grades: non-enhancement, mild-moderate enhancement, and strong enhancement. Mild-moderate enhancement is defined as less than that of the pituitary infundibulum. Strong enhancement is equal to or stronger than that of the pituitary infundibulum. The pattern of enhancement will be categorized as focal, heterogeneous, or homogenous.
The vessel and wall areas at the maximal lumen narrowing (MLN) site will be measured. The plaque volume will be calculated as the product of the plaque area and the thickness of the slices containing the plaque. The plaque/wall ratio was defined as the plaque area divided by wall area ×100%. The remodeling index was calculated as the ratio of the vessel area at the MLN site to that at the reference site. The reference site was selected based on the Warfarin-Aspirin Symptomatic Intracranial Disease trial method.
STROKE MECHANISMS The stroke includes hypoperfusion, perforator (branch atheromatous disease), artery-to-artery embolism, or co-existing (combinations of these ischemic mechanisms).
FOLLOW-UP At the 2 years follow-up, patients were contacted monthly by phone to determine whether any events had occurred at the first year and three months at the second year. Every three months, patients were examined face-to-face by two neurologists at the first year and every six months at the second year. The follow-up information included transient ischemic attack and ischemic stroke (in any vascular territory), brain hemorrhage, and all-cause death. If these events but death suspected, patients underwent brain computed tomography or MR imaging.
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
- Symtomatic patients with intracranial atherosclerostic stenosis
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Non-atherosclerosis vasculopathy such as vasculitis and arterial dissection diagnosed by comprehensive laboratory work (such as erythrocyte sedimentation rate or C-reactive protein elevations, antinuclear antibody, or antiphospholipid antibody positivity), vascular imaging, and clinical evaluation;
- Contraindication to MR examination, medical instability precluding MR examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ischemic stroke event (in the stenotic vascular territory)
Time frame: To 2 years
The primary outcome will include ischemic stroke (in the stenotic vascular territory) and vascular death.
1 secondary outcome
Ischemic stroke event (in the non-stenotic vascular territory)
Time frame: To 2 years
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 4 Apr 2023.
- Background: PubMed 26732570Lyu J, Ma N, Liebeskind DS, Wang DJ, Ma L, Xu Y, Wang T, Miao Z, Lou X. Arterial Spin Labeling Magnetic Resonance Imaging Estimation of Antegrade and Collateral Flow in Unilateral Middle Cerebral Artery Stenosis. Stroke. 2016 Feb;47(2):428-33. doi: 10.1161/STROKEAHA.115.011057. Epub 2016 Jan 5.
- Background: PubMed 20644151Ma N, Jiang WJ, Lou X, Ma L, Du B, Cai JF, Zhao TQ. Arterial remodeling of advanced basilar atherosclerosis: a 3-tesla MRI study. Neurology. 2010 Jul 20;75(3):253-8. doi: 10.1212/WNL.0b013e3181e8e714.
- Background: PubMed 25011483Lopez-Cancio E, Matheus MG, Romano JG, Liebeskind DS, Prabhakaran S, Turan TN, Cotsonis GA, Lynn MJ, Rumboldt Z, Chimowitz MI. Infarct patterns, collaterals and likely causative mechanisms of stroke in symptomatic intracranial atherosclerosis. Cerebrovasc Dis. 2014;37(6):417-22. doi: 10.1159/000362922. Epub 2014 Jul 4.
- Derived from this study: PubMed 34539546Hou Z, Li M, Lyu J, Xu Z, Liu Y, He J, Jing J, Wang R, Wang Y, Lou X, Miao Z, Ma N. Intraplaque Enhancement Is Associated With Artery-to-Artery Embolism in Symptomatic Vertebrobasilar Atherosclerotic Diseases. Front Neurol. 2021 Sep 1;12:680827. doi: 10.3389/fneur.2021.680827. eCollection 2021.
- Derived from this study: PubMed 32573371Yang M, Ma N, Liu L, Wang A, Jing J, Hou Z, Liu Y, Lou X, Miao Z, Wang Y. Intracranial collaterals and arterial wall features in severe symptomatic vertebrobasilar stenosis. Neurol Res. 2020 Aug;42(8):649-656. doi: 10.1080/01616412.2020.1782081. Epub 2020 Jun 23.
- Derived from this study: PubMed 32206091Xu Z, Li M, Lyu J, Hou Z, He J, Mo D, Gao F, Liu X, Sui B, Shen M, Pan Y, Wang Y, Lou X, Miao Z, Luo B, Ma N. Different risk factors in identical features of intracranial atherosclerosis plaques in the posterior and anterior circulation in high-resolution MRI. Ther Adv Neurol Disord. 2020 Mar 13;13:1756286420909991. doi: 10.1177/1756286420909991. eCollection 2020.
- Derived from this study: PubMed 31878890Xu Z, Li M, Hou Z, Lyu J, Zhang N, Lou X, Miao Z, Ma N. Association between basilar artery configuration and Vessel Wall features: a prospective high-resolution magnetic resonance imaging study. BMC Med Imaging. 2019 Dec 26;19(1):99. doi: 10.1186/s12880-019-0388-3.
- Derived from this study: PubMed 30661491Ma N, Xu Z, Lyu J, Li M, Hou Z, Liu Y, Yang M, Mo D, Gao F, Song L, Sun X, Liu L, Liu X, Sui B, Shen M, Ma L, Wang Y, Wang Y, Miao Z, Lou X. Association of Perforator Stroke After Basilar Artery Stenting With Negative Remodeling. Stroke. 2019 Mar;50(3):745-749. doi: 10.1161/STROKEAHA.118.023838.
- Individual participant dataSharing planned: No
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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.
Xin Lou, M.D. Ph.D. principal investigator
Chinese PLA General Hospital
Ning Ma, M.D. Ph.D. principal investigator
Beijing Tiantan Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Chinese PLA General Hospital at 2 sites in China.
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 0 inclusion and 2 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 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Ischemic stroke event (in the stenotic vascular territory) (time frame: To 2 years). 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 NCT02705599, which also lists 8 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 4 Apr 2023.