Silent StrokeACCURATE-1NCT04457908
The Effectiveness and Cost Effectiveness of Intelligent Assessment of Gait Disorder in Silent Cerebrovascular Disease
A study testing intelligent assessment in people with Silent Stroke, run by Shanghai Zhongshan Hospital.
Trial summary
This is a multi-center, randomized, double-blind, parallel-controlled, prospective study to compare the effectiveness and cost-effectiveness of intelligent and doctor groups for gait disorder screening. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Silent Stroke
- What is being tested?
- intelligent assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 31 Dec 2020
- Phase
- Interventional
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 60 and 85 years.
- Diagnosed with silent cerebrovascular disease/silent stroke, which is consistent with the 2016 statement issued by the American Heart Association (AHA) and American Stroke Association (ASA):
- No previous clear history of stroke and no clinical symptoms or mild clinical symptoms that fail to attract clinical attention;
- Cranial MRI showing at least one of the following within 5 years: lacunar infarct of vascular origin, white matter hyperintensity of vascular origin, cerebral microbleeds;
- Consciousness and ability to complete cognitive assessment
- Ability to stand and walk independently and complete gait assessment without assistance from others.
- Ability to sign the informed consent.
Who cannot join
- Intracranial lesions that have been clearly diagnosed as demyelination disease, white matter dystrophy, intracranial space-occupying lesions, or autoimmune encephalitis.
- Gait disorder that has been diagnosed as Parkinson's disease, normal cranial hydrocephalus, an otogenic disease, subacute combined degeneration, peripheral neuropathy, osteoarthritis, or lumbar disease.
- Cognitive disorders that have been diagnosed, such as Alzheimer's disease, frontotemporal dementia, Lewy body dementia, etc.
- Severe neurological diseases such as previous cerebral trauma, epilepsy, and myelopathy, etc.
- Severe cardiovascular complications and intolerance to the assessment
- Severe visual or hearing impairment, aphasia, cognitive disorder, gait disorder, etc., that results in the inability to cooperate for cognitive and gait assessment
- Refusal to participate in the study
- Other anomalies that could not be included in the exclusion criteria, but are considered inappropriate to be included in this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: the Effectiveness and Cost Effectiveness in Screening Gait Disorder of Silent Cerebrovascular Disease Assisted by Artificial Intelligent System and Clinical Doctors - A Randomized Parallel-controlled Study
This is a multi-center, randomized, double-blind, parallel-controlled, prospective study to compare the effectiveness and cost-effectiveness of intelligent and doctor groups for gait disorder screening.
Clinical data, including demographic characteristics, socioeconomic level, medical history, assessment of neurological function, laboratory tests, imaging tests, health service utilization, and costs will be collected from the subjects. All subjects will be divided into an intelligent group and a doctor group according to a 1:1 ratio. The intelligent group will undergo intelligent system evaluation, and the doctor group will undergo the clinician's conventional treatment process. At the same time, all the subjects will undergo gold-standard panel gait and cognitive rating scale assessments.
Read the detailed description
All subjects in the intelligent group will undergo tests to evaluate their nervous system function, including the timed up-and-go test, mini-cognitive assessment, and sentence repetition. Subjects will be recorded using a camera and microphone. The intelligent system uses the built-in intelligent algorithm to analyze the gait video, sound, and picture to provide information on gait features (stand-up time, turnaround time, stride length, step velocity, stride length, step width, etc.), language features (pronunciation, intonation, word order, language accuracy, language fluency, etc.), and clock features (contour, numbers, pointers, etc.).
All subjects in the doctor group will consult with a doctor in the non-intelligent group according to the routine treatment procedure. Doctors in the non-intelligent group are required to be internal medicine clinicians with intermediate title or below, and they should have registered their qualifications, relevant knowledge and training experience, educational background, and other information in the early stage of the study. The doctors in the non-intelligent group will make clinical diagnoses for the subjects based on routine medical operations such as a history of the present illness, previous history, and physical examination, and the data in medical records in the outpatient department will help determine whether the subjects have gait disorders.
All subjects' walking videos will be assessed by the gold-standard panel, which will consist of 2 experts of movement disorders. If there is any difference, a third expert will be included in the evaluation. According to the clinical experience, the expert doctors will evaluate the subjects' gait, and the results will be divided into normal gait and abnormal gait.
- Conditions
- Silent Stroke
- Being tested
- intelligent assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intelligent assessmentDiagnostic test
intelligent neurological function assessment
| Study group | Role | What they receive |
|---|---|---|
| intelligent | Other | receive the neurological function assessment by artificial intelligence Receives: Diagnostic Test: intelligent assessment |
| manual | No intervention | receive the neurological function assessment by doctor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Compared with the gold standard panel of neurology, the sensitivity of the intelligent system and clinicians to screen for gait disorders
Measured: baseline
Secondary outcomes (5)
Specificity
the specificity of the intelligent system and clinicians to screen for gait disorders
Measured: baseline
Coincidence
the coincidence of the intelligent system and clinicians to screen for gait disorders
Measured: baseline
Yoden index
the Yoden index of the intelligent system and clinicians to screen for gait disorders
Measured: baseline
Positive predictive value and negative predictive value
the positive predictive value and negative predictive value of the intelligent system and clinicians at different levels to screen for gait disorders
Measured: baseline
Cost and cost-effectiveness
Health care utilization and costs will be collected to calculate direct and indirect costs of the intelligent system and clinicians to screen for gait disorders, and the incremental cost-effectiveness ratio (ICER) will be computed.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Jul 2020 (estimated)
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Silent StrokeStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, The Affiliated Hospital Of Guizhou Medical University
- Responsible party
- Sponsor
- Investigators
- Jing Ding, MD, Study director, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457908
- Sponsor's protocol ID
- 2018YFC1312900-05
- Acronym
- ACCURATE-1
- Status last verified
- Oct 2019
- First submitted
- 1 Jul 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Poels MM, Steyerberg EW, Wieberdink RG, Hofman A, Koudstaal PJ, Ikram MA, Breteler MM. Assessment of cerebral small vessel disease predicts individual stroke risk. J Neurol Neurosurg Psychiatry. 2012 Dec;83(12):1174-9. doi: 10.1136/jnnp-2012-302381. Epub 2012 Aug 23.
PubMed 22917672Kim BJ, Lee SH. Prognostic Impact of Cerebral Small Vessel Disease on Stroke Outcome. J Stroke. 2015 May;17(2):101-10. doi: 10.5853/jos.2015.17.2.101. Epub 2015 May 29.
PubMed 26060797Sachdev PS, Wen W, Christensen H, Jorm AF. White matter hyperintensities are related to physical disability and poor motor function. J Neurol Neurosurg Psychiatry. 2005 Mar;76(3):362-7. doi: 10.1136/jnnp.2004.042945.
PubMed 15716527Murray ME, Senjem ML, Petersen RC, Hollman JH, Preboske GM, Weigand SD, Knopman DS, Ferman TJ, Dickson DW, Jack CR Jr. Functional impact of white matter hyperintensities in cognitively normal elderly subjects. Arch Neurol. 2010 Nov;67(11):1379-85. doi: 10.1001/archneurol.2010.280.
PubMed 21060015Wakefield DB, Moscufo N, Guttmann CR, Kuchel GA, Kaplan RF, Pearlson G, Wolfson L. White matter hyperintensities predict functional decline in voiding, mobility, and cognition in older adults. J Am Geriatr Soc. 2010 Feb;58(2):275-81. doi: 10.1111/j.1532-5415.2009.02699.x. Epub 2010 Jan 26.
PubMed 20374403Debette S, Markus HS. The clinical importance of white matter hyperintensities on brain magnetic resonance imaging: systematic review and meta-analysis. BMJ. 2010 Jul 26;341:c3666. doi: 10.1136/bmj.c3666.
PubMed 20660506Brickman AM, Provenzano FA, Muraskin J, Manly JJ, Blum S, Apa Z, Stern Y, Brown TR, Luchsinger JA, Mayeux R. Regional white matter hyperintensity volume, not hippocampal atrophy, predicts incident Alzheimer disease in the community. Arch Neurol. 2012 Dec;69(12):1621-7. doi: 10.1001/archneurol.2012.1527.
PubMed 22945686Maillard P, Carmichael O, Fletcher E, Reed B, Mungas D, DeCarli C. Coevolution of white matter hyperintensities and cognition in the elderly. Neurology. 2012 Jul 31;79(5):442-8. doi: 10.1212/WNL.0b013e3182617136. Epub 2012 Jul 18.
PubMed 22815562Smith EE, Saposnik G, Biessels GJ, Doubal FN, Fornage M, Gorelick PB, Greenberg SM, Higashida RT, Kasner SE, Seshadri S; American Heart Association Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Functional Genomics and Translational Biology; and Council on Hypertension. Prevention of Stroke in Patients With Silent Cerebrovascular Disease: A Scientific Statement for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2017 Feb;48(2):e44-e71. doi: 10.1161/STR.0000000000000116. Epub 2016 Dec 15.
PubMed 27980126Leary MC, Saver JL. Annual incidence of first silent stroke in the United States: a preliminary estimate. Cerebrovasc Dis. 2003;16(3):280-5. doi: 10.1159/000071128.
PubMed 12865617Kim YJ, Kwon HK, Lee JM, Cho H, Kim HJ, Park HK, Jung NY, San Lee J, Lee J, Jang YK, Kim ST, Lee KH, Choe YS, Kim YJ, Na DL, Seo SW. Gray and white matter changes linking cerebral small vessel disease to gait disturbances. Neurology. 2016 Mar 29;86(13):1199-207. doi: 10.1212/WNL.0000000000002516. Epub 2016 Mar 2.
PubMed 26935893de Laat KF, van Norden AG, Gons RA, van Oudheusden LJ, van Uden IW, Bloem BR, Zwiers MP, de Leeuw FE. Gait in elderly with cerebral small vessel disease. Stroke. 2010 Aug;41(8):1652-8. doi: 10.1161/STROKEAHA.110.583229. Epub 2010 Jun 24.
PubMed 20576951Montero-Odasso MM, Sarquis-Adamson Y, Speechley M, Borrie MJ, Hachinski VC, Wells J, Riccio PM, Schapira M, Sejdic E, Camicioli RM, Bartha R, McIlroy WE, Muir-Hunter S. Association of Dual-Task Gait With Incident Dementia in Mild Cognitive Impairment: Results From the Gait and Brain Study. JAMA Neurol. 2017 Jul 1;74(7):857-865. doi: 10.1001/jamaneurol.2017.0643.
PubMed 28505243Wardlaw JM, Smith EE, Biessels GJ, Cordonnier C, Fazekas F, Frayne R, Lindley RI, O'Brien JT, Barkhof F, Benavente OR, Black SE, Brayne C, Breteler M, Chabriat H, Decarli C, de Leeuw FE, Doubal F, Duering M, Fox NC, Greenberg S, Hachinski V, Kilimann I, Mok V, Oostenbrugge Rv, Pantoni L, Speck O, Stephan BC, Teipel S, Viswanathan A, Werring D, Chen C, Smith C, van Buchem M, Norrving B, Gorelick PB, Dichgans M; STandards for ReportIng Vascular changes on nEuroimaging (STRIVE v1). Neuroimaging standards for research into small vessel disease and its contribution to ageing and neurodegeneration. Lancet Neurol. 2013 Aug;12(8):822-38. doi: 10.1016/S1474-4422(13)70124-8.
PubMed 23867200Vermeer SE, Longstreth WT Jr, Koudstaal PJ. Silent brain infarcts: a systematic review. Lancet Neurol. 2007 Jul;6(7):611-9. doi: 10.1016/S1474-4422(07)70170-9.
PubMed 17582361
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effectiveness and Cost Effectiveness in Screening Gait Disorder of Silent Cerebrovascular Disease Assisted by Artificial Intelligent System and Clinical Doctors - A Randomized Parallel-controlled Study
- ClinicalTrials.gov ID
- NCT04457908
- Acronym / sponsor ID
- ACCURATE-1 / 2018YFC1312900-05
- Conditions
- Silent Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Fudan University, The Affiliated Hospital Of Guizhou Medical University
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 7 Jul 2020 (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.
This is a multi-center, randomized, double-blind, parallel-controlled, prospective study to compare the effectiveness and cost-effectiveness of intelligent and doctor groups for gait disorder screening.
Clinical data, including demographic characteristics, socioeconomic level, medical history, assessment of neurological function, laboratory tests, imaging tests, health service utilization, and costs will be collected from the subjects. All subjects will be divided into an intelligent group and a doctor group according to a 1:1 ratio. The intelligent group will undergo intelligent system evaluation, and the doctor group will undergo the clinician's conventional treatment process. At the same time, all the subjects will undergo gold-standard panel gait and cognitive rating scale assessments.
Detailed description
All subjects in the intelligent group will undergo tests to evaluate their nervous system function, including the timed up-and-go test, mini-cognitive assessment, and sentence repetition. Subjects will be recorded using a camera and microphone. The intelligent system uses the built-in intelligent algorithm to analyze the gait video, sound, and picture to provide information on gait features (stand-up time, turnaround time, stride length, step velocity, stride length, step width, etc.), language features (pronunciation, intonation, word order, language accuracy, language fluency, etc.), and clock features (contour, numbers, pointers, etc.).
All subjects in the doctor group will consult with a doctor in the non-intelligent group according to the routine treatment procedure. Doctors in the non-intelligent group are required to be internal medicine clinicians with intermediate title or below, and they should have registered their qualifications, relevant knowledge and training experience, educational background, and other information in the early stage of the study. The doctors in the non-intelligent group will make clinical diagnoses for the subjects based on routine medical operations such as a history of the present illness, previous history, and physical examination, and the data in medical records in the outpatient department will help determine whether the subjects have gait disorders.
All subjects' walking videos will be assessed by the gold-standard panel, which will consist of 2 experts of movement disorders. If there is any difference, a third expert will be included in the evaluation. According to the clinical experience, the expert doctors will evaluate the subjects' gait, and the results will be divided into normal gait and abnormal gait.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intelligent | Other | Diagnostic Test: intelligent assessmentreceive the neurological function assessment by artificial intelligence |
| manual | No intervention | –receive the neurological function assessment by doctor |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged between 60 and 85 years.
- Diagnosed with silent cerebrovascular disease/silent stroke, which is consistent with the 2016 statement issued by the American Heart Association (AHA) and American Stroke Association (ASA):
- Consciousness and ability to complete cognitive assessment
- Ability to stand and walk independently and complete gait assessment without assistance from others.
- Ability to sign the informed consent.
Key exclusion criteria (8 listed)
- Intracranial lesions that have been clearly diagnosed as demyelination disease, white matter dystrophy, intracranial space-occupying lesions, or autoimmune encephalitis.
- Gait disorder that has been diagnosed as Parkinson's disease, normal cranial hydrocephalus, an otogenic disease, subacute combined degeneration, peripheral neuropathy, osteoarthritis, or lumbar disease.
- Cognitive disorders that have been diagnosed, such as Alzheimer's disease, frontotemporal dementia, Lewy body dementia, etc.
- Severe neurological diseases such as previous cerebral trauma, epilepsy, and myelopathy, etc.
- Severe cardiovascular complications and intolerance to the assessment
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 |
|---|---|---|
| intelligent assessmentintelligent neurological function assessment | Diagnostic test | intelligent |
Primary outcome
Sensitivity
Time frame: baseline
Compared with the gold standard panel of neurology, the sensitivity of the intelligent system and clinicians to screen for gait disorders
5 secondary outcomes
Specificity
Time frame: baseline
Coincidence
Time frame: baseline
Yoden index
Time frame: baseline
Positive predictive value and negative predictive value
Time frame: baseline
Cost and cost-effectiveness
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Background: PubMed 22917672Poels MM, Steyerberg EW, Wieberdink RG, Hofman A, Koudstaal PJ, Ikram MA, Breteler MM. Assessment of cerebral small vessel disease predicts individual stroke risk. J Neurol Neurosurg Psychiatry. 2012 Dec;83(12):1174-9. doi: 10.1136/jnnp-2012-302381. Epub 2012 Aug 23.
- Background: PubMed 26060797Kim BJ, Lee SH. Prognostic Impact of Cerebral Small Vessel Disease on Stroke Outcome. J Stroke. 2015 May;17(2):101-10. doi: 10.5853/jos.2015.17.2.101. Epub 2015 May 29.
- Background: PubMed 15716527Sachdev PS, Wen W, Christensen H, Jorm AF. White matter hyperintensities are related to physical disability and poor motor function. J Neurol Neurosurg Psychiatry. 2005 Mar;76(3):362-7. doi: 10.1136/jnnp.2004.042945.
- Background: PubMed 21060015Murray ME, Senjem ML, Petersen RC, Hollman JH, Preboske GM, Weigand SD, Knopman DS, Ferman TJ, Dickson DW, Jack CR Jr. Functional impact of white matter hyperintensities in cognitively normal elderly subjects. Arch Neurol. 2010 Nov;67(11):1379-85. doi: 10.1001/archneurol.2010.280.
- Background: PubMed 20374403Wakefield DB, Moscufo N, Guttmann CR, Kuchel GA, Kaplan RF, Pearlson G, Wolfson L. White matter hyperintensities predict functional decline in voiding, mobility, and cognition in older adults. J Am Geriatr Soc. 2010 Feb;58(2):275-81. doi: 10.1111/j.1532-5415.2009.02699.x. Epub 2010 Jan 26.
- Background: PubMed 20660506Debette S, Markus HS. The clinical importance of white matter hyperintensities on brain magnetic resonance imaging: systematic review and meta-analysis. BMJ. 2010 Jul 26;341:c3666. doi: 10.1136/bmj.c3666.
- Background: PubMed 22945686Brickman AM, Provenzano FA, Muraskin J, Manly JJ, Blum S, Apa Z, Stern Y, Brown TR, Luchsinger JA, Mayeux R. Regional white matter hyperintensity volume, not hippocampal atrophy, predicts incident Alzheimer disease in the community. Arch Neurol. 2012 Dec;69(12):1621-7. doi: 10.1001/archneurol.2012.1527.
- Background: PubMed 22815562Maillard P, Carmichael O, Fletcher E, Reed B, Mungas D, DeCarli C. Coevolution of white matter hyperintensities and cognition in the elderly. Neurology. 2012 Jul 31;79(5):442-8. doi: 10.1212/WNL.0b013e3182617136. Epub 2012 Jul 18.
- Background: PubMed 27980126Smith EE, Saposnik G, Biessels GJ, Doubal FN, Fornage M, Gorelick PB, Greenberg SM, Higashida RT, Kasner SE, Seshadri S; American Heart Association Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Functional Genomics and Translational Biology; and Council on Hypertension. Prevention of Stroke in Patients With Silent Cerebrovascular Disease: A Scientific Statement for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2017 Feb;48(2):e44-e71. doi: 10.1161/STR.0000000000000116. Epub 2016 Dec 15.
- Background: PubMed 12865617Leary MC, Saver JL. Annual incidence of first silent stroke in the United States: a preliminary estimate. Cerebrovasc Dis. 2003;16(3):280-5. doi: 10.1159/000071128.
- Background: PubMed 26935893Kim YJ, Kwon HK, Lee JM, Cho H, Kim HJ, Park HK, Jung NY, San Lee J, Lee J, Jang YK, Kim ST, Lee KH, Choe YS, Kim YJ, Na DL, Seo SW. Gray and white matter changes linking cerebral small vessel disease to gait disturbances. Neurology. 2016 Mar 29;86(13):1199-207. doi: 10.1212/WNL.0000000000002516. Epub 2016 Mar 2.
- Background: PubMed 20576951de Laat KF, van Norden AG, Gons RA, van Oudheusden LJ, van Uden IW, Bloem BR, Zwiers MP, de Leeuw FE. Gait in elderly with cerebral small vessel disease. Stroke. 2010 Aug;41(8):1652-8. doi: 10.1161/STROKEAHA.110.583229. Epub 2010 Jun 24.
- Individual participant dataSharing planned: No
Related trials for Silent Stroke
Active, not recruitingObservational study
Stroke Prevention in Young Adults With Sickle Cell Anemia
Sickle Cell Disease, Sickle Cell Anemia
Enrolling by invitationObservational study
Federated Learning for Point-of-Care Cardiac Ultrasound
Ventricular Dysfunction, Left, Ventricular Function, Left
Active, not recruitingPhase 4
Efficacy of Clopidogrel on Incidence of Silent Brain Infarction
Silent Brain Infarction
Recruiting
A Standard Carbon Dioxide Flushing Protocol to Reduce Air Embolization During Thoracic Endovascular Aortic Repair
Type B Acute Aortic Syndrome, Thoracic and Thoracoabdominal Aneurysms With Crawford Extent I, II, III, or IV
Active, not recruiting
Multidisciplinary Lifestyle Interventions for Neurological Disorders During the Silent Phase
Neurological Disorder
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.
Jing Ding, MD study director
Shanghai Zhongshan Hospital
Questions about this trial
What is this clinical trial studying?
A study testing intelligent assessment in people with Silent Stroke, run by Shanghai Zhongshan Hospital.
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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beini Fei, MB (+86 13701699684, fbeini@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: baseline). 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 NCT04457908, which also lists 19 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 7 Jul 2020.