Silent StrokeACCURATE-2NCT04456348
Association Between Gait Assessed by Intelligent System and Cognitive Function in Silent Cerebrovascular Disease
An observational study of Silent Stroke, run by Shanghai Zhongshan Hospital.
Trial summary
This study is a multi-center prospective cohort study. We will continuously recruit subjects with silent cerebrovascular disease aged 60 to 85 years from Shanghai and Guizhou. Data including demographic characteristics, medical history, other concomitant diseases, neurological function assessments, laboratory… Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Silent Stroke
- How many people
- 1,600 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 31 Dec 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: with silent cerebrovascular disease patient aged 60 to 85 in Shanghai and Guizhou
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: Association Between Gait Features Assessed by Artificial Intelligent System and Cognitive Function Decline in the Patients of Silent Cerebrovascular Disease: A Multicenter Prospective Cohort Study
This study is a multi-center prospective cohort study. We will continuously recruit subjects with silent cerebrovascular disease aged 60 to 85 years from Shanghai and Guizhou. Data including demographic characteristics, medical history, other concomitant diseases, neurological function assessments, laboratory examinations, imaging examinations, and other clinical data and health economics survey responses will be collected from all subjects.
At baseline, all subjects will undergo gait assessment using the intelligent system and cognitive function scale assessment by clinicians. According to the intelligent gait results, the subjects will be divided into normal and abnormal gait groups. All subjects will be observed naturally for 1 year, and all medical behaviors will be recorded. All subjects will be interviewed by telephone for the occurrence of vascular events and changes in medical behaviors at half a year after enrollment and followed up at 1 year after enrollment, including gait evaluation using the intelligent system and cognitive function scale evaluation by clinicians. During the follow-up period, patients can visit the hospital for follow-up at any time when their condition changes.
Read the detailed description
The neurological function of all subjects was assessed based on the following tests under the guidance of a physician. The timed up-and-go test was used to evaluate the subjects' gait function, requiring them to stand up from their seat and walk straight forward for 3 meters, turn around, walk straight back to the chair, and then sit down again. Using simple cognitive evaluation (Mini-Cognitive Assessment) screening of the subjects' memory and executive function, the participants will first be asked to remember three unrelated words and immediately repeat the three words; they will then be asked to draw a clock marked with the numbers and pointers, and eventually recall the three words. The verbal function of the subjects will be assessed using the verbal retelling items in the MMSE and Montreal Cognitive Assessment, asking the subjects to clearly repeat "44 stone lions," "I only know Zhang Liang came to help today," and "the cat always hid under the sofa when the dog was in the room." Through the camera image data record, the intelligent system uses the built-in intelligent algorithm for intelligent video gait recognition and neural networks based on depth interpretation automation and automatic access to the subjects' gait characteristics (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.
- Conditions
- Silent Stroke
- Being tested
- there is no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
there is no interventionOther
There is no intervention
| Study group | Role | What they receive |
|---|---|---|
| positive | Subjects have gait disorder according to intelligent gait assessment at baseline. Receives: Other: there is no intervention | |
| negative | Subjects don't have gait disorder according to intelligent gait assessment at baseline. Receives: Other: there is no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive assessment scale score(MMSE)
It will be assessed by the Mini-Mental state examination (MMSE), which is scored 0-30.
Measured: 1 year
Secondary outcomes (5)
Change in cognitive assessment scale score(MoCA)
It will be assessed by the Montreal cognitive assessment (MoCA), which is scored 0-30.
Measured: 1 year
the prevalence of gait disorders
the prevalence of gait disorders, according to the intelligent assessment
Measured: baseline
the prevalence of cognitive disorder
the prevalence of cognitive disorder, according to the MMSE
Measured: baseline
the incidence of vascular events
the incidence of vascular events, including Cardiovascular and cerebrovascular events
Measured: 1 year
the incidence of fall incidence
the incidence of fall incidence
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Jul 2020 (estimated)
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Silent 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
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital Of Guizhou Medical University, Fudan University
- Responsible party
- Sponsor
- Investigators
- Jing Ding, MD, Study director, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456348
- Sponsor's protocol ID
- 2018YFC1312900-01
- Acronym
- ACCURATE-2
- Status last verified
- Nov 2019
- First submitted
- 30 Jun 2020
- Last updated
- 2 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 27980126Feigin VL, Forouzanfar MH, Krishnamurthi R, Mensah GA, Connor M, Bennett DA, Moran AE, Sacco RL, Anderson L, Truelsen T, O'Donnell M, Venketasubramanian N, Barker-Collo S, Lawes CM, Wang W, Shinohara Y, Witt E, Ezzati M, Naghavi M, Murray C; Global Burden of Diseases, Injuries, and Risk Factors Study 2010 (GBD 2010) and the GBD Stroke Experts Group. Global and regional burden of stroke during 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet. 2014 Jan 18;383(9913):245-54. doi: 10.1016/s0140-6736(13)61953-4.
PubMed 24449944Leary 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 12865617Vermeer SE, Hollander M, van Dijk EJ, Hofman A, Koudstaal PJ, Breteler MM; Rotterdam Scan Study. Silent brain infarcts and white matter lesions increase stroke risk in the general population: the Rotterdam Scan Study. Stroke. 2003 May;34(5):1126-9. doi: 10.1161/01.STR.0000068408.82115.D2. Epub 2003 Apr 10.
PubMed 12690219Kim 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 28505243
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Gait Features Assessed by Artificial Intelligent System and Cognitive Function Decline in the Patients of Silent Cerebrovascular Disease: A Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04456348
- Acronym / sponsor ID
- ACCURATE-2 / 2018YFC1312900-01
- Conditions
- Silent Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- The Affiliated Hospital Of Guizhou Medical University, Fudan University
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 2 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 study is a multi-center prospective cohort study. We will continuously recruit subjects with silent cerebrovascular disease aged 60 to 85 years from Shanghai and Guizhou. Data including demographic characteristics, medical history, other concomitant diseases, neurological function assessments, laboratory examinations, imaging examinations, and other clinical data and health economics survey responses will be collected from all subjects.
At baseline, all subjects will undergo gait assessment using the intelligent system and cognitive function scale assessment by clinicians. According to the intelligent gait results, the subjects will be divided into normal and abnormal gait groups. All subjects will be observed naturally for 1 year, and all medical behaviors will be recorded. All subjects will be interviewed by telephone for the occurrence of vascular events and changes in medical behaviors at half a year after enrollment and followed up at 1 year after enrollment, including gait evaluation using the intelligent system and cognitive function scale evaluation by clinicians. During the follow-up period, patients can visit the hospital for follow-up at any time when their condition changes.
Detailed description
The neurological function of all subjects was assessed based on the following tests under the guidance of a physician. The timed up-and-go test was used to evaluate the subjects' gait function, requiring them to stand up from their seat and walk straight forward for 3 meters, turn around, walk straight back to the chair, and then sit down again. Using simple cognitive evaluation (Mini-Cognitive Assessment) screening of the subjects' memory and executive function, the participants will first be asked to remember three unrelated words and immediately repeat the three words; they will then be asked to draw a clock marked with the numbers and pointers, and eventually recall the three words. The verbal function of the subjects will be assessed using the verbal retelling items in the MMSE and Montreal Cognitive Assessment, asking the subjects to clearly repeat "44 stone lions," "I only know Zhang Liang came to help today," and "the cat always hid under the sofa when the dog was in the room." Through the camera image data record, the intelligent system uses the built-in intelligent algorithm for intelligent video gait recognition and neural networks based on depth interpretation automation and automatic access to the subjects' gait characteristics (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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| positive | – | Other: there is no interventionSubjects have gait disorder according to intelligent gait assessment at baseline. |
| negative | – | Other: there is no interventionSubjects don't have gait disorder according to intelligent gait assessment at baseline. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- with silent cerebrovascular disease patient aged 60 to 85 in Shanghai and Guizhou
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 |
|---|---|---|
| there is no interventionThere is no intervention | Other | negative, positive |
Primary outcome
Change in cognitive assessment scale score(MMSE)
Time frame: 1 year
It will be assessed by the Mini-Mental state examination (MMSE), which is scored 0-30.
5 secondary outcomes
Change in cognitive assessment scale score(MoCA)
Time frame: 1 year
the prevalence of gait disorders
Time frame: baseline
the prevalence of cognitive disorder
Time frame: baseline
the incidence of vascular events
Time frame: 1 year
the incidence of fall incidence
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 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 24449944Feigin VL, Forouzanfar MH, Krishnamurthi R, Mensah GA, Connor M, Bennett DA, Moran AE, Sacco RL, Anderson L, Truelsen T, O'Donnell M, Venketasubramanian N, Barker-Collo S, Lawes CM, Wang W, Shinohara Y, Witt E, Ezzati M, Naghavi M, Murray C; Global Burden of Diseases, Injuries, and Risk Factors Study 2010 (GBD 2010) and the GBD Stroke Experts Group. Global and regional burden of stroke during 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet. 2014 Jan 18;383(9913):245-54. doi: 10.1016/s0140-6736(13)61953-4.
- 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 12690219Vermeer SE, Hollander M, van Dijk EJ, Hofman A, Koudstaal PJ, Breteler MM; Rotterdam Scan Study. Silent brain infarcts and white matter lesions increase stroke risk in the general population: the Rotterdam Scan Study. Stroke. 2003 May;34(5):1126-9. doi: 10.1161/01.STR.0000068408.82115.D2. Epub 2003 Apr 10.
- 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
RecruitingObservational study
Intraoperative Diagnosis of Neurocognitive Complications Via Electroencephalographic Analysis
Surgery, Postoperative Delirium
Enrolling by invitationObservational study
COR-INSIGHT: Optimizing Cardiovascular and Cardiopulmonary Outcomes with AI-Driven Multiplexed Indications Using COR ECG Wearable
Cardiopulmonary Failure, Myocardial Infarction (MI)
RecruitingObservational study
Incidence of Silent Atrial Fibrillation in Patients With Clinically Silent Brain Ischemic Lesions
Silent Stroke, Silent Cerebral Infarct
RecruitingObservational study
Prevalence of Attributable Etiology and Modifiable Stroke Risk Factors in Patients With Covert Brain Infarctions
Silent Stroke, Silent Cerebral Infarct
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?
An observational study of 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 2 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?
Change in cognitive assessment scale score(MMSE) (time frame: 1 year). 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 NCT04456348, which also lists 20 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 2 Jul 2020; AzTrials last refreshed its copy on 27 Oct 2026.