Healthy SubjectsPRECISENCT03178448
PolyvasculaR Evaluation for Cognitive Impairment and vaScular Events
An observational study of Healthy Subjects, run by Beijing Tiantan Hospital at 2 sites in China.
Trial summary
The objective of this study is to characterize the prevalence of clinical or subclinical polyvascular lesions and 4-year progression rate of plaque in intracranial and carotidal arteries in a Chinese community population using vascular imaging techniques; to investigate the both traditional and emerging genetic… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- How many people
- 3,067 participants
- Where
- 2 sitesChina
- Study dates
- 15 May 2017to 30 Jul 2023
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The target population of the study consists of community population aged 50-75 years in Lishui city in southeast of China.
Who may be able to join
- Community population in Lishui city;
- Age between 50 and 75 years.
Who cannot join
- Mental illness;
- Advanced cancers or any disease that decreases life expectation to ≤4 years;
- Allergy to iodine contrast, renal failure with creatinine clearance <60 mL/min, or blood urea nitrogen (BUN) or creatinine (CR) more than upper limit of the normal range that contraindicates CTA;
- Pacemaker, implantable automatic defibrillator, or any implanted device that contraindicates MRI.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100050
Lishui Hospital of Zhejiang University (the Central Hospital of Lishui)
Lishui, Zhejiang, 323000
About this study
Official title: PolyvasculaR Evaluation for Cognitive Impairment and vaScular Events (PRECISE)
The objective of this study is to characterize the prevalence of clinical or subclinical polyvascular lesions and 4-year progression rate of plaque in intracranial and carotidal arteries in a Chinese community population using vascular imaging techniques; to investigate the both traditional and emerging genetic, metabolomic, and environmental risk factors of presence and progression of intracranial and carotidal plaque; and to investigate the association between polyvascular lesions and future risk of cognitive impairment, cardio-/cerebrovascular events and death.
Read the detailed description
Atherosclerosis is the most common cardiovascular disease and accounts for the greatest number of cardiovascular and cerebrovascular events and death. Polyvascular lesions with coexistent lesions (especially atherosclerosis) in multiple arterial territories (at least 2 of coronary, cerebral, lower extremity arteries), could be associated with higher risk of future cardio-/cerebrovascular diseases. However, previous studies either roughly defined polyvascular diseases according to established clinically recognized arterial diseases in multiple arterial territories, or tested multiterritorial subclinical atherosclerosis without tests of intracranial and peripheral arteries. Furthermore, recent research also showed that cardiometabolic diseases and cardiovascular risk factors are associated with worse cognitive abilities. A thorough evaluation of multiterritorial lesions in whole body used advanced vascular imaging techniques is required to precisely assess the association of polyvascular lesions with future cardio-/cerebrovascular events and cognitive impairment.
Additionally, Asian population might have higher prevalence of intracranial atherosclerosis than the Caucasian, and intracranial atherosclerosis is the most common cause of ischemic stroke in Asia population. However, there are limited data about the prevalence and progression of intracranial atherosclerosis in Chinese population. More and more studies have shown that presence and progression of atherosclerotic plaque is not only related to the degree of stenosis, but also with plaque characteristics such as rich lipid core, plaque hemorrhage and inflammatory cell infiltration. High-resolution magnetic resonance (HR-MRI) can not only show the degree of arterial stenosis, the size of atherosclerotic plaque, but also can analyze the composition of the plaque to assess the stability of the plaque. HR-MRI techniques enable early detection of atherosclerosis, characterization of the atherosclerotic composition and burden. It is important to estimate the prevalence and progression rate of intracranial atherosclerotic plaque based on HR-MRI and to estimate its traditional and emerging determinants in Chinese population.
In this study, a total of 3000 subjects aged 50 to 75 years from 6 villages and 4 communities in Lishui city, Zhejiang province, China, will be enrolled. All the eligible subjects in the selected villages/community will be enrolled based on cluster sampling.
All the participants will be interviewed at baseline and followed up for 4 years. Data collection at baseline will be performed through face-to-face interviews by trained interviewers (neurologists from participating hospitals) with a standardized protocol. Baseline data include demographics, medical history, cardiovascular risk factors, dietary habits, physical activity, lifestyle, medication use, electrocardiogram, vascular imaging tests and Montreal Cognitive Assessment (MoCA). Blood and urine samples will also be collected at baseline to test genetic and metabolomic markers.
The sequences of brain MRI included T1,T2, FLAIR, DWI,ADC,MRA,SWI,T2*,T1-VISTA, SNAP,3D-T1,resting-state fMRI and DTI. Baseline vascular imaging tests include HR-MRI sequences in intracranial and carotidal arteries, computed tomographic angiography (CTA) in coronary, aorta, renal, hepatic, pancreatic and iliofemoral arteries, and fundus fluorescein photography (retinal photography) in retinal vessel. All MRI scans were performed on 3.0 T Philips scanners. CTA scans were performed on third-generation dual-source Siemens system (SOMATOM Force). HR-MRI sequences were performed both at baseline and after 4 years to identify intracranial and carotidal atherosclerotic stenosis and plaque and measure the intracranial and carotidal vessel wall, lumen area, and plaque when present. Additionally, heart function will be tested using color Doppler echocardiography, and ankle-brachial index will be tested using Doppler ultrasound. All the imaging techniques will be conducted in a fixed machine by fixed trained investigators based on a standardized protocol. These imaging techniques enable early detection of intracranial and extracranial vascular lesions, characterization of the atherosclerotic composition and burden, and monitoring of plaque progression in intracranial and carotidal arteries.
Routine follow-up will be performed each year to collect cardio-/cerebrovascular events and death after enrollment. A further face-to-face interview will be performed at 2 years and 4 years to collect brain MRI scanning and cognitive impairment. At 2-year and 4-year follow-up visits, standard clinical and neuropsychologic assessments will be performed, including MoCA, Mini-Mental State Exam scores, Geriatric Depression Scale, Digit Span, Rey Auditory Verbal Learning Test, Rey-Osterrieth Complex Figure Test, Trail Making A and B, Stroop Task, Verbal Fluency Test, Boston Naming Test, Clock Drawing Test, Symbol Digit Modalities Test, Neuropsychiatric Inventory and Clinical Dementia Rating. Fasting blood and morning urine samples will be collected at each follow-up visit following same protocol as that at baseline.
The protocol of this study was approved by the ethics committee of Beijing Tiantan Hospital and Lishui Hospital of Zhejiang University. All participants provided written informed consents before entering the study.
- Conditions
- Healthy Subjects
What is being measured
The primary outcome is the main question the study is designed to answer.
New composite vascular event 1
Any new event of nonfatal stroke (ischemic or hemorrhagic), nonfatal myocardial infarction (MI) or cardiovascular death (including fatal stroke, fatal MI, and other cardiovascular death).
Measured: 4 years
New composite vascular event 2
Any new event of nonfatal stroke, nonfatal MI, cardiovascular death, vascular interventions (bypass graft, angioplasty, stent and amputation for ischemia), or hospitalizations for vascular events (including unstable angina pectoris, transient ischemic attack (TIA) and other ischemic arterial event including worsening of peripheral vascular disease (PAD)).
Measured: 4 years
Secondary outcomes (12)
Prevalence of polyvascular lesions, including atherosclerotic stenosis and plaque;
Measured: at baseline
4-year progression rate of atherosclerotic plaque in intracranial and carotidal arteries.
Measured: 4 years
Fatal or nonfatal MI;
Measured: 4 years
Fatal or nonfatal stroke;
Measured: 4 years
Transient ischemic attack (TIA)
Measured: 4 years
All causes of death (cardiovascular or noncardiovascular death);
Measured: 4 years
Hospitalizations for vascular events;
Measured: 4 years
Vascular interventions;
Vascular interventions such as arterial bypass, balloon dilatation, stent implantation, carotid endarterectomy, mechanical thrombolysis and ischemic amputation.These events will be collected by self-reported by participants and confirmed by reviewing their medical records.
Measured: 4 years
Other vascular events (PAD, subclavian steal syndrome and systemic thromboembolic events);
Measured: 4 years
New diagnosed diabetes mellitus;
Measured: 4 years
New diagnosed chronic kidney disease;
Measured: 4 years
Cognitive impairment measured by the Montreal Cognitive Assessment (MoCA).
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start15 May 2017
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
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 Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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
- 3,067 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongjun Wang, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178448
- Sponsor's protocol ID
- 2016YFC0901001
- Acronym
- PRECISE
- Status last verified
- Mar 2020
- First submitted
- 31 May 2017
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data can be requested through the website of the data management system (http://paper.ncrcnd.org.cn/) or by sending email to the principal investigators.
Publications
Chen H, Zhang A, Chen W, Cai X, Zhou M, Li S, Jing J, Wei T, Wang Y, Pan Y, Wang Y. Association of Sleep Duration With Intracranial Atherosclerosis and Cerebral Small Vessel Disease: A Mediation by Metabolic Factors. CNS Neurosci Ther. 2026 Feb;32(2):e70797. doi: 10.1002/cns.70797.
PubMed 41700534Zhou M, Zhou Y, Jing J, Wang M, Jin A, Cai X, Meng X, Liu T, Wang Y, Wang Y, Pan Y. Insulin resistance and white matter microstructural abnormalities in nondiabetic adult: A population-based study. Int J Stroke. 2024 Dec;19(10):1162-1171. doi: 10.1177/17474930241266796. Epub 2024 Aug 3.
PubMed 38916129Zhou M, Mei L, Jing J, Yang Y, Cai X, Meng X, Jin A, Lin J, Li S, Li H, Wei T, Wang Y, Wang Y, Pan Y. Blood Pressure Partially Mediated the Association of Insulin Resistance and Cerebral Small Vessel Disease: A Community-Based Study. J Am Heart Assoc. 2024 Mar 5;13(5):e031723. doi: 10.1161/JAHA.123.031723. Epub 2024 Feb 23.
PubMed 38390815Zhou Y, Jing J, Zhang Z, Pan Y, Cai X, Zhu W, Li Z, Liu C, Liu H, Meng X, Cheng J, Wang Y, Li H, Wang S, Niu H, Wen W, Sachdev PS, Wei T, Liu T, Wang Y. Disrupted pattern of rich-club organization in structural brain network from prediabetes to diabetes: A population-based study. Hum Brain Mapp. 2024 Feb 1;45(2):e26598. doi: 10.1002/hbm.26598.
PubMed 38339955Cai X, Sun J, Jin A, Jing J, Wang S, Mei L, Meng X, Li S, Wei T, Wang Y, Pan Y. Association of insulin resistance with intra- and extra-cranial atherosclerotic burden in the nondiabetic community population. Neurobiol Dis. 2023 Oct 1;186:106268. doi: 10.1016/j.nbd.2023.106268. Epub 2023 Aug 23.
PubMed 37625526Tian Y, Cai X, Zhou Y, Jin A, Wang S, Yang Y, Mei L, Jing J, Li S, Meng X, Wei T, Liu T, Wang Y, Pan Y, Wang Y. Impaired glymphatic system as evidenced by low diffusivity along perivascular spaces is associated with cerebral small vessel disease: a population-based study. Stroke Vasc Neurol. 2023 Oct;8(5):413-423. doi: 10.1136/svn-2022-002191. Epub 2023 Apr 12.
PubMed 37045543Pan Y, Cai X, Jing J, Wang S, Meng X, Mei L, Yang Y, Jin A, DongXiao Y, Li S, Li H, Wei T, Wang Y, Wang Y. Differential associations of lipoprotein(a) level with cerebral large artery and small vessel diseases. Stroke Vasc Neurol. 2022 Jul 18;7(6):534-40. doi: 10.1136/svn-2022-001625. Online ahead of print.
PubMed 35851316Pan Y, Jing J, Cai X, Wang Y, Wang S, Meng X, Zeng C, Shi J, Ji J, Lin J, Lyu L, Zhang Z, Mei L, Li S, Li S, Zhu W, Li H, Wei T, Wang Y. PolyvasculaR Evaluation for Cognitive Impairment and vaScular Events (PRECISE)-a population-based prospective cohort study: rationale, design and baseline participant characteristics. Stroke Vasc Neurol. 2021 Mar;6(1):145-151. doi: 10.1136/svn-2020-000411. Epub 2020 Aug 30.
PubMed 32863279
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PolyvasculaR Evaluation for Cognitive Impairment and vaScular Events (PRECISE)
- ClinicalTrials.gov ID
- NCT03178448
- Acronym / sponsor ID
- PRECISE / 2016YFC0901001
- Conditions
- Healthy Subjects
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,067 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 7 Jun 2017 (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 objective of this study is to characterize the prevalence of clinical or subclinical polyvascular lesions and 4-year progression rate of plaque in intracranial and carotidal arteries in a Chinese community population using vascular imaging techniques; to investigate the both traditional and emerging genetic, metabolomic, and environmental risk factors of presence and progression of intracranial and carotidal plaque; and to investigate the association between polyvascular lesions and future risk of cognitive impairment, cardio-/cerebrovascular events and death.
Detailed description
Atherosclerosis is the most common cardiovascular disease and accounts for the greatest number of cardiovascular and cerebrovascular events and death. Polyvascular lesions with coexistent lesions (especially atherosclerosis) in multiple arterial territories (at least 2 of coronary, cerebral, lower extremity arteries), could be associated with higher risk of future cardio-/cerebrovascular diseases. However, previous studies either roughly defined polyvascular diseases according to established clinically recognized arterial diseases in multiple arterial territories, or tested multiterritorial subclinical atherosclerosis without tests of intracranial and peripheral arteries. Furthermore, recent research also showed that cardiometabolic diseases and cardiovascular risk factors are associated with worse cognitive abilities. A thorough evaluation of multiterritorial lesions in whole body used advanced vascular imaging techniques is required to precisely assess the association of polyvascular lesions with future cardio-/cerebrovascular events and cognitive impairment.
Additionally, Asian population might have higher prevalence of intracranial atherosclerosis than the Caucasian, and intracranial atherosclerosis is the most common cause of ischemic stroke in Asia population. However, there are limited data about the prevalence and progression of intracranial atherosclerosis in Chinese population. More and more studies have shown that presence and progression of atherosclerotic plaque is not only related to the degree of stenosis, but also with plaque characteristics such as rich lipid core, plaque hemorrhage and inflammatory cell infiltration. High-resolution magnetic resonance (HR-MRI) can not only show the degree of arterial stenosis, the size of atherosclerotic plaque, but also can analyze the composition of the plaque to assess the stability of the plaque. HR-MRI techniques enable early detection of atherosclerosis, characterization of the atherosclerotic composition and burden. It is important to estimate the prevalence and progression rate of intracranial atherosclerotic plaque based on HR-MRI and to estimate its traditional and emerging determinants in Chinese population.
In this study, a total of 3000 subjects aged 50 to 75 years from 6 villages and 4 communities in Lishui city, Zhejiang province, China, will be enrolled. All the eligible subjects in the selected villages/community will be enrolled based on cluster sampling.
All the participants will be interviewed at baseline and followed up for 4 years. Data collection at baseline will be performed through face-to-face interviews by trained interviewers (neurologists from participating hospitals) with a standardized protocol. Baseline data include demographics, medical history, cardiovascular risk factors, dietary habits, physical activity, lifestyle, medication use, electrocardiogram, vascular imaging tests and Montreal Cognitive Assessment (MoCA). Blood and urine samples will also be collected at baseline to test genetic and metabolomic markers.
The sequences of brain MRI included T1,T2, FLAIR, DWI,ADC,MRA,SWI,T2*,T1-VISTA, SNAP,3D-T1,resting-state fMRI and DTI. Baseline vascular imaging tests include HR-MRI sequences in intracranial and carotidal arteries, computed tomographic angiography (CTA) in coronary, aorta, renal, hepatic, pancreatic and iliofemoral arteries, and fundus fluorescein photography (retinal photography) in retinal vessel. All MRI scans were performed on 3.0 T Philips scanners. CTA scans were performed on third-generation dual-source Siemens system (SOMATOM Force). HR-MRI sequences were performed both at baseline and after 4 years to identify intracranial and carotidal atherosclerotic stenosis and plaque and measure the intracranial and carotidal vessel wall, lumen area, and plaque when present. Additionally, heart function will be tested using color Doppler echocardiography, and ankle-brachial index will be tested using Doppler ultrasound. All the imaging techniques will be conducted in a fixed machine by fixed trained investigators based on a standardized protocol. These imaging techniques enable early detection of intracranial and extracranial vascular lesions, characterization of the atherosclerotic composition and burden, and monitoring of plaque progression in intracranial and carotidal arteries.
Routine follow-up will be performed each year to collect cardio-/cerebrovascular events and death after enrollment. A further face-to-face interview will be performed at 2 years and 4 years to collect brain MRI scanning and cognitive impairment. At 2-year and 4-year follow-up visits, standard clinical and neuropsychologic assessments will be performed, including MoCA, Mini-Mental State Exam scores, Geriatric Depression Scale, Digit Span, Rey Auditory Verbal Learning Test, Rey-Osterrieth Complex Figure Test, Trail Making A and B, Stroop Task, Verbal Fluency Test, Boston Naming Test, Clock Drawing Test, Symbol Digit Modalities Test, Neuropsychiatric Inventory and Clinical Dementia Rating. Fasting blood and morning urine samples will be collected at each follow-up visit following same protocol as that at baseline.
The protocol of this study was approved by the ethics committee of Beijing Tiantan Hospital and Lishui Hospital of Zhejiang University. All participants provided written informed consents before entering the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The target population of the study consists of community population aged 50-75 years in Lishui city in southeast of China.
Key inclusion criteria (2 listed)
- Community population in Lishui city;
- Age between 50 and 75 years.
Key exclusion criteria (4 listed)
- Mental illness;
- Advanced cancers or any disease that decreases life expectation to ≤4 years;
- Allergy to iodine contrast, renal failure with creatinine clearance <60 mL/min, or blood urea nitrogen (BUN) or creatinine (CR) more than upper limit of the normal range that contraindicates CTA;
- Pacemaker, implantable automatic defibrillator, or any implanted device that contraindicates MRI.
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
New composite vascular event 1
Time frame: 4 years
Any new event of nonfatal stroke (ischemic or hemorrhagic), nonfatal myocardial infarction (MI) or cardiovascular death (including fatal stroke, fatal MI, and other cardiovascular death).
New composite vascular event 2
Time frame: 4 years
Any new event of nonfatal stroke, nonfatal MI, cardiovascular death, vascular interventions (bypass graft, angioplasty, stent and amputation for ischemia), or hospitalizations for vascular events (including unstable angina pectoris, transient ischemic attack (TIA) and other ischemic arterial event including worsening of peripheral vascular disease (PAD)).
12 secondary outcomes
Prevalence of polyvascular lesions, including atherosclerotic stenosis and plaque;
Time frame: at baseline
4-year progression rate of atherosclerotic plaque in intracranial and carotidal arteries.
Time frame: 4 years
Fatal or nonfatal MI;
Time frame: 4 years
Fatal or nonfatal stroke;
Time frame: 4 years
Transient ischemic attack (TIA)
Time frame: 4 years
All causes of death (cardiovascular or noncardiovascular death);
Time frame: 4 years
Hospitalizations for vascular events;
Time frame: 4 years
Vascular interventions;
Time frame: 4 years
Other vascular events (PAD, subclavian steal syndrome and systemic thromboembolic events);
Time frame: 4 years
New diagnosed diabetes mellitus;
Time frame: 4 years
New diagnosed chronic kidney disease;
Time frame: 4 years
Cognitive impairment measured by the Montreal Cognitive Assessment (MoCA).
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Derived from this study: PubMed 41700534Chen H, Zhang A, Chen W, Cai X, Zhou M, Li S, Jing J, Wei T, Wang Y, Pan Y, Wang Y. Association of Sleep Duration With Intracranial Atherosclerosis and Cerebral Small Vessel Disease: A Mediation by Metabolic Factors. CNS Neurosci Ther. 2026 Feb;32(2):e70797. doi: 10.1002/cns.70797.
- Derived from this study: PubMed 38916129Zhou M, Zhou Y, Jing J, Wang M, Jin A, Cai X, Meng X, Liu T, Wang Y, Wang Y, Pan Y. Insulin resistance and white matter microstructural abnormalities in nondiabetic adult: A population-based study. Int J Stroke. 2024 Dec;19(10):1162-1171. doi: 10.1177/17474930241266796. Epub 2024 Aug 3.
- Derived from this study: PubMed 38390815Zhou M, Mei L, Jing J, Yang Y, Cai X, Meng X, Jin A, Lin J, Li S, Li H, Wei T, Wang Y, Wang Y, Pan Y. Blood Pressure Partially Mediated the Association of Insulin Resistance and Cerebral Small Vessel Disease: A Community-Based Study. J Am Heart Assoc. 2024 Mar 5;13(5):e031723. doi: 10.1161/JAHA.123.031723. Epub 2024 Feb 23.
- Derived from this study: PubMed 38339955Zhou Y, Jing J, Zhang Z, Pan Y, Cai X, Zhu W, Li Z, Liu C, Liu H, Meng X, Cheng J, Wang Y, Li H, Wang S, Niu H, Wen W, Sachdev PS, Wei T, Liu T, Wang Y. Disrupted pattern of rich-club organization in structural brain network from prediabetes to diabetes: A population-based study. Hum Brain Mapp. 2024 Feb 1;45(2):e26598. doi: 10.1002/hbm.26598.
- Derived from this study: PubMed 37625526Cai X, Sun J, Jin A, Jing J, Wang S, Mei L, Meng X, Li S, Wei T, Wang Y, Pan Y. Association of insulin resistance with intra- and extra-cranial atherosclerotic burden in the nondiabetic community population. Neurobiol Dis. 2023 Oct 1;186:106268. doi: 10.1016/j.nbd.2023.106268. Epub 2023 Aug 23.
- Derived from this study: PubMed 37045543Tian Y, Cai X, Zhou Y, Jin A, Wang S, Yang Y, Mei L, Jing J, Li S, Meng X, Wei T, Liu T, Wang Y, Pan Y, Wang Y. Impaired glymphatic system as evidenced by low diffusivity along perivascular spaces is associated with cerebral small vessel disease: a population-based study. Stroke Vasc Neurol. 2023 Oct;8(5):413-423. doi: 10.1136/svn-2022-002191. Epub 2023 Apr 12.
- Derived from this study: PubMed 35851316Pan Y, Cai X, Jing J, Wang S, Meng X, Mei L, Yang Y, Jin A, DongXiao Y, Li S, Li H, Wei T, Wang Y, Wang Y. Differential associations of lipoprotein(a) level with cerebral large artery and small vessel diseases. Stroke Vasc Neurol. 2022 Jul 18;7(6):534-40. doi: 10.1136/svn-2022-001625. Online ahead of print.
- Derived from this study: PubMed 32863279Pan Y, Jing J, Cai X, Wang Y, Wang S, Meng X, Zeng C, Shi J, Ji J, Lin J, Lyu L, Zhang Z, Mei L, Li S, Li S, Zhu W, Li H, Wei T, Wang Y. PolyvasculaR Evaluation for Cognitive Impairment and vaScular Events (PRECISE)-a population-based prospective cohort study: rationale, design and baseline participant characteristics. Stroke Vasc Neurol. 2021 Mar;6(1):145-151. doi: 10.1136/svn-2020-000411. Epub 2020 Aug 30.
- Individual participant dataSharing planned: Yes. The data can be requested through the website of the data management system (http://paper.ncrcnd.org.cn/) or by sending email to the principal investigators.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Healthy Subjects, run by Beijing Tiantan 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 2 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: status not confirmed, as of the sponsor's last update on 19 Mar 2020. 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?
Results are not available in the source record.
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?
New composite vascular event 1 (time frame: 4 years). The study lists 2 primary outcomes in all. 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 NCT03178448, 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 19 Mar 2020.