Cerebral Small Vessel DiseasesMODESTNCT06077305
A Registry Study of Microcirculation Disorder After Cerebral Small Vessel Disease and Ischemic Stroke
An observational study of Cerebral Small Vessel Diseases and Ischemic Stroke, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This study aims to construct a registry platform for microcirculatory disorders in a large sample of Chinese patients with cerebral small vessel disease and ischemic stroke; To explore the role of microcirculatory disorders in different types of cerebral small vessel disease and iachemic stroke, as well as their… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Small Vessel Diseases, Ischemic Stroke
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Study 1: Patients with acute ischemic stroke. Study 2: Patients with ischemic stroke during the recovery period. Study 3: Patients with cerebral small vessel disease based on STRIVE classification.
Who may be able to join
- Study 1:
- Age ≥ 18 years old.
- Acute ischemic stroke within 7 days of onset.
- Sign an informed consent form.
- Study 2:
- Age ≥ 18 years old.
Show all 16Show fewer
- Ischemic stroke during recovery period, within 30 days to 1 year of onset.
- Sign an informed consent form.
- Study 3:
- Age ≥ 18 years old.
- Within 3 years, there are characteristic lesions of cerebral small vessel disease on head MRI or CT, and they meet at least one of the following criteria:
- Paraventricular or deep white matter hyperintensities, Fazekas total score ≥ 2;
- Paraventricular or deep white matter hyperintensities, Fazekas total score=1, and at least two vascular risk factors (hypertension, hyperlipidemia, diabetes, current smoking, obesity, history of coronary heart disease, history of stroke).
- Paraventricular or deep white matter hyperintensities, Fazekas total score=1, with ≥ 1 lacune.
- New recent subcortical small infarcts.
- Sign an informed consent form.
Who cannot join
- Study 1:
- Cerebral hemorrhage and subarachnoid hemorrhage within 3 months of onset.
- There are untreated cerebral vascular malformations or untreated aneurysms (diameter>3mm).
- Confirmed neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, Parkinson's syndrome, etc.
- A mental illness diagnosed according to the DSM-V diagnostic criteria.
- There are clear diagnoses of non-vascular white matter lesions, such as multiple sclerosis, adult white matter dysplasia, metabolic encephalopathy, etc.
Show all 24Show fewer
- Unable to cooperate in completing follow-up visits due to geographical or other reasons.
- The patient also participated in other clinical trials.
- Study 2:
- Cerebral hemorrhage and subarachnoid hemorrhage within 3 months of onset.
- There are untreated cerebral vascular malformations or untreated aneurysms (diameter>3mm).
- Confirmed neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, Parkinson's syndrome, etc.
- A mental illness diagnosed according to the DSM-V diagnostic criteria.
- There are clear diagnoses of non-vascular white matter lesions, such as multiple sclerosis, adult white matter dysplasia, metabolic encephalopathy, etc.
- Unable to cooperate in completing follow-up visits due to geographical or other reasons.
- The patient also participated in other clinical trials.
- Study 3:
- Cerebral hemorrhage and subarachnoid hemorrhage within 3 months of onset.
- There are untreated cerebral vascular malformations or untreated aneurysms (diameter>3mm).
- Confirmed neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, Parkinson's syndrome, etc.
- A mental illness diagnosed according to the DSM-V diagnostic criteria.
- There are clear diagnoses of non-vascular white matter lesions, such as multiple sclerosis, adult white matter dysplasia, metabolic encephalopathy, etc.
- Unable to cooperate in completing follow-up visits due to geographical or other reasons.
- The patient also participated in other clinical trials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Registry Study of Microcirculation Disorder After Cerebral Small Vessel Disease and Ischemic Stroke, MODEST, Research Protocol
This study aims to construct a registry platform for microcirculatory disorders in a large sample of Chinese patients with cerebral small vessel disease and ischemic stroke; To explore the role of microcirculatory disorders in different types of cerebral small vessel disease and iachemic stroke, as well as their pathogenesis, severity, and prognosis; And to research on the drug treatment of microcirculatory disorders for cerebral small vessel disease and stroke in the real world.
Read the detailed description
Cerebral small vessel disease (CSVD) is a clinical syndrome with imaging and pathological changes, which is caused by various structural abnormality or functional dysfunction of small blood vessels including cerebral arterioles, perforating arteries, capillaries, and venules. It is also a common cause of stroke. Among people over 60 years old, the prevalence of CSVD exceeds 80%, and it is speculated that the number of CSVD patients in China exceeds 200 million, far higher than the number of stroke patients. CSVD can cause about 20% of stroke and 50% of dementia, while also doubling the risk of dementia and death, and tripling the risk of stroke. It is an important cause of death and disability in elderly people in China.
Stroke is a kind of cerebrovascular diseases characterized by sudden localized or diffuse neurological deficits caused by cerebral blood circulation disorders, and is the main clinical phenotype of cerebrovascular diseases. Stroke is characterized by high incidence rate, high disability rate, high mortality, high recurrence rate, and high economic burden. It is the first cause of death and disability in adult in China.
Microcirculatory disorders may play an important role in the pathophysiological process of ischemic CSVD. The pathological process of CSVD involves various components of the neurovascular units, including the blood-brain barrier composed of vascular endothelial cells, basement membrane, pericytes, and astrocytes, as well as oligodendrocytes, neurons, and extracellular matrix, etc.Among them, the disruption of the blood-brain barrier and endothelial damage are considered to be the initial stage of the pathological process of CSVD, causing the destruction of various secondary microcirculation structures and functions, namely the occurrence of microcirculatory disorders.
Microcirculatory disorders may also play a major role in the occurrence and development of ischemic cerebrovascular disease. By exploring multiple omics markers such as specific molecular biological markers related to ischemic cerebrovascular disease in the pathophysiological pathways of microcirculatory disorders, traditional risk factors and imaging markers can be combined to create prediction models for ineffective reperfusion of acute ischemic stroke and progression of CSVD, providing scientific evidence for improving the prognosis of acute ischemic stroke and CSVD.
- Conditions
- Cerebral Small Vessel Diseases, Ischemic Stroke
- Keywords
- Cerebral Small Vessel Diseases, Ischemic Stroke, Microcirculation Disorder, Multicenter Study, Registry Study
- Medical subject headings
- Cerebral Small Vessel Diseases, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Registry Study on Microcirculatory Disorders in Acute Ischemic Stroke | Establish a Chinese registry platform for microcirculatory disorders after acute ischemic stroke; use this registry platform to record the prevalence, diagnosis and treatment information, and prognosis of microcirculatory disorders after acute ischemic stroke. | |
| Registry Study on Microcirculatory Disorders in Ischemic Stroke during Recovery Period | Establish a national registry platform for microcirculatory disorders in ischemic stroke during recovery period; use this registry platform to record the prevalence, diagnosis and treatment information, and prognosis of microcirculatory disorders in ischemic stroke during recovery period. | |
| Registry Study on Microcirculatory Disorders in CSVD | Establish a national registry platform for microcirculatory disorders in CSVD; use this registry platform to record the prevalence, diagnosis and treatment information, and disease outcome of microcirculatory disorders in CSVD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between microcirculatory disorders and recurrence of stroke (ischemic stroke and hemorrhagic stroke)
This study will collect disease information related to microcirculatory disorders and recurrent stroke among patients with acute ischemic stroke.
Measured: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
Correlation between microcirculatory disorders and daily living ability levels (mRS) in patients with acute ischemic stroke
This study will collect disease information related to microcirculatory disorders and mRS among ischemic stroke patients during recovery period.
Measured: baseline, 3rd month, 6th month, 12th month, 18th month, 24th month
The correlation between microcirculatory disorders and cognitive function in CSVD (Mini COG).
This study will collect disease information related to microcirculatory disorders and Mini COG among patients with CSVD.
Measured: baseline, 3th month, 12th month
Secondary outcomes (15)
The drug treatment of acute ischemic stroke in the real world based on microcirculation disorders.
Record all the medication treatment information during the follow-up period since the last visit, and all the medications information is collated to describe the patient's medication regimen.
Measured: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
The correlation between microcirculatory disorders and the combination of vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction, vascular death) in the recovery period of ischemic stroke.
This study will collect Major Adverse Cardiovascular Events (MACE): including ischemic stroke, hemorrhagic stroke, myocardial infarction, and vascular death.
Measured: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
The correlation between microcirculatory disorders and the pathogenesis of acute ischemic stroke with different etiological subtypes.
Record the final diagnosis and main combined diagnosis of this enrollment event and complete blood laboratory examination, transcranial doppler ultrasound examination, physical examination and the like to ensure and evaluate the correlation between microcirculatory disorders and the pathogenesis of recovery ischemic stroke in different etiological subtypes.
Measured: baseline, 3rd month, 12th month
The correlation between microcirculation disorders and the severity of acute ischemic stroke.
This study will collect disease information related to microcirculatory disorders among patients with acute ischemic stroke to evaluate the correlation between microcirculation disorders and the severity of acute ischemic stroke.
Measured: baseline, 3rd month, 12th month
An effective treatment method for microcirculatory dysfunction targets in acute ischemic stroke.
Record the medication treatment information during the follow-up period since the last visit, to explore and build an effective treatment method for microcirculatory dysfunction targets in acute ischemic stroke.
Measured: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
The drug treatment of ischemic stroke in the recovery period based on microcirculation disorders in the real world.
Record the medication treatment information during the follow-up period since the last visit, including antiplatelet therapy, antihypertensive therapy, lipid-lowering, hypoglycemic, vasoactive drugs, neuroprotective agents, traditional Chinese medicine, etc. Detailed records of medication types, daily dosage, and duration are required.
Measured: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
The correlation between microcirculatory disorders and the pathogenesis of ischemic stroke during recovery period classified by different etiological subtypes.
Record the final diagnosis and main combined diagnosis of this enrollment event and complete blood laboratory examination, transcranial doppler ultrasound examination, physical examination and the like to ensure and evaluate the correlation between microcirculatory disorders and the pathogenesis of recovery ischemic stroke in different etiological subtypes.
Measured: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
The correlation between microcirculatory disorders and the severity of ischemic stroke during recovery period.
This study will collect disease information related to microcirculatory disorders and ischemic stroke patients during recovery period to evaluate the correlation between microcirculation disorders and the severity of ischemic stroke.
Measured: baseline, 3rd month, 12th month
An effective treatment method for microcirculatory dysfunction targets in the recovery stage of ischemic stroke.
Record the medication treatment information during the follow-up period since the last visit, to explore and build an effective treatment method for microcirculatory dysfunction targets in the recovery stage of ischemic stroke.
Measured: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
The correlation between microcirculatory disorders and the outcome/prognosis of ischemic stroke during recovery period.
This study will collect disease information related to microcirculatory disorders and mRS among ischemic stroke patients during recovery period to assess the correlation between microcirculatory disorders and the outcome/prognosis of ischemic stroke during recovery period.
Measured: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
The drug treatment of CSVD in the real world based on microcirculation disorders.
Record the medication treatment information during the follow-up period since the last visit, including antiplatelet therapy, antihypertensive therapy, lipid-lowering, hypoglycemic, vasoactive drugs, neuroprotective agents, traditional Chinese medicine, etc. Detailed records of medication types, daily dosage, and duration are required.
Measured: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
The correlation between microcirculatory disorders and the pathogenesis of different subtypes of CSVD.
Record the final diagnosis and main combined diagnosis of this enrollment event and complete blood laboratory examination, transcranial doppler ultrasound examination, physical examination and the like to ensure and evaluate the correlation between microcirculatory disorders and the pathogenesis of different subtypes of CSVD.
Measured: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
The correlation between microcirculatory disorders and the severity of CSVD.
This study will collect disease information related to microcirculatory disorders and CSVD to evaluate the correlation between microcirculation disorders and the severity of CSVD.
Measured: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
Effective treatment methods for microcirculatory disorders in CSVD.
Record the medication treatment information during the follow-up period since the last visit, to explore and build an effective treatment method for microcirculatory dysfunction targets in the CSVD.
Measured: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
The correlation between microcirculatory disorders and clinical symptoms of CSVD.
This study will complete and collect relevant information of clinical symptoms and microcirculatory disorders among patients with CSVD.
Measured: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start30 Oct 2023 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Cerebral Small Vessel DiseasesStudies 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
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yilong Wang, Beijing Tiantan Hospital
- Investigators
- Yilong Wang, PhD+MD, Principal investigator, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077305
- Sponsor's protocol ID
- KY2023-049-01
- Acronym
- MODEST
- Status last verified
- Oct 2023
- First submitted
- 21 Sep 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen Weiqi, Pan Yuesong, Chen Xia, Bai Feng, Cao Yongjun, Fan Yuhua, et al. Expert Consensus on Clinical Trial Design Standards for Cerebrovascular Disease Treatment Drugs. Chinese Journal of Stroke.2021;16:288-297
Hu Wenli, Yang Lei, Li Tingting, Huang Yonghua Consensus of Chinese Experts on the Diagnosis and Treatment of Cerebral small vessel disease 2021. Chinese Journal of Stroke 2021;16:716-726
van Veluw SJ, Shih AY, Smith EE, Chen C, Schneider JA, Wardlaw JM, Greenberg SM, Biessels GJ. Detection, risk factors, and functional consequences of cerebral microinfarcts. Lancet Neurol. 2017 Sep;16(9):730-740. doi: 10.1016/S1474-4422(17)30196-5. Epub 2017 Jul 14.
PubMed 28716371Debette S, Schilling S, Duperron MG, Larsson SC, Markus HS. Clinical Significance of Magnetic Resonance Imaging Markers of Vascular Brain Injury: A Systematic Review and Meta-analysis. JAMA Neurol. 2019 Jan 1;76(1):81-94. doi: 10.1001/jamaneurol.2018.3122.
PubMed 30422209Compilation team of the
De Silva TM, Faraci FM. Contributions of Aging to Cerebral Small Vessel Disease. Annu Rev Physiol. 2020 Feb 10;82:275-295. doi: 10.1146/annurev-physiol-021119-034338. Epub 2019 Oct 16.
PubMed 31618600Cuadrado-Godia E, Dwivedi P, Sharma S, Ois Santiago A, Roquer Gonzalez J, Balcells M, Laird J, Turk M, Suri HS, Nicolaides A, Saba L, Khanna NN, Suri JS. Cerebral Small Vessel Disease: A Review Focusing on Pathophysiology, Biomarkers, and Machine Learning Strategies. J Stroke. 2018 Sep;20(3):302-320. doi: 10.5853/jos.2017.02922. Epub 2018 Sep 30.
PubMed 30309226Ter Telgte A, van Leijsen EMC, Wiegertjes K, Klijn CJM, Tuladhar AM, de Leeuw FE. Cerebral small vessel disease: from a focal to a global perspective. Nat Rev Neurol. 2018 Jul;14(7):387-398. doi: 10.1038/s41582-018-0014-y.
PubMed 29802354Litak J, Mazurek M, Kulesza B, Szmygin P, Litak J, Kamieniak P, Grochowski C. Cerebral Small Vessel Disease. Int J Mol Sci. 2020 Dec 20;21(24):9729. doi: 10.3390/ijms21249729.
PubMed 33419271Uemura MT, Maki T, Ihara M, Lee VMY, Trojanowski JQ. Brain Microvascular Pericytes in Vascular Cognitive Impairment and Dementia. Front Aging Neurosci. 2020 Apr 14;12:80. doi: 10.3389/fnagi.2020.00080. eCollection 2020.
PubMed 32317958Low A, Mak E, Rowe JB, Markus HS, O'Brien JT. Inflammation and cerebral small vessel disease: A systematic review. Ageing Res Rev. 2019 Aug;53:100916. doi: 10.1016/j.arr.2019.100916. Epub 2019 Jun 10.
PubMed 31181331Shi Y, Thrippleton MJ, Makin SD, Marshall I, Geerlings MI, de Craen AJM, van Buchem MA, Wardlaw JM. Cerebral blood flow in small vessel disease: A systematic review and meta-analysis. J Cereb Blood Flow Metab. 2016 Oct;36(10):1653-1667. doi: 10.1177/0271678X16662891. Epub 2016 Aug 5.
PubMed 27496552Montenont E, Rondina MT, Campbell RA. Altered functions of platelets during aging. Curr Opin Hematol. 2019 Sep;26(5):336-342. doi: 10.1097/MOH.0000000000000526.
PubMed 31348047Hussein HM, Georgiadis AL, Vazquez G, Miley JT, Memon MZ, Mohammad YM, Christoforidis GA, Tariq N, Qureshi AI. Occurrence and predictors of futile recanalization following endovascular treatment among patients with acute ischemic stroke: a multicenter study. AJNR Am J Neuroradiol. 2010 Mar;31(3):454-8. doi: 10.3174/ajnr.A2006. Epub 2010 Jan 14.
PubMed 20075087Hussein HM, Saleem MA, Qureshi AI. Rates and predictors of futile recanalization in patients undergoing endovascular treatment in a multicenter clinical trial. Neuroradiology. 2018 May;60(5):557-563. doi: 10.1007/s00234-018-2016-2. Epub 2018 Mar 25.
PubMed 29574600
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry Study of Microcirculation Disorder After Cerebral Small Vessel Disease and Ischemic Stroke, MODEST, Research Protocol
- ClinicalTrials.gov ID
- NCT06077305
- Acronym / sponsor ID
- MODEST / KY2023-049-01
- Conditions
- Cerebral Small Vessel Diseases, Ischemic Stroke
- Keywords
- Cerebral Small Vessel Diseases, Ischemic Stroke, Microcirculation Disorder, Multicenter Study, Registry Study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 30 Oct 2023 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Oct 2023 (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 aims to construct a registry platform for microcirculatory disorders in a large sample of Chinese patients with cerebral small vessel disease and ischemic stroke; To explore the role of microcirculatory disorders in different types of cerebral small vessel disease and iachemic stroke, as well as their pathogenesis, severity, and prognosis; And to research on the drug treatment of microcirculatory disorders for cerebral small vessel disease and stroke in the real world.
Detailed description
Cerebral small vessel disease (CSVD) is a clinical syndrome with imaging and pathological changes, which is caused by various structural abnormality or functional dysfunction of small blood vessels including cerebral arterioles, perforating arteries, capillaries, and venules. It is also a common cause of stroke. Among people over 60 years old, the prevalence of CSVD exceeds 80%, and it is speculated that the number of CSVD patients in China exceeds 200 million, far higher than the number of stroke patients. CSVD can cause about 20% of stroke and 50% of dementia, while also doubling the risk of dementia and death, and tripling the risk of stroke. It is an important cause of death and disability in elderly people in China.
Stroke is a kind of cerebrovascular diseases characterized by sudden localized or diffuse neurological deficits caused by cerebral blood circulation disorders, and is the main clinical phenotype of cerebrovascular diseases. Stroke is characterized by high incidence rate, high disability rate, high mortality, high recurrence rate, and high economic burden. It is the first cause of death and disability in adult in China.
Microcirculatory disorders may play an important role in the pathophysiological process of ischemic CSVD. The pathological process of CSVD involves various components of the neurovascular units, including the blood-brain barrier composed of vascular endothelial cells, basement membrane, pericytes, and astrocytes, as well as oligodendrocytes, neurons, and extracellular matrix, etc.Among them, the disruption of the blood-brain barrier and endothelial damage are considered to be the initial stage of the pathological process of CSVD, causing the destruction of various secondary microcirculation structures and functions, namely the occurrence of microcirculatory disorders.
Microcirculatory disorders may also play a major role in the occurrence and development of ischemic cerebrovascular disease. By exploring multiple omics markers such as specific molecular biological markers related to ischemic cerebrovascular disease in the pathophysiological pathways of microcirculatory disorders, traditional risk factors and imaging markers can be combined to create prediction models for ineffective reperfusion of acute ischemic stroke and progression of CSVD, providing scientific evidence for improving the prognosis of acute ischemic stroke and CSVD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Registry Study on Microcirculatory Disorders in Acute Ischemic Stroke | – | –Establish a Chinese registry platform for microcirculatory disorders after acute ischemic stroke; use this registry platform to record the prevalence, diagnosis and treatment information, and prognosis of microcirculatory disorders after acute ischemic stroke. |
| Registry Study on Microcirculatory Disorders in Ischemic Stroke during Recovery Period | – | –Establish a national registry platform for microcirculatory disorders in ischemic stroke during recovery period; use this registry platform to record the prevalence, diagnosis and treatment information, and prognosis of microcirculatory disorders in ischemic stroke during recovery period. |
| Registry Study on Microcirculatory Disorders in CSVD | – | –Establish a national registry platform for microcirculatory disorders in CSVD; use this registry platform to record the prevalence, diagnosis and treatment information, and disease outcome of microcirculatory disorders in CSVD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Study 1: Patients with acute ischemic stroke. Study 2: Patients with ischemic stroke during the recovery period. Study 3: Patients with cerebral small vessel disease based on STRIVE classification.
Key inclusion criteria (16 listed)
- Age ≥ 18 years old.
- Acute ischemic stroke within 7 days of onset.
- Sign an informed consent form.
- Age ≥ 18 years old.
- Ischemic stroke during recovery period, within 30 days to 1 year of onset.
Key exclusion criteria (24 listed)
- Cerebral hemorrhage and subarachnoid hemorrhage within 3 months of onset.
- There are untreated cerebral vascular malformations or untreated aneurysms (diameter>3mm).
- Confirmed neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, Parkinson's syndrome, etc.
- A mental illness diagnosed according to the DSM-V diagnostic criteria.
- There are clear diagnoses of non-vascular white matter lesions, such as multiple sclerosis, adult white matter dysplasia, metabolic encephalopathy, etc.
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
The correlation between microcirculatory disorders and recurrence of stroke (ischemic stroke and hemorrhagic stroke)
Time frame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
This study will collect disease information related to microcirculatory disorders and recurrent stroke among patients with acute ischemic stroke.
Correlation between microcirculatory disorders and daily living ability levels (mRS) in patients with acute ischemic stroke
Time frame: baseline, 3rd month, 6th month, 12th month, 18th month, 24th month
This study will collect disease information related to microcirculatory disorders and mRS among ischemic stroke patients during recovery period.
The correlation between microcirculatory disorders and cognitive function in CSVD (Mini COG).
Time frame: baseline, 3th month, 12th month
This study will collect disease information related to microcirculatory disorders and Mini COG among patients with CSVD.
15 secondary outcomes
The drug treatment of acute ischemic stroke in the real world based on microcirculation disorders.
Time frame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
The correlation between microcirculatory disorders and the combination of vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction, vascular death) in the recovery period of ischemic stroke.
Time frame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
The correlation between microcirculatory disorders and the pathogenesis of acute ischemic stroke with different etiological subtypes.
Time frame: baseline, 3rd month, 12th month
The correlation between microcirculation disorders and the severity of acute ischemic stroke.
Time frame: baseline, 3rd month, 12th month
An effective treatment method for microcirculatory dysfunction targets in acute ischemic stroke.
Time frame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
The drug treatment of ischemic stroke in the recovery period based on microcirculation disorders in the real world.
Time frame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
The correlation between microcirculatory disorders and the pathogenesis of ischemic stroke during recovery period classified by different etiological subtypes.
Time frame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
The correlation between microcirculatory disorders and the severity of ischemic stroke during recovery period.
Time frame: baseline, 3rd month, 12th month
An effective treatment method for microcirculatory dysfunction targets in the recovery stage of ischemic stroke.
Time frame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
The correlation between microcirculatory disorders and the outcome/prognosis of ischemic stroke during recovery period.
Time frame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
The drug treatment of CSVD in the real world based on microcirculation disorders.
Time frame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
The correlation between microcirculatory disorders and the pathogenesis of different subtypes of CSVD.
Time frame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
The correlation between microcirculatory disorders and the severity of CSVD.
Time frame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
Effective treatment methods for microcirculatory disorders in CSVD.
Time frame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
The correlation between microcirculatory disorders and clinical symptoms of CSVD.
Time frame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Results publicationChen Weiqi, Pan Yuesong, Chen Xia, Bai Feng, Cao Yongjun, Fan Yuhua, et al. Expert Consensus on Clinical Trial Design Standards for Cerebrovascular Disease Treatment Drugs. Chinese Journal of Stroke.2021;16:288-297
- Results publicationHu Wenli, Yang Lei, Li Tingting, Huang Yonghua Consensus of Chinese Experts on the Diagnosis and Treatment of Cerebral small vessel disease 2021. Chinese Journal of Stroke 2021;16:716-726
- Results publication: PubMed 28716371van Veluw SJ, Shih AY, Smith EE, Chen C, Schneider JA, Wardlaw JM, Greenberg SM, Biessels GJ. Detection, risk factors, and functional consequences of cerebral microinfarcts. Lancet Neurol. 2017 Sep;16(9):730-740. doi: 10.1016/S1474-4422(17)30196-5. Epub 2017 Jul 14.
- Results publication: PubMed 30422209Debette S, Schilling S, Duperron MG, Larsson SC, Markus HS. Clinical Significance of Magnetic Resonance Imaging Markers of Vascular Brain Injury: A Systematic Review and Meta-analysis. JAMA Neurol. 2019 Jan 1;76(1):81-94. doi: 10.1001/jamaneurol.2018.3122.
- Results publicationCompilation team of the
- Results publication: PubMed 31618600De Silva TM, Faraci FM. Contributions of Aging to Cerebral Small Vessel Disease. Annu Rev Physiol. 2020 Feb 10;82:275-295. doi: 10.1146/annurev-physiol-021119-034338. Epub 2019 Oct 16.
- Results publication: PubMed 30309226Cuadrado-Godia E, Dwivedi P, Sharma S, Ois Santiago A, Roquer Gonzalez J, Balcells M, Laird J, Turk M, Suri HS, Nicolaides A, Saba L, Khanna NN, Suri JS. Cerebral Small Vessel Disease: A Review Focusing on Pathophysiology, Biomarkers, and Machine Learning Strategies. J Stroke. 2018 Sep;20(3):302-320. doi: 10.5853/jos.2017.02922. Epub 2018 Sep 30.
- Results publication: PubMed 29802354Ter Telgte A, van Leijsen EMC, Wiegertjes K, Klijn CJM, Tuladhar AM, de Leeuw FE. Cerebral small vessel disease: from a focal to a global perspective. Nat Rev Neurol. 2018 Jul;14(7):387-398. doi: 10.1038/s41582-018-0014-y.
- Results publication: PubMed 33419271Litak J, Mazurek M, Kulesza B, Szmygin P, Litak J, Kamieniak P, Grochowski C. Cerebral Small Vessel Disease. Int J Mol Sci. 2020 Dec 20;21(24):9729. doi: 10.3390/ijms21249729.
- Results publication: PubMed 32317958Uemura MT, Maki T, Ihara M, Lee VMY, Trojanowski JQ. Brain Microvascular Pericytes in Vascular Cognitive Impairment and Dementia. Front Aging Neurosci. 2020 Apr 14;12:80. doi: 10.3389/fnagi.2020.00080. eCollection 2020.
- Results publication: PubMed 31181331Low A, Mak E, Rowe JB, Markus HS, O'Brien JT. Inflammation and cerebral small vessel disease: A systematic review. Ageing Res Rev. 2019 Aug;53:100916. doi: 10.1016/j.arr.2019.100916. Epub 2019 Jun 10.
- Results publication: PubMed 27496552Shi Y, Thrippleton MJ, Makin SD, Marshall I, Geerlings MI, de Craen AJM, van Buchem MA, Wardlaw JM. Cerebral blood flow in small vessel disease: A systematic review and meta-analysis. J Cereb Blood Flow Metab. 2016 Oct;36(10):1653-1667. doi: 10.1177/0271678X16662891. Epub 2016 Aug 5.
- 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.
Yilong Wang, PhD+MD principal investigator
Beijing Tiantan Hospital, Capital Medical University, Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Small Vessel Diseases and Ischemic Stroke, run by Beijing Tiantan Hospital at 1 site 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 16 inclusion and 24 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: opening soon, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yilong Wang, PhD+MD (0086-010-67092222 ext. 0, yilong528@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between microcirculatory disorders and recurrence of stroke (ischemic stroke and hemorrhagic stroke) (time frame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month). The study lists 3 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 NCT06077305, which also lists 23 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 Oct 2023.