Clinical trial NCT06077305: A Registry Study of Microcirculation Disorder After Cerebral Small Vessel Disease and Ischemic Stroke
Official title: A Registry Study of Microcirculation Disorder After Cerebral Small Vessel Disease and Ischemic Stroke, MODEST, Research Protocol
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cerebral Small Vessel Diseases
Ischemic Stroke
Keywords: Cerebral Small Vessel Diseases
Ischemic Stroke
Microcirculation Disorder
Multicenter Study
Registry Study
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

Study 1:

1. Age ≥ 18 years old.
2. Acute ischemic stroke within 7 days of onset.
3. Sign an informed consent form.

Study 2:

1. Age ≥ 18 years old.
2. Ischemic stroke during recovery period, within 30 days to 1 year of onset.
3. Sign an informed consent form.

Study 3:

1. Age ≥ 18 years old.
2. 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:

   1. Paraventricular or deep white matter hyperintensities, Fazekas total score ≥ 2;
   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).
   3. Paraventricular or deep white matter hyperintensities, Fazekas total score=1, with ≥ 1 lacune.
   4. New recent subcortical small infarcts.
3. Sign an informed consent form.

Exclusion Criteria:

Study 1:

1. Cerebral hemorrhage and subarachnoid hemorrhage within 3 months of onset.
2. There are untreated cerebral vascular malformations or untreated aneurysms (diameter\>3mm).
3. Confirmed neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, Parkinson's syndrome, etc.
4. A mental illness diagnosed according to the DSM-V diagnostic criteria.
5. There are clear diagnoses of non-vascular white matter lesions, such as multiple sclerosis, adult white matter dysplasia, metabolic encephalopathy, etc.
6. Unable to cooperate in completing follow-up visits due to geographical or other reasons.
7. The patient also participated in other clinical trials.

Study 2:

1. Cerebral hemorrhage and subarachnoid hemorrhage within 3 months of onset.
2. There are untreated cerebral vascular malformations or untreated aneurysms (diameter\>3mm).
3. Confirmed neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, Parkinson's syndrome, etc.
4. A mental illness diagnosed according to the DSM-V diagnostic criteria.
5. There are clear diagnoses of non-vascular white matter lesions, such as multiple sclerosis, adult white matter dysplasia, metabolic encephalopathy, etc.
6. Unable to cooperate in completing follow-up visits due to geographical or other reasons.
7. The patient also participated in other clinical trials.

Study 3:

1. Cerebral hemorrhage and subarachnoid hemorrhage within 3 months of onset.
2. There are untreated cerebral vascular malformations or untreated aneurysms (diameter\>3mm).
3. Confirmed neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, Parkinson's syndrome, etc.
4. A mental illness diagnosed according to the DSM-V diagnostic criteria.
5. There are clear diagnoses of non-vascular white matter lesions, such as multiple sclerosis, adult white matter dysplasia, metabolic encephalopathy, etc.
6. Unable to cooperate in completing follow-up visits due to geographical or other reasons.
7. The patient also participated in other clinical trials.

Primary outcomes:
measure: The correlation between microcirculatory disorders and recurrence of stroke (ischemic stroke and hemorrhagic stroke)
timeFrame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
measure: Correlation between microcirculatory disorders and daily living ability levels (mRS) in patients with acute ischemic stroke
timeFrame: baseline, 3rd month, 6th month, 12th month, 18th month, 24th month
measure: The correlation between microcirculatory disorders and cognitive function in CSVD (Mini COG).
timeFrame: baseline, 3th month, 12th month
Secondary outcomes:
measure: The drug treatment of acute ischemic stroke in the real world based on microcirculation disorders.
timeFrame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
measure: 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.
timeFrame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
measure: The correlation between microcirculatory disorders and the pathogenesis of acute ischemic stroke with different etiological subtypes.
timeFrame: baseline, 3rd month, 12th month
measure: The correlation between microcirculation disorders and the severity of acute ischemic stroke.
timeFrame: baseline, 3rd month, 12th month
measure: An effective treatment method for microcirculatory dysfunction targets in acute ischemic stroke.
timeFrame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
measure: The drug treatment of ischemic stroke in the recovery period based on microcirculation disorders in the real world.
timeFrame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
measure: The correlation between microcirculatory disorders and the pathogenesis of ischemic stroke during recovery period classified by different etiological subtypes.
timeFrame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
measure: The correlation between microcirculatory disorders and the severity of ischemic stroke during recovery period.
timeFrame: baseline, 3rd month, 12th month
measure: An effective treatment method for microcirculatory dysfunction targets in the recovery stage of ischemic stroke.
timeFrame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
measure: The correlation between microcirculatory disorders and the outcome/prognosis of ischemic stroke during recovery period.
timeFrame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
measure: The drug treatment of CSVD in the real world based on microcirculation disorders.
timeFrame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
measure: The correlation between microcirculatory disorders and the pathogenesis of different subtypes of CSVD.
timeFrame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
measure: The correlation between microcirculatory disorders and the severity of CSVD.
timeFrame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
measure: Effective treatment methods for microcirculatory disorders in CSVD.
timeFrame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
measure: The correlation between microcirculatory disorders and clinical symptoms of CSVD.
timeFrame: baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
affiliation: Beijing Tiantan Hospital, Capital Medical University, Beijing, China
name: Yilong Wang, PhD+MD
role: PRINCIPAL_INVESTIGATOR
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