A Registry Study of Microcirculation Disorder After Cerebral Small Vessel Disease and Ischemic Stroke

NCT06077305 | Not Yet Recruiting DMC

• 1 other identifier: KY2023-049-01
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Small Vessel Diseases; Ischemic Stroke

Keywords

Cerebral Small Vessel Diseases; Ischemic Stroke; Microcirculation Disorder; Multicenter Study; Registry Study

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  baseline, 3th month, 12th month

Secondary Outcomes (15)

• The drug treatment of acute ischemic stroke in the real world based on microcirculation disorders.

  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.

  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.

  baseline, 3rd month, 12th month

• The correlation between microcirculation disorders and the severity of acute ischemic stroke.

  baseline, 3rd month, 12th month

• An effective treatment method for microcirculatory dysfunction targets in acute ischemic stroke.

  baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, 100050, China

Location

Related Publications (23)

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• 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

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• Compilation team of the

  RESULT

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  RESULT

MeSH Terms

Conditions

Cerebral Small Vessel Diseases; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke

Study Officials

• Yilong Wang, PhD+MD

  Beijing Tiantan Hospital, Capital Medical University, Beijing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yilong Wang, PhD+MD

CONTACT

0086-010-67092222; yilong528@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Beijing Tiantan Hospital

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 11, 2023
• Study Start: October 30, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)