Ischemic Stroke Clinical Trial
— MODESTOfficial 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.
Status | Not yet recruiting |
Enrollment | 20000 |
Est. completion date | December 31, 2026 |
Est. primary completion date | October 31, 2026 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Tiantan Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Tiantan Hospital |
China,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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. | baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month | |
Secondary | 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. | baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month | |
Secondary | 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. | baseline, 3rd month, 12th month | |
Secondary | 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. | baseline, 3rd month, 12th month | |
Secondary | 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. | baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month | |
Secondary | 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. | baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month | |
Secondary | 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. | baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month | |
Secondary | 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. | baseline, 3rd month, 12th month | |
Secondary | 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. | baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month | |
Secondary | 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. | baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month | |
Secondary | 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. | baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month | |
Secondary | 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. | baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month | |
Secondary | 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. | baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month | |
Secondary | 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. | baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month | |
Secondary | 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. | baseline, 14th day, 3rd month, 6th month, 12th month, 18th month, 24th month |
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