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Atherosclerotic cardiovascular disease (ASCVD) is a group of disorders sharing atherosclerosis as a common pathological basis, primarily affecting the heart, brain, kidneys, and other peripheral arteries, leading to clinical syndromes characterized mainly by arterial ischemia. It has become the group of diseases with the highest morbidity and mortality rates worldwide. Patients with very high-risk ASCVD face an even greater risk of recurrence. Previous studies have discovered that remote ischemic conditioning (RIC) has protective effects on major organs such as the heart, brain, and kidneys. Given the cardiorenal and cerebrovascular protective effects of RIC, the invesitgators believe that long-term remote ischemic conditioning is a promising approach to preventing the recurrence of ASCVD events. Based on this hypothesis, the investigators have designed a prospective, multicenter cohort study with blinded outcome assessment to investigate the protective effects of long-term remote ischemic conditioning in very high-risk ASCVD populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIC group | The patients will receive treatment with RIC (5 cycles of cuff inflation for 5 minutes and deflation for 5 minutes to the bilateral upper limbs to 200 mmHg, twice daily) for 1 year as an adjunct to guideline-based treatment |
| |
| Control group | The patients will only receive guideline-based treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remote ischemic conditioning | Device | 5 cycles of cuff inflation for 5 minutes and deflation for 5 minutes to the bilateral upper limbs to 200 mmHg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Composite Endpoint Events | including cardiovascular events, stroke, vascular death, and deterioration of renal function. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with no-fatal cardiovascular events | 1 year | |
| Number of participants with no-fatal stroke | 1 year | |
| Number of participants with no-fatal deterioration of renal function |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in cerebral small vessel disease burden (CSVD) | The total CSVD score is calculated by the following four neuroimaging features on MRI: lacunes, white matter hyperintensities, cerebral microbleeds and perivascular spaces (PVS). The score ranges from 0-4, with high score meaning heavier burden. | 1 year |
| Changes in cognitive function measured by MoCA and MMSE |
Inclusion Criteria:
Note: Definition of Major ASCVD Events:
A. Acute coronary syndrome within the past year. B. History of myocardial infarction (not part of a new acute coronary syndrome episode).
C. Ischemic stroke or history of ischemic stroke. D. Symptomatic peripheral artery disease, defined as intermittent claudication with an ankle-brachial index (ABI) < 0.85, or prior limb revascularization or amputation.
Risk factors:
Exclusion Criteria:
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very high-risk ASCVD populations
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, General Hospital of Northern Theater Command | Recruiting | Shenyang | 110016 | China |
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| 1 year |
| Change of renal function | renal function was meausred by serum urea nitrogen and creatinine | 1 year |
| Change of blood pressure | 1 year |
| Changes in serological indicators such as blood glucose, blood lipids, and glycated hemoglobin (HbA1c) | Changes in the following serological indicators will be assessed and reported as separate outcome measures: Blood glucose (in mmol/L or mg/dL) Blood lipids [specify component, e.g., LDL-C, in mmol/L or mg/dL] Glycated hemoglobin (HbA1c) (in %) | 1 year |
| Number of participants with new onset diabetes | 1 year |
| Occurence of vascular death | 1 year |
| Barthel Index (BI) scores | BI ranges from 0-100, higher scores meaning a better outcome. | 1 year |
| Death due to all causes | 1 year |
The Montreal Cognitive Assessment (MoCA) (score range: 0-30) and The Mini-Mental State Examination (MMSE) (score range: 0-30), with higher score meaning better cognitive function |
| 1 year |
| Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9) | range from 0-27, higher score meaning worse symptoms | 1 year |
| Anxiety symptoms measured by the Generalized Anxiety Disorder-7 (GAD-7) | range from 0-21, higher score meaning worse symptoms | 1 year |
| Changes in cerebral autoregulation | cerebral autoregulation is measured by using TCD and Transfer Function Analysis | 1 year |