ASCVD
Conditions
Brief summary
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.
Interventions
DEVICEremote ischemic conditioning
5 cycles of cuff inflation for 5 minutes and deflation for 5 minutes to the bilateral upper limbs to 200 mmHg
Sponsors
General Hospital of Shenyang Military Region
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Inclusion criteria
* Age over 40 years * Two or more prior major ASCVD events; OR one documented major ASCVD event with two or more of the following risk factors * signed informed consent 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: 1. Age ≥65 y 2. Heterozygous familial hypercholesterolemia 3. History of prior coronary artery bypass surgery or percutaneous coronary intervention outside of the major 4. ASCVD event(s) 5. Diabetes mellitus 6. Hypertension 7. CKD (eGFR 15-59 mL/min/1.73 m2) 8. Current smoking 9. Persistently elevated LDL-C (LDL-C ≥100 mg/dL \[≥2.6 mmol/L\]) despite maximally tolerated statin therapy and ezetimibe 10. History of congestive HF
Exclusion criteria
* Presence of severe neurological deficit (mRS score ≥ 3) * Uncontrolled severe hypertension (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg despite medication) * Subclavian artery stenosis ≥ 50% or presence of subclavian steal syndrome * Severe hematological disorders or significant coagulation abnormalities * Contraindications to remote ischemic conditioning, such as severe soft tissue injury, fracture, or vascular injury in the upper limbs, or peripheral vascular disease in the distal upper limbs * Severe comorbid conditions with a life expectancy of less than 1 year * Participation in another clinical trial within the past 3 months or ongoing participation * Any other circumstances deemed by the investigator as unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Composite Endpoint Events | 1 year | including cardiovascular events, stroke, vascular death, and deterioration of renal function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of renal function | 1 year | renal function was meausred by serum urea nitrogen and creatinine |
| Changes in serological indicators such as blood glucose, blood lipids, and glycated hemoglobin (HbA1c) | 1 year | 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 %) |
| Number of participants with new onset diabetes | 1 year | — |
| Occurence of vascular death | 1 year | — |
| Barthel Index (BI) scores | 1 year | BI ranges from 0-100, higher scores meaning a better outcome. |
| Death due to all causes | 1 year | — |
| 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 | 1 year | — |
| Change of blood pressure | 1 year | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9) | 1 year | range from 0-27, higher score meaning worse symptoms |
| Anxiety symptoms measured by the Generalized Anxiety Disorder-7 (GAD-7) | 1 year | range from 0-21, higher score meaning worse symptoms |
| Changes in cerebral autoregulation | 1 year | cerebral autoregulation is measured by using TCD and Transfer Function Analysis |
| Changes in cognitive function measured by MoCA and MMSE | 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 |
| Changes in cerebral small vessel disease burden (CSVD) | 1 year | 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. |
Countries
China
Outcome results
None listed