About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Age ≥65 y
Disqualifiers
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
Trial population
very high-risk ASCVD populations
Trial design
Cohort
Prospective
Treatments tested in this trial
remote ischemic conditioning
Device5 cycles of cuff inflation for 5 minutes and deflation for 5 minutes to the bilateral upper limbs to 200 mmHg
Treatment groups
Trial outcomes
Primary outcomes
Incidence of Composite Endpoint Events
including cardiovascular events, stroke, vascular death, and deterioration of renal function.
Secondary outcomes
Number of participants with no-fatal cardiovascular events
Number of participants with no-fatal stroke
Number of participants with no-fatal deterioration of renal function
Change of renal function
renal function was meausred by serum urea nitrogen and creatinine
Other outcomes
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.
Changes in cognitive function measured by MoCA and MMSE
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
Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9)
range from 0-27, higher score meaning worse symptoms
Anxiety symptoms measured by the Generalized Anxiety Disorder-7 (GAD-7)
range from 0-21, higher score meaning worse symptoms
Sponsors and contacts
Click on the lead sponsor to view all of their trials.