The Long-term Effect of Remote Ischemic Conditioning on Main Organs in ASVCD Patients With Very High Risks

ConditionASCVD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorGeneral Hospital of Shenyang Military Region

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

2,800 Participants
are divided into 2 treatment groups
Group A: RIC group1 intervention
Group B: Control group0 interventions

Trial outcomes

Primary outcomes

1

Incidence of Composite Endpoint Events

including cardiovascular events, stroke, vascular death, and deterioration of renal function.

Time frame
1 year

Secondary outcomes

1

Number of participants with no-fatal cardiovascular events

Time frame
1 year
2

Number of participants with no-fatal stroke

Time frame
1 year
3

Number of participants with no-fatal deterioration of renal function

Time frame
1 year
4

Change of renal function

renal function was meausred by serum urea nitrogen and creatinine

Time frame
1 year

Other outcomes

1

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.

Time frame
1 year
2

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

Time frame
1 year
3

Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9)

range from 0-27, higher score meaning worse symptoms

Time frame
1 year
4

Anxiety symptoms measured by the Generalized Anxiety Disorder-7 (GAD-7)

range from 0-21, higher score meaning worse symptoms

Time frame
1 year

Sponsors and contacts

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