ASCVDNCT07270887
The Long-term Effect of Remote Ischemic Conditioning on Main Organs in ASVCD Patients With Very High Risks
An observational study of ASCVD, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- ASCVD
- What is being tested?
- remote ischemic conditioning
- Type of treatment
- Medical device
- How many people
- 2,800 participants
- Where
- 1 siteChina
- Study dates
- 19 Nov 2025to 30 Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Adult, Older adult
Study population: very high-risk ASCVD populations
Who may be able to join
- 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:
- Acute coronary syndrome within the past year. B. History of myocardial infarction (not part of a new acute coronary syndrome episode).
- 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.
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- Risk factors:
- Age ≥65 y
- Heterozygous familial hypercholesterolemia
- History of prior coronary artery bypass surgery or percutaneous coronary intervention outside of the major
- ASCVD event(s)
- Diabetes mellitus
- Hypertension
- CKD (eGFR 15-59 mL/min/1.73 m2)
- Current smoking
- Persistently elevated LDL-C (LDL-C ≥100 mg/dL [≥2.6 mmol/L]) despite maximally tolerated statin therapy and ezetimibe
- History of congestive HF
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, 110016
Hui-Sheng Chen, Ph.D., +86 13352452086, chszh@aliyun.com
About this study
Official title: The Long-term Effect of Remote Ischemic Conditioning on Main Organs in ASVCD Patients With Very High Risks (RICMO-ASCVD): a Prospective, Blinded Endpoint, Multi-center, Cohort Study
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.
- Conditions
- ASCVD
- Being tested
- remote ischemic conditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote ischemic conditioningDevice
5 cycles of cuff inflation for 5 minutes and deflation for 5 minutes to the bilateral upper limbs to 200 mmHg
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: remote ischemic conditioning | |
| Control group | The patients will only receive guideline-based treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Composite Endpoint Events
including cardiovascular events, stroke, vascular death, and deterioration of renal function.
Measured: 1 year
Secondary outcomes (10)
Number of participants with no-fatal cardiovascular events
Measured: 1 year
Number of participants with no-fatal stroke
Measured: 1 year
Number of participants with no-fatal deterioration of renal function
Measured: 1 year
Change of renal function
renal function was meausred by serum urea nitrogen and creatinine
Measured: 1 year
Change of blood pressure
Measured: 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 %)
Measured: 1 year
Number of participants with new onset diabetes
Measured: 1 year
Occurence of vascular death
Measured: 1 year
Barthel Index (BI) scores
BI ranges from 0-100, higher scores meaning a better outcome.
Measured: 1 year
Death due to all causes
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start19 Nov 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASCVDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,800 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270887
- Sponsor's protocol ID
- Y (2025) 394
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Effect of Remote Ischemic Conditioning on Main Organs in ASVCD Patients With Very High Risks (RICMO-ASCVD): a Prospective, Blinded Endpoint, Multi-center, Cohort Study
- ClinicalTrials.gov ID
- NCT07270887
- Acronym / sponsor ID
- Y (2025) 394
- Conditions
- ASCVD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,800 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC group | – | Device: remote ischemic conditioningThe 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- very high-risk ASCVD populations
Key inclusion criteria (17 listed)
- 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
- Acute coronary syndrome within the past year. B. History of myocardial infarction (not part of a new acute coronary syndrome episode).
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remote ischemic conditioning5 cycles of cuff inflation for 5 minutes and deflation for 5 minutes to the bilateral upper limbs to 200 mmHg | Device | RIC group |
Primary outcome
Incidence of Composite Endpoint Events
Time frame: 1 year
including cardiovascular events, stroke, vascular death, and deterioration of renal function.
10 secondary outcomes
Number of participants with no-fatal cardiovascular events
Time frame: 1 year
Number of participants with no-fatal stroke
Time frame: 1 year
Number of participants with no-fatal deterioration of renal function
Time frame: 1 year
Change of renal function
Time frame: 1 year
Change of blood pressure
Time frame: 1 year
Changes in serological indicators such as blood glucose, blood lipids, and glycated hemoglobin (HbA1c)
Time frame: 1 year
Number of participants with new onset diabetes
Time frame: 1 year
Occurence of vascular death
Time frame: 1 year
Barthel Index (BI) scores
Time frame: 1 year
Death due to all causes
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ASCVD, run by General Hospital of Shenyang Military Region at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Composite Endpoint Events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.