Acute Myocardial InfarctionL-RICP-AMINCT07181356
Effects of Long-term Remote Ischemic Preconditioning on Clinical Outcome in Patients With Acute Myocardial Infarction
A study testing RIPerC and RIPC in people with Acute Myocardial Infarction, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.
Trial summary
At present, there are 290 million cardiovascular patients in China, including 11 million patients with coronary heart disease. Remote ischemic preconditioning(RIPC) may play an effective endogenous cardiac protection.This study will explore whether long-term use of RIPC in patients with AMI after PCI and non… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- RIPerC and RIPC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,146 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 1 Dec 2028
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute myocardial infarction were diagnosed in accordance with the criteria of the "Global Unified Definition of Fourth Myocardial Infarction"
Who cannot join
- The patients could not tolerate RIPC or RIPerC
- Aortic dissection, coronary artery aneurysm, coronary artery fistula and other systemic organic diseases
- The uncontrolled systolic blood pressure and diastolic blood pressure of severe hypertension were 180 mmHg and 120 mmHg respectively
- severe liver dysfunction (bilirubin > 20 mmol / L, prothrombin time > 2.0 ratio)
- Severe renal insufficiency (GFR < 30 ml / min / 1.73 m2);
- patients taking nicorandil and other drugs affecting microcirculation
- pregnant
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
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, 450000
GUO QUAN, 15670510031, xinyiguoquan@163.com
Muwei LI, 13838083966, lmw0207@163.com
About this study
At present, there are 290 million cardiovascular patients in China, including 11 million patients with coronary heart disease. Remote ischemic preconditioning(RIPC) may play an effective endogenous cardiac protection.This study will explore whether long-term use of RIPC in patients with AMI after PCI and non interventional therapy can reduce the incidence of major adverse cardiovascular cerebrovascular events(MACCE) and improve clinical outcomes and long-term prognosis.
Read the detailed description
A total of 2146 patients with AMI are expected included as the research objects and randomly divided into experimental group and control group with 1073 cases in each group. After admission, Patients in the experimental group received everyday RIPC of upper limbs to the end of follow-up.The control group is a blank control and undergoes conventional medical procedures. Routine blood indexes, ultrasound, electrocardiogram, were detected On the day of admission. 12 months post- discharge, the incidence of MACCE(include Cardiovascular death, non-fatal acute myocardial infarction, stent thrombosis, revascularization, stroke, admission due to heart failure and the above composite events were independent components) and Poce(All deaths, all strokes, all myocardial infarction, or all revascularization events)will recorded by telephone follow-up.
- Conditions
- Acute Myocardial Infarction
- Being tested
- RIPerC, RIPC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIPerCOther
Each 40 minutes treatment time, 10 minutes as a cycle (cuff inflated to 200 mmHg and maintained for 5 minutes, then deflated for 5 minutes to start the next cycle), a total of 4 cycles
RIPCOther
Each 40 minutes treatment time, 10 minutes as a cycle (cuff inflated to 200 mmHg and maintained for 5 minutes, then deflated for 5 minutes to start the next cycle), a total of 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group1(RIPerC+RIPC) | Experimental | Remote ischemic PERconditioning was initiated immediately after the diagnosis of acute myocardial infarction, and Remote ischemic PREconditioning was performed daily after discharge Receives: Other: RIPerC; Other: RIPC |
| Experimental Group2(RIPerC) | Experimental | Remote ischemic PERconditioning was initiated immediately after the diagnosis of acute myocardial infarction Receives: Other: RIPerC |
| Control group | No intervention | A group of patients who received conventional treatment without any additional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of MACCEs
MACCE(include Cardiovascular death, non-fatal acute myocardial infarction, revascularization, stroke, admission due to heart failure )
Measured: 12 months after discharge
Secondary outcomes (6)
Rate of Cardiovascular death events
Rate of Cardiovascular death events
Measured: 12 months after discharge
Rate of non-fatal acute myocardial infarction events
Rate of non-fatal acute myocardial infarction events
Measured: 12 months after discharge
Rate of revascularization events
Rate of revascularization events
Measured: 12 months after discharge
Rate of stroke events
Rate of stroke events
Measured: 12 months after discharge
Rate of admission due to heart failure events
Rate of admission due to heart failure events
Measured: 12 months after discharge
Rate of all all-cause death events
Rate of all all-cause death events
Measured: 12 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Jan 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients diagnosed with acute myocardial infarction on admission were immediately assigned to the experimental group and control group
- Masking
- None (open label)
- Enrolment
- 2,146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Institute of Cardiovascular Epidemiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muwei LI, Ph.D, Study chair, Fuwai Central China of Cardiovascular Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181356
- Sponsor's protocol ID
- HenanICE202105
- Acronym
- L-RICP-AMI
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Long-term Remote Ischemic Preconditioning on Clinical Outcome in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT07181356
- Acronym / sponsor ID
- L-RICP-AMI / HenanICE202105
- Conditions
- Acute Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,146 participants (estimated)
- Lead sponsor
- Henan Institute of Cardiovascular EpidemiologyUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 18 Sep 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.
At present, there are 290 million cardiovascular patients in China, including 11 million patients with coronary heart disease. Remote ischemic preconditioning(RIPC) may play an effective endogenous cardiac protection.This study will explore whether long-term use of RIPC in patients with AMI after PCI and non interventional therapy can reduce the incidence of major adverse cardiovascular cerebrovascular events(MACCE) and improve clinical outcomes and long-term prognosis.
Detailed description
A total of 2146 patients with AMI are expected included as the research objects and randomly divided into experimental group and control group with 1073 cases in each group. After admission, Patients in the experimental group received everyday RIPC of upper limbs to the end of follow-up.The control group is a blank control and undergoes conventional medical procedures. Routine blood indexes, ultrasound, electrocardiogram, were detected On the day of admission. 12 months post- discharge, the incidence of MACCE(include Cardiovascular death, non-fatal acute myocardial infarction, stent thrombosis, revascularization, stroke, admission due to heart failure and the above composite events were independent components) and Poce(All deaths, all strokes, all myocardial infarction, or all revascularization events)will recorded by telephone follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients diagnosed with acute myocardial infarction on admission were immediately assigned to the experimental group and control group
| Arm | Type | Receives |
|---|---|---|
| Experimental Group1(RIPerC+RIPC) | Experimental | Other: RIPerC, Other: RIPCRemote ischemic PERconditioning was initiated immediately after the diagnosis of acute myocardial infarction, and Remote ischemic PREconditioning was performed daily after discharge |
| Experimental Group2(RIPerC) | Experimental | Other: RIPerCRemote ischemic PERconditioning was initiated immediately after the diagnosis of acute myocardial infarction |
| Control group | No intervention | –A group of patients who received conventional treatment without any additional intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with acute myocardial infarction were diagnosed in accordance with the criteria of the "Global Unified Definition of Fourth Myocardial Infarction"
Key exclusion criteria (7 listed)
- The patients could not tolerate RIPC or RIPerC
- Aortic dissection, coronary artery aneurysm, coronary artery fistula and other systemic organic diseases
- The uncontrolled systolic blood pressure and diastolic blood pressure of severe hypertension were 180 mmHg and 120 mmHg respectively
- severe liver dysfunction (bilirubin > 20 mmol / L, prothrombin time > 2.0 ratio)
- Severe renal insufficiency (GFR < 30 ml / min / 1.73 m2);
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 |
|---|---|---|
| RIPerCEach 40 minutes treatment time, 10 minutes as a cycle (cuff inflated to 200 mmHg and maintained for 5 minutes, then deflated for 5 minutes to start the next cycle), a total of 4 cycles | Other | Experimental Group1(RIPerC+RIPC), Experimental Group2(RIPerC) |
| RIPCEach 40 minutes treatment time, 10 minutes as a cycle (cuff inflated to 200 mmHg and maintained for 5 minutes, then deflated for 5 minutes to start the next cycle), a total of 4 cycles | Other | Experimental Group1(RIPerC+RIPC) |
Primary outcome
Rate of MACCEs
Time frame: 12 months after discharge
MACCE(include Cardiovascular death, non-fatal acute myocardial infarction, revascularization, stroke, admission due to heart failure )
6 secondary outcomes
Rate of Cardiovascular death events
Time frame: 12 months after discharge
Rate of non-fatal acute myocardial infarction events
Time frame: 12 months after discharge
Rate of revascularization events
Time frame: 12 months after discharge
Rate of stroke events
Time frame: 12 months after discharge
Rate of admission due to heart failure events
Time frame: 12 months after discharge
Rate of all all-cause death events
Time frame: 12 months after discharge
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 18 Sep 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.
Muwei LI, Ph.D study chair
Fuwai Central China of Cardiovascular Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIPerC and RIPC in people with Acute Myocardial Infarction, run by Henan Institute of Cardiovascular Epidemiology 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 1 inclusion and 7 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 18 Sep 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?
Contact Muwei LI (13838083966, lmw0207@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of MACCEs (time frame: 12 months after discharge). 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 18 Sep 2025.