Effects of Long-term Remote Ischemic Preconditioning on Clinical Outcome in Patients With Acute Myocardial Infarction

NCT ID: NCT07181356

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2028-12-01

Brief Summary

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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

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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

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients diagnosed with acute myocardial infarction on admission were immediately assigned to the experimental group and control group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental Group1(RIPerC+RIPC)

Remote ischemic PERconditioning was initiated immediately after the diagnosis of acute myocardial infarction, and Remote ischemic PREconditioning was performed daily after discharge

Group Type EXPERIMENTAL

RIPerC

Intervention Type OTHER

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

RIPC

Intervention Type OTHER

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

Experimental Group2(RIPerC)

Remote ischemic PERconditioning was initiated immediately after the diagnosis of acute myocardial infarction

Group Type EXPERIMENTAL

RIPerC

Intervention Type OTHER

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

Control group

A group of patients who received conventional treatment without any additional intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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RIPerC

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

Intervention Type OTHER

RIPC

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with acute myocardial infarction were diagnosed in accordance with the criteria of the "Global Unified Definition of Fourth Myocardial Infarction"

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henan Institute of Cardiovascular Epidemiology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Muwei LI, Ph.D

Role: STUDY_CHAIR

Fuwai Central China of Cardiovascular Hospital

Locations

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Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Muwei LI

Role: CONTACT

13838083966

GUO QUAN

Role: CONTACT

15670510031

Facility Contacts

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GUO QUAN

Role: primary

15670510031

Muwei LI

Role: backup

13838083966

Other Identifiers

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HenanICE202105

Identifier Type: -

Identifier Source: org_study_id

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