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

NCT07181356 | Recruiting

• 1 other identifier: HenanICE202105
• Study Type: interventional
• Target: 2,146
• Locations: 1 country
• Sites: 1

Brief 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 interventional therapy can reduce the incidence of major adverse cardiovascular cerebrovascular events(MACCE) and improve clinical outcomes and long-term prognosis.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Rate of MACCEs

  MACCE(include Cardiovascular death, non-fatal acute myocardial infarction, revascularization, stroke, admission due to heart failure )

  12 months after discharge

Secondary Outcomes (6)

• Rate of Cardiovascular death events

  12 months after discharge

• Rate of non-fatal acute myocardial infarction events

  12 months after discharge

• Rate of revascularization events

  12 months after discharge

• Rate of stroke events

  12 months after discharge

• Rate of admission due to heart failure events

  12 months after discharge

Study Arms (3)

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

Other: RIPerC; Other: RIPC

Experimental Group2（RIPerC）

EXPERIMENTAL

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

Other: RIPerC

Control group

NO INTERVENTION

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

Interventions

RIPerC 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 Group1（RIPerC+RIPC）; Experimental Group2（RIPerC）

RIPC 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 Group1（RIPerC+RIPC）

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan Institute of Cardiovascular Epidemiology: lead

Study Sites (1)

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

Study Officials

• Muwei LI, Ph.D

  Fuwai Central China of Cardiovascular Hospital

  STUDY CHAIR

Central Study Contacts

Muwei LI

CONTACT

13838083966; lmw0207@163.com

GUO QUAN

CONTACT

15670510031; xinyiguoquan@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients diagnosed with acute myocardial infarction on admission were immediately assigned to the experimental group and control group

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 18, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

CN (1)