Effects of Long-term Remote Ischemic Preconditioning on Clinical Outcome in Patients With Acute Myocardial Infarction (L-RICP-AMI)

Henan Institute of Cardiovascular Epidemiology

Status: Enrolling

Conditions: Acute Myocardial Infarction

Treatments: Other: RIPC; Other: RIPerC

Study type: Interventional

Funder types: Other

Identifiers

NCT07181356

HenanICE202105

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,146 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,146 participants in 3 patient groups

Experimental Group1（RIPerC+RIPC）

Experimental group

Description:

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

Treatment:

Other: RIPerC

Other: RIPC

Experimental Group2（RIPerC）

Experimental group

Description:

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

Treatment:

Other: RIPerC

Control group

No Intervention group

Description:

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