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

Overview

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.

Interventions

• Other 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
• 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

Primary outcome measures

• Rate of MACCEs [Time frame: 12 months after discharge]

Secondary outcome measures (6)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Fuwai Central China Cardiovascular Hospital — Zhengzhou

Identifiers

NCT: NCT07181356 · HenanICE202105

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗