Long-term Remote Ischemic Preconditioning Improve the Prognosis of Myocardial Infarction Patients With Emergency Reperfusion Therapy

Capital Medical University

Status: Unknown

Conditions: Myocardial Infarction, Acute

Treatments: Other: remote ischemic preconditioning （RIPC）

Study type: Interventional

Funder types: Other

Identifiers

NCT03018873

XuanwuH-RIPC1

Details and patient eligibility

About

Patients with acute myocardial infarction (AMI) are in critical condition. When primary percutaneous coronary intervention (PCI) was performing, no-reflow, reperfusion injury，heart failure, heart rupture, malignant arrhythmia maybe happen. It was reported remote ischemic preconditioning (RIPC) may play an effective endogenous cardiac protection. This study will investigate whether once RIPC before primary PCI or long-term RIPC can improve AMI patients short-term and long-term (1 year) prognosis. 400 STEMI patients undergoing primary PCI were randomly divided into 3 groups: long-term RIPC group (once preoperative RIPC and once RIPC/day after PCI), preoperative RIPC group (once preoperative RIPC), control group (without RIPC). Cardiac troponin (TNI), high-sensitivity C-reactive protein (hsCRP), adenosine, vascular endothelial growth factor (VEGF), hypoxia inducible factor-1 (HIF-1), echocardiography and magnetic resonance （MR）were detected 1 day, 1 month and 1 year after PCI. Patients will be followed up by telephone at the end of one year. The major adverse cardiovascular events (MACE) include cardiovascular death, spontaneous myocardial infarction, unplanned revascularization and stroke.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18-80 years;
• ST segment elevation myocardial infarction (STEMI);
• Plan to primary percutaneous coronary intervention.

Exclusion criteria

• Age more than 80;
• renal failure with creatinine >2 mg/dl;
• reject taking part in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 3 patient groups

long-term RIPC group

Experimental group

Description:

routine treatment + interventions interventions: once preoperative RIPC and once RIPC/day after PCI for one year. Once preoperative remote ischemic preconditioning （RIPC） : Three five-minute cycles of upper limb ischaemia and three five-minute pauses using a blood pressure cuff inflated to 200 mmHg before primary percutaneous coronary intervention(PCI). Once RIPC/day after PCI for one year:Three five-minute cycles of upper limb ischaemia and three five-minute pauses using a blood pressure cuff inflated to 200 mmHg.

Treatment:

Other: remote ischemic preconditioning （RIPC）

preoperative RIPC group

Active Comparator group

Description:

routine treatment + Once preoperative remote ischemic preconditioning （RIPC） : Three five-minute cycles of upper limb ischaemia and three five-minute pauses using a blood pressure cuff inflated to 200 mmHg before primary percutaneous coronary intervention.

Treatment:

Other: remote ischemic preconditioning （RIPC）

control group

No Intervention group

Description:

routine treatment, no RIPC