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

NCT ID: NCT03018873

Last Updated: 2017-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31

Brief Summary

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.

Conditions

Myocardial Infarction, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

long-term RIPC group

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.

Group Type: EXPERIMENTAL

remote ischemic preconditioning （RIPC）

Intervention Type: OTHER

once RIPC: three five-minute cycles of upper limb ischaemia and three five-minute pauses using a blood pressure cuff inflated to 200 mmHg.

preoperative RIPC group

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.

Group Type: ACTIVE_COMPARATOR

remote ischemic preconditioning （RIPC）

Intervention Type: OTHER

once RIPC: three five-minute cycles of upper limb ischaemia and three five-minute pauses using a blood pressure cuff inflated to 200 mmHg.

control group

routine treatment, no RIPC

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

remote ischemic preconditioning （RIPC）

once RIPC: three five-minute cycles of upper limb ischaemia and three five-minute pauses using a blood pressure cuff inflated to 200 mmHg.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Liu zhi, doctor

Role: CONTACT

xwyy168@sina.com

13911517967

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Other Identifiers

XuanwuH-RIPC1

Identifier Type: -

Identifier Source: org_study_id