Effect of Intravenous Metoprolol Combining RIPC on Myocardial Protection in STEMI Patients

Overview

This study is aim to discover the difference of protective effect on comparing Metoprolol administration before cardiac reperfusion combined with remote ischemic post-conditioning (RIPC) in patients with anterior STEMI in China. This study sought to find possible strategy on ameliorate the patients with anterior STEMI in China through the mechanisms on cardiac protection before cardiac reperfusion.

Full Title of Study: “Effect of Intravenous Metoprolol Combining RIPC on Myocardial Protection in Anterior ST-Segment Elevation Myocardial Infarction Patients Undergoing Primary PCI-A Prospective,Multicenter,Random Control,Cohort Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2020

Detailed Description

This study is a multicenter randomized controlled clinical trial, and planning to enroll 1200 patients with anterior STEMI. At the first medical contact´╝îpatients who meet the inclusion/exclusion criteria are divided into different groups before reperfusion. Patients randomize into placbo, Metoprolol, RIPC and Metorolol+RIPC groups. Subsequently, the investigator conduct diagnosis and treatment according to the patient's specific conditions. It is important to test early markers of myocardial damage at 12hrs, 24hrs, 36hrs, 48hrs and 60hrs(must item)during hospitalization. If the patient is treated with PCI, immediate post-operative myocardial injury markers are required(must item). Meanwhile, the investigator will collect information about disease diagnosis and treatment. All patients were followed for 1 year with an office visit at 1,3,6,9 and 12 months or a telephone call to evaluate the Health status and clinical events of patients.

Interventions

  • Drug: intravenous Placebo
    • Patients receive intravenous Placebo injection
  • Drug: Metoprolol Injectable Product
    • Patients receive intravenous Metoprolol injection
  • Device: Romote Ischemic Post-Conditioning (RIPC)
    • Patients receive RIPC treatment

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo group
    • Patients receive intravenous placebo injection.
  • Experimental: Intravenous metoprolol group
    • Patients receive intravenous metoprolol injection.
  • Experimental: RIPC group
    • Patients receive RIPC treatment.
  • Experimental: Intravenous metoprolol and RIPC group
    • Patients receive intravenous metoprolol injection and RIPC treatment.

Clinical Trial Outcome Measures

Primary Measures

  • Myocardial infarct size
    • Time Frame: 60 hours
    • Estimating myocardial infarct size by area under CK, CK-MB curve

Secondary Measures

  • Incidence of heart failure
    • Time Frame: 1 year
    • Incidence of heart failure
  • myocardial infarct size measured by MRI
    • Time Frame: 7 days after AMI
    • myocardial infarct size measured by MRI
  • Incidence of in-hospital heart failure
    • Time Frame: up to 1 week
    • Incidence of in-hospital heart failure
  • MACCE
    • Time Frame: 1 year
    • MACCE
  • Incidence of bradycardia and low pressue
    • Time Frame: 24 hours
    • Incidence of bradycardia and low pressue

Participating in This Clinical Trial

Inclusion Criteria

  • Patients ages 18 to 80 years, presenting within 6 h of symptoms onset, with anterior STEMI, de novo occlusion of LAD (TIMI [Thrombolysis In Myocardial Infarction] flow grade 0 to 1), and planned pPCI were eligible. Anterior STEMI was defined as the occurrence of >20 min of chest pain and ST-segment elevation (>2 mm) in at least 2 contiguous precordial leads.

Exclusion Criteria

  • previous anterior STEMI or <6 months nonanterior STEMI; Killip class IV; evidence of retrograde filling by collaterals at coronary angiography; severe multivessel coronary artery disease likely to require further interventions before follow-up ce-CMR (4 months); known severe abdominal aortic aneurysm (>50 mm); or severe peripheral artery disease (class III to IV)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Harbin Medical University
  • Collaborator
    • Beijing Chao Yang Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yu Bo, director – Harbin Medical University

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