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

Overview

The main purpose of this study is to compare the myocardial protection effect of intravenous metoprolol combined with remote ischemic post-conditioning (RIPC) and single treatment before reperfusion in Chinese patients with anterior STEMI. This study sought to find possible strategies to further improve myocardial protection in Chinese patients with anterior STEMI.

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: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2020

Detailed Description

This study is a prospective, multi-center, randomized controlled study. It is planned to enroll 1200 patients with anterior STEMI. Immediately after the first medical contact, the patients who were determined by the investigator to meet the inclusion/exclusion criteria were randomized through the interactive web response system (IWRS) and received different pre-reperfusion treatments. The four groups were placebo group, metoprolol group, remote ischemic post-conditioning (RIPC) group and metoprolol & RIPC group. Subsequently, the investigator conduct diagnosis and treatment according to the patient's specific conditions and check the serum level of myocardial damage markers (i.e. CK and CK-MB) at the time of admission for 12, 24, 36, 48, 60 hours, respectively. If the patient undergoes PCI treatment, additional detection of myocardial damage markers immediately after PCI is also required. All patients were followed for 1 year with an office visit or a telephone call at 1, 3, 6, 9 and 12 months to evaluate the health status and adverse clinical events of patients.

Interventions

  • Drug: intravenous Placebo
    • Patients receive intravenous Placebo (saline) injection
  • Drug: Metoprolol Injectable Product
    • Patients receive intravenous Metoprolol injection
  • Device: Romote Ischemic Post-Conditioning (RIPC)
    • Patients receive RIPC treatment
  • Combination Product: Metoprolol & RIPC
    • Patients receive Metoprolol & 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 (optional)
    • Time Frame: 7 days after AMI
    • myocardial infarct size measured by MRI (optional)
  • Incidence of in-hospital heart failure
    • Time Frame: up to 1 week
    • Incidence of in-hospital heart failure
  • incidence of re-admission due to heart failure
    • Time Frame: 1 year
    • incidence of re-admission due to heart failure
  • Major adverse cardiac and cerebrovascular events (MACCE)
    • Time Frame: 1 year
    • Composition of death, reinfarction, revascularization, malignant ventricular arrhythmias, stroke, re-admission due to heart failure)
  • Safety endpoint: incidence of severe bradycardia or hypotension
    • Time Frame: 24 hours
    • Severe bradycardia (heart rate <40bpm) or hypotension (systolic blood pressure <80mmHg)

Participating in This Clinical Trial

Inclusion Criteria

1. ages 18 to 80 years; 2. presenting within 6 h of symptoms onset, with anterior STEMI and planned for pPCI; 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; 3. sign informed consent; Exclusion Criteria:

1. systolic blood pressure < 110mmHg; 2. cardiogenic shock or with heart failure symptoms, Killip III~IV; 3. allergic history of metoprolol; 4. history of asthma or the need for bronchodilators; 5. PR interval > 240ms, II~III atrioventricular blockļ¼› 6. heart rate < 60 beats/min; 7. unable to consent; 8. pregnancy and lactation women; 9. life expectancy for diseases (i.e. cancer) < 1 year.

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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.