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Completed

NCT Number: NCT03579914

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

The main purpose of this study is to compare the myocardial protection effect of intravenous metoprolol combined with remote ischemic conditioning (RIC) 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Chao-Yang Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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About this study

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 conditioning (RIC) group and metoprolol & RIC 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, 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ages 18 to 80 years;
  • presenting within 12 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;
  • sign informed consent;

Exclusion criteria

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

Treatment and study plan

Intravenous placebo

Drug

Patients receive intravenous Placebo (saline) injection

Metoprolol Injectable Product

Drug

Patients receive intravenous Metoprolol injection

Romote Ischemic Conditioning (RIC)

Device

Patients receive RIC treatment

Metoprolol & RIC

Combination Product

Patients receive Metoprolol & RIC treatment

Primary outcomes

  1. Myocardial infarct size

    Time frame: 60 hours

    Estimating myocardial infarct size by area under CK, CK-MB curve

Secondary outcomes

  1. Major adverse cardiac and cerebrovascular events (MACCE)

    Time frame: 1 year

    Composition of death, heart failure, reinfarction, revascularization, malignant ventricular arrhythmias, stroke)

  2. Incidence of heart failure

    Time frame: 1 year

    Incidence of heart failure

  3. myocardial infarct size measured by MRI (optional)

    Time frame: 7 days after AMI

    myocardial infarct size measured by MRI (optional)

  4. Safety endpoint: incidence of severe bradycardia or hypotension

    Time frame: 24 hours

    Severe bradycardia (heart rate <40bpm) or hypotension (systolic blood pressure <80mmHg)

Sponsors and collaborators

Lead sponsor

Harbin Medical University

Other

Collaborators

  • Beijing Chao Yang Hospital

Registry information

Official study title

Combined Metoprolol and Remote Ischemic Conditioning in Cardioprotection of Anterior ST-segment Elevation Myocardial Infarction (METRICATION)

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Jul 9, 2018
Registry last updated
Nov 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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