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

Harbin Medical University1,206 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,206

Conditions

Anterior Myocardial Infarction Heart Failure

Interventions

intravenous PlaceboDRUG

Patients receive intravenous Placebo (saline) injection

Metoprolol Injectable ProductDRUG

Patients receive intravenous Metoprolol injection

Romote Ischemic Conditioning (RIC)DEVICE

Patients receive RIC treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. ages 18 to 80 years; 2. 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; 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 block； 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.

Locations (16)

Peking Univerisity People'Hospital

Beijing, Beijing Municipality, China

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Myocardial infarct size

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

Time frame: 60 hours

Secondary Outcomes

Major adverse cardiac and cerebrovascular events (MACCE)

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

Time frame: 1 year

Incidence of heart failure

Time frame: 1 year

myocardial infarct size measured by MRI (optional)

Time frame: 7 days after AMI

Safety endpoint: incidence of severe bradycardia or hypotension

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

Time frame: 24 hours

Data from ClinicalTrials.gov

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