Combined Metoprolol and Remote Ischemic Conditioning in Cardioprotection of Anterior ST-segment Elevation Myocardial Infarction (METRICATION)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,206
- Locations
- 16
- Primary Endpoint
- Myocardial infarct size
Study Overview
Brief Summary
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.
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 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Intravenous metoprolol group
Patients receive intravenous metoprolol injection.
Intervention: Metoprolol Injectable Product (Drug)
Placebo group
Patients receive intravenous placebo injection.
Intervention: intravenous Placebo (Drug)
RIC group
Patients receive RIC treatment.
Intervention: Romote Ischemic Conditioning (RIC) (Device)
Intravenous metoprolol and RIC group
Patients receive intravenous metoprolol injection and RIC treatment.
Intervention: Metoprolol & RIC (Combination Product)
Outcomes
Primary Outcomes
Myocardial infarct size
Time Frame: 60 hours
Estimating myocardial infarct size by area under CK, CK-MB curve
Secondary Outcomes
- Incidence of heart failure(1 year)
- Safety endpoint: incidence of severe bradycardia or hypotension(24 hours)
- Major adverse cardiac and cerebrovascular events (MACCE)(1 year)
- myocardial infarct size measured by MRI (optional)(7 days after AMI)
Investigators
Yu Bo
director
Harbin Medical University