Effect of Intravenous Metoprolol Combining RIC on Myocardial Protection in STEMI Patients
- Conditions
- Anterior Myocardial InfarctionHeart Failure
- Interventions
- Drug: intravenous PlaceboDevice: Romote Ischemic Conditioning (RIC)Combination Product: Metoprolol & RIC
- Registration Number
- NCT03579914
- Lead Sponsor
- Harbin Medical University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1206
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Placebo group intravenous Placebo Patients receive intravenous placebo injection. Intravenous metoprolol group Metoprolol Injectable Product Patients receive intravenous metoprolol injection. RIC group Romote Ischemic Conditioning (RIC) Patients receive RIC treatment. Intravenous metoprolol and RIC group Metoprolol & RIC Patients receive intravenous metoprolol injection and RIC treatment.
- Primary Outcome Measures
Name Time Method Myocardial infarct size 60 hours Estimating myocardial infarct size by area under CK, CK-MB curve
- Secondary Outcome Measures
Name Time Method Incidence of heart failure 1 year Incidence of heart failure
Safety endpoint: incidence of severe bradycardia or hypotension 24 hours Severe bradycardia (heart rate \<40bpm) or hypotension (systolic blood pressure \<80mmHg)
Major adverse cardiac and cerebrovascular events (MACCE) 1 year Composition of death, heart failure, reinfarction, revascularization, malignant ventricular arrhythmias, stroke)
myocardial infarct size measured by MRI (optional) 7 days after AMI myocardial infarct size measured by MRI (optional)
Trial Locations
- Locations (16)
Shenyang military district general hospital of the people's liberation army
🇨🇳Shenyang, Liaoning, China
Second hospital of hebei medical university
🇨🇳Shijiazhuang, Hebei, China
Daqing Oilfield General Hospital
🇨🇳Daqing, Heilongjiang, China
The Second Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Peking Univerisity People'Hospital
🇨🇳Beijing, Beijing, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China
The first affiliated hospital of Zhengzhou medical university
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Third Military Medical University
🇨🇳Chongqing, Sichuan, China
The General Hospital of Tianjin Medical University
🇨🇳Tianjin, Tianjin, China
Guangdong general hospital
🇨🇳Guangzhou, Guangdong, China
Beijing Chao-Yang Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
the second affiliated hospital of Dalian medical university
🇨🇳Dalian, Liaoning, China
The first affiliated hospital of military medical university
🇨🇳Xi'an, Shanxi, China
Tianjin Chest Hospital
🇨🇳Tianjing, Tianjin, China