Clinical trial NCT03579914: Effect of Intravenous Metoprolol Combining RIC on Myocardial Protection in STEMI Patients
Official title: Combined Metoprolol and Remote Ischemic Conditioning in Cardioprotection of Anterior ST-segment Elevation Myocardial Infarction (METRICATION)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Myocardial Infarction
Heart Failure
Keywords: Anterior Myocardial Infarction
Intravenous Metoprolol
RIC
Myocardial Protection
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
Collaborators: name: Beijing Chao Yang Hospital
First posted: 2018-07-09
Enrollment: 1206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Myocardial infarct size
timeFrame: 60 hours
Secondary outcomes:
measure: Major adverse cardiac and cerebrovascular events (MACCE)
timeFrame: 1 year
measure: Incidence of heart failure
timeFrame: 1 year
measure: myocardial infarct size measured by MRI (optional)
timeFrame: 7 days after AMI
measure: Safety endpoint: incidence of severe bradycardia or hypotension
timeFrame: 24 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Univerisity People'Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital, Capital Medical University
state: Beijing
city: Guangzhou
country: China
facility: Guangdong general hospital
state: Guangdong
city: Shijiazhuang
country: China
facility: Second hospital of hebei medical university
state: Hebei
city: Daqing
country: China
facility: Daqing Oilfield General Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: The first affiliated hospital of Zhengzhou medical university
state: Henan
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: the second affiliated hospital of Dalian medical university
state: Liaoning
city: Shenyang
country: China
facility: Shenyang military district general hospital of the people's liberation army
state: Liaoning
city: Xi'an
country: China
facility: The first affiliated hospital of military medical university
state: Shanxi
city: Chongqing
country: China
facility: Third Military Medical University
state: Sichuan
city: Tianjing
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Tianjin
country: China
facility: The General Hospital of Tianjin Medical University
state: Tianjin
city: Urumqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
Study officials:
References: