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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03579914
• Other study ID #: 2016YFC1301102
• Status: Completed
• Phase: N/A
• Start date: November 28, 2017
• Est. completion date: August 30, 2021

Study information

• Verified date: October 2021
• Source: Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1206
• Est. completion date: August 30, 2021
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Myocardial Infarction
• Anterior Wall Myocardial Infarction
• Heart Failure
• Infarction
• Myocardial Infarction

Intervention

Drug:
• intravenous Placebo
Patients receive intravenous Placebo (saline) injection
• Metoprolol Injectable Product
Patients receive intravenous Metoprolol injection

Device:
• Romote Ischemic Conditioning (RIC)
Patients receive RIC treatment

Combination Product:
• Metoprolol & RIC
Patients receive Metoprolol & RIC treatment

Locations

Country	Name	City	State
China	Beijing Chao-Yang Hospital, Capital Medical University	Beijing	Beijing
China	Peking Univerisity People'Hospital	Beijing	Beijing
China	The Second Hospital of Jilin University	Changchun	Jilin
China	Third Military Medical University	Chongqing	Sichuan
China	the second affiliated hospital of Dalian medical university	Dalian	Liaoning
China	Daqing Oilfield General Hospital	Daqing	Heilongjiang
China	Guangdong general hospital	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu
China	Shenyang military district general hospital of the people's liberation army	Shenyang	Liaoning
China	Second hospital of hebei medical university	Shijiazhuang	Hebei
China	The General Hospital of Tianjin Medical University	Tianjin	Tianjin
China	Tianjin Chest Hospital	Tianjing	Tianjin
China	The First Affiliated Hospital of Xinjiang Medical University	Urumqi	Xinjiang
China	The first affiliated hospital of military medical university	Xi'an	Shanxi
China	The first affiliated hospital of Zhengzhou medical university	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Harbin Medical University	Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial infarct size	Estimating myocardial infarct size by area under CK, CK-MB curve	60 hours
Secondary	Major adverse cardiac and cerebrovascular events (MACCE)	Composition of death, heart failure, reinfarction, revascularization, malignant ventricular arrhythmias, stroke)	1 year
Secondary	Incidence of heart failure	Incidence of heart failure	1 year
Secondary	myocardial infarct size measured by MRI (optional)	myocardial infarct size measured by MRI (optional)	7 days after AMI
Secondary	Safety endpoint: incidence of severe bradycardia or hypotension	Severe bradycardia (heart rate <40bpm) or hypotension (systolic blood pressure <80mmHg)	24 hours