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

NCT ID: NCT03579914

Last Updated: 2021-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-28

Study Completion Date

2021-08-30

Brief Summary

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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

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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.

Conditions

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Anterior Myocardial Infarction Heart Failure

Keywords

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Anterior Myocardial Infarction Intravenous Metoprolol RIC Myocardial Protection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Placebo group

Patients receive intravenous placebo injection.

Group Type PLACEBO_COMPARATOR

intravenous Placebo

Intervention Type DRUG

Patients receive intravenous Placebo (saline) injection

Intravenous metoprolol group

Patients receive intravenous metoprolol injection.

Group Type EXPERIMENTAL

Metoprolol Injectable Product

Intervention Type DRUG

Patients receive intravenous Metoprolol injection

RIC group

Patients receive RIC treatment.

Group Type EXPERIMENTAL

Romote Ischemic Conditioning (RIC)

Intervention Type DEVICE

Patients receive RIC treatment

Intravenous metoprolol and RIC group

Patients receive intravenous metoprolol injection and RIC treatment.

Group Type EXPERIMENTAL

Metoprolol & RIC

Intervention Type COMBINATION_PRODUCT

Patients receive Metoprolol \& RIC treatment

Interventions

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intravenous Placebo

Patients receive intravenous Placebo (saline) injection

Intervention Type DRUG

Metoprolol Injectable Product

Patients receive intravenous Metoprolol injection

Intervention Type DRUG

Romote Ischemic Conditioning (RIC)

Patients receive RIC treatment

Intervention Type DEVICE

Metoprolol & RIC

Patients receive Metoprolol \& RIC treatment

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Chao Yang Hospital

OTHER

Sponsor Role collaborator

Harbin Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yu Bo

director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking Univerisity People'Hospital

Beijing, Beijing Municipality, China

Site Status

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Guangdong general hospital

Guangzhou, Guangdong, China

Site Status

Second hospital of hebei medical university

Shijiazhuang, Hebei, China

Site Status

Daqing Oilfield General Hospital

Daqing, Heilongjiang, China

Site Status

The first affiliated hospital of Zhengzhou medical university

Zhengzhou, Henan, China

Site Status

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

Site Status

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status

The Second Hospital of Jilin University

Changchun, Jilin, China

Site Status

the second affiliated hospital of Dalian medical university

Dalian, Liaoning, China

Site Status

Shenyang military district general hospital of the people's liberation army

Shenyang, Liaoning, China

Site Status

The first affiliated hospital of military medical university

Xi’an, Shanxi, China

Site Status

Third Military Medical University

Chongqing, Sichuan, China

Site Status

The General Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

Site Status

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, China

Site Status

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status

Countries

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China

Other Identifiers

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2016YFC1301102

Identifier Type: -

Identifier Source: org_study_id