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

Primary Purpose

Anterior Myocardial Infarction, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
intravenous Placebo
Metoprolol Injectable Product
Romote Ischemic Conditioning (RIC)
Metoprolol & RIC
Sponsored by
Harbin Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Myocardial Infarction focused on measuring Anterior Myocardial Infarction, Intravenous Metoprolol, RIC, Myocardial Protection

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Peking Univerisity People'Hospital
  • Beijing Chao-Yang Hospital, Capital Medical University
  • Guangdong general hospital
  • Second hospital of hebei medical university
  • Daqing Oilfield General Hospital
  • The first affiliated hospital of Zhengzhou medical university
  • Zhongda Hospital Southeast University
  • The Second Affiliated Hospital of Nanchang University
  • The Second Hospital of Jilin University
  • the second affiliated hospital of Dalian medical university
  • Shenyang military district general hospital of the people's liberation army
  • The first affiliated hospital of military medical university
  • Third Military Medical University
  • Tianjin Chest Hospital
  • The General Hospital of Tianjin Medical University
  • The First Affiliated Hospital of Xinjiang Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo group

Intravenous metoprolol group

RIC group

Intravenous metoprolol and RIC group

Arm Description

Patients receive intravenous placebo injection.

Patients receive intravenous metoprolol injection.

Patients receive RIC treatment.

Patients receive intravenous metoprolol injection and RIC treatment.

Outcomes

Primary Outcome Measures

Myocardial infarct size
Estimating myocardial infarct size by area under CK, CK-MB curve

Secondary Outcome Measures

Major adverse cardiac and cerebrovascular events (MACCE)
Composition of death, heart failure, reinfarction, revascularization, malignant ventricular arrhythmias, stroke)
Incidence of heart failure
Incidence of heart failure
myocardial infarct size measured by MRI (optional)
myocardial infarct size measured by MRI (optional)
Safety endpoint: incidence of severe bradycardia or hypotension
Severe bradycardia (heart rate <40bpm) or hypotension (systolic blood pressure <80mmHg)

Full Information

First Posted
May 17, 2018
Last Updated
October 27, 2021
Sponsor
Harbin Medical University
Collaborators
Beijing Chao Yang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03579914
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 28, 2017 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harbin Medical University
Collaborators
Beijing Chao Yang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Myocardial Infarction, Heart Failure
Keywords
Anterior Myocardial Infarction, Intravenous Metoprolol, RIC, Myocardial Protection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Patients receive intravenous placebo injection.
Arm Title
Intravenous metoprolol group
Arm Type
Experimental
Arm Description
Patients receive intravenous metoprolol injection.
Arm Title
RIC group
Arm Type
Experimental
Arm Description
Patients receive RIC treatment.
Arm Title
Intravenous metoprolol and RIC group
Arm Type
Experimental
Arm Description
Patients receive intravenous metoprolol injection and RIC treatment.
Intervention Type
Drug
Intervention Name(s)
intravenous Placebo
Intervention Description
Patients receive intravenous Placebo (saline) injection
Intervention Type
Drug
Intervention Name(s)
Metoprolol Injectable Product
Intervention Description
Patients receive intravenous Metoprolol injection
Intervention Type
Device
Intervention Name(s)
Romote Ischemic Conditioning (RIC)
Intervention Description
Patients receive RIC treatment
Intervention Type
Combination Product
Intervention Name(s)
Metoprolol & RIC
Intervention Description
Patients receive Metoprolol & RIC treatment
Primary Outcome Measure Information:
Title
Myocardial infarct size
Description
Estimating myocardial infarct size by area under CK, CK-MB curve
Time Frame
60 hours
Secondary Outcome Measure Information:
Title
Major adverse cardiac and cerebrovascular events (MACCE)
Description
Composition of death, heart failure, reinfarction, revascularization, malignant ventricular arrhythmias, stroke)
Time Frame
1 year
Title
Incidence of heart failure
Description
Incidence of heart failure
Time Frame
1 year
Title
myocardial infarct size measured by MRI (optional)
Description
myocardial infarct size measured by MRI (optional)
Time Frame
7 days after AMI
Title
Safety endpoint: incidence of severe bradycardia or hypotension
Description
Severe bradycardia (heart rate <40bpm) or hypotension (systolic blood pressure <80mmHg)
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Peking Univerisity People'Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Beijing Chao-Yang Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Guangdong general hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Second hospital of hebei medical university
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
Daqing Oilfield General Hospital
City
Daqing
State/Province
Heilongjiang
ZIP/Postal Code
163001
Country
China
Facility Name
The first affiliated hospital of Zhengzhou medical university
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Zhongda Hospital Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
The Second Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Facility Name
the second affiliated hospital of Dalian medical university
City
Dalian
State/Province
Liaoning
Country
China
Facility Name
Shenyang military district general hospital of the people's liberation army
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
The first affiliated hospital of military medical university
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
Third Military Medical University
City
Chongqing
State/Province
Sichuan
Country
China
Facility Name
Tianjin Chest Hospital
City
Tianjing
State/Province
Tianjin
Country
China
Facility Name
The General Hospital of Tianjin Medical University
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
The First Affiliated Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
Country
China

12. IPD Sharing Statement

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

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