NCT03579914

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,206

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 9, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

November 4, 2021

Status Verified

October 1, 2021

Enrollment Period

2.8 years

First QC Date

May 17, 2018

Last Update Submit

October 27, 2021

Conditions

Keywords

Anterior Myocardial InfarctionIntravenous MetoprololRICMyocardial Protection

Outcome Measures

Primary Outcomes (1)

  • Myocardial infarct size

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

    60 hours

Secondary Outcomes (4)

  • Major adverse cardiac and cerebrovascular events (MACCE)

    1 year

  • Incidence of heart failure

    1 year

  • myocardial infarct size measured by MRI (optional)

    7 days after AMI

  • Safety endpoint: incidence of severe bradycardia or hypotension

    24 hours

Study Arms (4)

Placebo group

PLACEBO COMPARATOR

Patients receive intravenous placebo injection.

Drug: intravenous Placebo

Intravenous metoprolol group

EXPERIMENTAL

Patients receive intravenous metoprolol injection.

Drug: Metoprolol Injectable Product

RIC group

EXPERIMENTAL

Patients receive RIC treatment.

Device: Romote Ischemic Conditioning (RIC)

Intravenous metoprolol and RIC group

EXPERIMENTAL

Patients receive intravenous metoprolol injection and RIC treatment.

Combination Product: Metoprolol & RIC

Interventions

Patients receive intravenous Placebo (saline) injection

Placebo group

Patients receive intravenous Metoprolol injection

Intravenous metoprolol group

Patients receive RIC treatment

RIC group
Metoprolol & RICCOMBINATION_PRODUCT

Patients receive Metoprolol \& RIC treatment

Intravenous metoprolol and RIC group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Peking Univerisity People'Hospital

Beijing, Beijing Municipality, 100044, China

Location

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Guangdong general hospital

Guangzhou, Guangdong, China

Location

Second hospital of hebei medical university

Shijiazhuang, Hebei, China

Location

Daqing Oilfield General Hospital

Daqing, Heilongjiang, 163001, China

Location

The first affiliated hospital of Zhengzhou medical university

Zhengzhou, Henan, China

Location

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210009, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

The Second Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

the second affiliated hospital of Dalian medical university

Dalian, Liaoning, China

Location

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

Shenyang, Liaoning, China

Location

The first affiliated hospital of military medical university

Xi’an, Shanxi, China

Location

Third Military Medical University

Chongqing, Sichuan, China

Location

The General Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

Location

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Location

MeSH Terms

Conditions

Anterior Wall Myocardial InfarctionHeart Failure

Interventions

Metoprolol

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

May 17, 2018

First Posted

July 9, 2018

Study Start

November 28, 2017

Primary Completion

August 31, 2020

Study Completion

August 30, 2021

Last Updated

November 4, 2021

Record last verified: 2021-10

Locations