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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03579914
Recruitment Status : Recruiting
First Posted : July 9, 2018
Last Update Posted : July 9, 2018
Sponsor:
Collaborator:
Beijing Chao Yang Hospital
Information provided by (Responsible Party):
Yu Bo, Harbin Medical University

Tracking Information
First Submitted Date  ICMJE May 17, 2018
First Posted Date  ICMJE July 9, 2018
Last Update Posted Date July 9, 2018
Actual Study Start Date  ICMJE November 28, 2017
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2018)
Myocardial infarct size [ Time Frame: 60 hours ]
Estimating myocardial infarct size by area under CK, CK-MB curve
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2018)
  • Incidence of heart failure [ Time Frame: 1 year ]
    Incidence of heart failure
  • myocardial infarct size measured by MRI [ Time Frame: 7 days after AMI ]
    myocardial infarct size measured by MRI
  • Incidence of in-hospital heart failure [ Time Frame: up to 1 week ]
    Incidence of in-hospital heart failure
  • MACCE [ Time Frame: 1 year ]
    MACCE
  • Incidence of bradycardia and low pressue [ Time Frame: 24 hours ]
    Incidence of bradycardia and low pressue
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Intravenous Metoprolol Combining RIPC on Myocardial Protection in STEMI Patients
Official Title  ICMJE Effect of Intravenous Metoprolol Combining RIPC on Myocardial Protection in Anterior ST-Segment Elevation Myocardial Infarction Patients Undergoing Primary PCI-A Prospective,Multicenter,Random Control,Cohort Study
Brief Summary This study is aim to discover the difference of protective effect on comparing Metoprolol administration before cardiac reperfusion combined with remote ischemic post-conditioning (RIPC) in patients with anterior STEMI in China. This study sought to find possible strategy on ameliorate the patients with anterior STEMI in China through the mechanisms on cardiac protection before cardiac reperfusion.
Detailed Description This study is a multicenter randomized controlled clinical trial, and planning to enroll 1200 patients with anterior STEMI. At the first medical contact,patients who meet the inclusion/exclusion criteria are divided into different groups before reperfusion. Patients randomize into placbo, Metoprolol, RIPC and Metorolol+RIPC groups. Subsequently, the investigator conduct diagnosis and treatment according to the patient's specific conditions. It is important to test early markers of myocardial damage at 12hrs, 24hrs, 36hrs, 48hrs and 60hrs(must item)during hospitalization. If the patient is treated with PCI, immediate post-operative myocardial injury markers are required(must item). Meanwhile, the investigator will collect information about disease diagnosis and treatment. All patients were followed for 1 year with an office visit at 1,3,6,9 and 12 months or a telephone call to evaluate the Health status and clinical events of patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anterior Myocardial Infarction
  • Heart Failure
Intervention  ICMJE
  • Drug: intravenous Placebo
    Patients receive intravenous Placebo injection
  • Drug: Metoprolol Injectable Product
    Patients receive intravenous Metoprolol injection
  • Device: Romote Ischemic Post-Conditioning (RIPC)
    Patients receive RIPC treatment
Study Arms  ICMJE
  • Placebo Comparator: Placebo group
    Patients receive intravenous placebo injection.
    Intervention: Drug: intravenous Placebo
  • Experimental: Intravenous metoprolol group
    Patients receive intravenous metoprolol injection.
    Intervention: Drug: Metoprolol Injectable Product
  • Experimental: RIPC group
    Patients receive RIPC treatment.
    Intervention: Device: Romote Ischemic Post-Conditioning (RIPC)
  • Experimental: Intravenous metoprolol and RIPC group
    Patients receive intravenous metoprolol injection and RIPC treatment.
    Interventions:
    • Drug: Metoprolol Injectable Product
    • Device: Romote Ischemic Post-Conditioning (RIPC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 5, 2018)
1200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients ages 18 to 80 years, presenting within 6 h of symptoms onset, with anterior STEMI, de novo occlusion of LAD (TIMI [Thrombolysis In Myocardial Infarction] flow grade 0 to 1), and planned pPCI were eligible. 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.

Exclusion Criteria:

- previous anterior STEMI or <6 months nonanterior STEMI; Killip class IV; evidence of retrograde filling by collaterals at coronary angiography; severe multivessel coronary artery disease likely to require further interventions before follow-up ce-CMR (4 months); known severe abdominal aortic aneurysm (>50 mm); or severe peripheral artery disease (class III to IV)

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03579914
Other Study ID Numbers  ICMJE 2016YFC1301102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yu Bo, Harbin Medical University
Study Sponsor  ICMJE Harbin Medical University
Collaborators  ICMJE Beijing Chao Yang Hospital
Investigators  ICMJE Not Provided
PRS Account Harbin Medical University
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP