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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

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.

Condition or disease Intervention/treatment Phase
Anterior Myocardial Infarction Heart Failure Drug: intravenous Placebo Drug: Metoprolol Injectable Product Device: Romote Ischemic Post-Conditioning (RIPC) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 28, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Placebo Comparator: Placebo group
Patients receive intravenous placebo injection.
Drug: intravenous Placebo
Patients receive intravenous Placebo injection

Experimental: Intravenous metoprolol group
Patients receive intravenous metoprolol injection.
Drug: Metoprolol Injectable Product
Patients receive intravenous Metoprolol injection

Experimental: RIPC group
Patients receive RIPC treatment.
Device: Romote Ischemic Post-Conditioning (RIPC)
Patients receive RIPC treatment

Experimental: Intravenous metoprolol and RIPC group
Patients receive intravenous metoprolol injection and RIPC treatment.
Drug: Metoprolol Injectable Product
Patients receive intravenous Metoprolol injection

Device: Romote Ischemic Post-Conditioning (RIPC)
Patients receive RIPC treatment




Primary Outcome Measures :
  1. Myocardial infarct size [ Time Frame: 60 hours ]
    Estimating myocardial infarct size by area under CK, CK-MB curve


Secondary Outcome Measures :
  1. Incidence of heart failure [ Time Frame: 1 year ]
    Incidence of heart failure

  2. myocardial infarct size measured by MRI [ Time Frame: 7 days after AMI ]
    myocardial infarct size measured by MRI

  3. Incidence of in-hospital heart failure [ Time Frame: up to 1 week ]
    Incidence of in-hospital heart failure

  4. MACCE [ Time Frame: 1 year ]
    MACCE

  5. Incidence of bradycardia and low pressue [ Time Frame: 24 hours ]
    Incidence of bradycardia and low pressue



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579914


Locations
Show Show 17 study locations
Sponsors and Collaborators
Harbin Medical University
Beijing Chao Yang Hospital

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Responsible Party: Yu Bo, director, Harbin Medical University
ClinicalTrials.gov Identifier: NCT03579914    
Other Study ID Numbers: 2016YFC1301102
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yu Bo, Harbin Medical University:
Anterior Myocardial Infarction
Intravenous Metoprolol
RIPC
Myocardial Protection
Additional relevant MeSH terms:
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Myocardial Infarction
Anterior Wall Myocardial Infarction
Infarction
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Metoprolol
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action