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

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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
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China, Beijing
Beijing An Zhen Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100029
Contact: Chunmei Wang    +8613521901670    wangchunmei0214@sina.com   
Peking Univerisity People'Hospital Recruiting
Beijing, Beijing, China, 100044
Contact: Weimin Wang    +8613901366076    weiminwang@vip.sina.com   
Beijing Chao-Yang Hospital, Capital Medical University Recruiting
Beijing, Beijing, China
Contact: Lefeng Wang    +8613601255020    wlf311@sohu.com   
Contact    +8613601255020      
China, Guangdong
Guangdong general hospital Recruiting
Guangzhou, Guangdong, China
Contact: Ning Tan    +8613903073651    tanning100@126.com   
China, Hebei
Second hospital of hebei medical university Recruiting
Shijiazhuang, Hebei, China
Contact: Xinshun Gu    +8613930139688    348220248@qq.com   
China, Heilongjiang
Daqing Oilfield General Hospital Recruiting
Daqing, Heilongjiang, China, 163001
Contact: Hui Li    +8613704673319    huilee_2006@163.com   
China, Henan
The first affiliated hospital of Zhengzhou medical university Recruiting
Zhengzhou, Henan, China
Contact: Ling Li    +8613607641631    liling63035@sina.com   
China, Jiangsu
Zhongda Hospital Southeast University Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Genshan Ma    +8613002580569    magenshan@hotmail.com   
China, Jiangxi
The Second Affiliated Hospital of Nanchang University Recruiting
Nanchang, Jiangxi, China, 330006
Contact: Yanqing Wu    +8613870885171    wuyanqing01@sina.com   
China, Jilin
The Second Hospital of Jilin University Recruiting
Changchun, Jilin, China, 130000
Contact: Bin Liu    +8613500810268    liubin3333@vip.sina.com   
China, Liaoning
the second affiliated hospital of Dalian medical university Recruiting
Dalian, Liaoning, China
Contact: Peng Qu    +8613304261697    qupeng777@aliyun.com   
Shenyang military district general hospital of the people's liberation army Recruiting
Shenyang, Liaoning, China
Contact: Bin Wang    +8615309882359    wangbindl@hotmail.com   
China, Shanxi
The first affiliated hospital of military medical university Recruiting
Xi'an, Shanxi, China
Contact: Zhijing Zhao    +8613772020951    zhaozhj@fmmu.edu.cn   
China, Sichuan
Third Military Medical University Recruiting
Chongqing, Sichuan, China
Contact: Jun Jin    +8613272605717    jjxqyy@163.com   
China, Tianjin
Tianjin Chest Hospital Recruiting
Tianjing, Tianjin, China
Contact: Chunjie Li    +8613820600988    ykwn@sina.com   
The General Hospital of Tianjin Medical University Recruiting
Tianjin, Tianjin, China
Contact: Wenjuan Zhang    +8613002226922    zwzzyy2013@163.com   
China, Xinjiang
The First Affiliated Hospital of Xinjiang Medical University Recruiting
Urumqi, Xinjiang, China
Contact: Yining Yang    +8613199860611    yangyn5126@163.com   
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     History of Changes
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