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| Name | Class |
|---|---|
| Beijing Chao Yang Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator | Patients receive intravenous placebo injection. |
|
| Intravenous metoprolol group | Experimental | Patients receive intravenous metoprolol injection. |
|
| RIC group | Experimental | Patients receive RIC treatment. |
|
| Intravenous metoprolol and RIC group | Experimental | Patients receive intravenous metoprolol injection and RIC treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravenous Placebo | Drug | Patients receive intravenous Placebo (saline) injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial infarct size | Estimating myocardial infarct size by area under CK, CK-MB curve | 60 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac and cerebrovascular events (MACCE) | Composition of death, heart failure, reinfarction, revascularization, malignant ventricular arrhythmias, stroke) | 1 year |
| Incidence of heart failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Univerisity People'Hospital | Beijing | Beijing Municipality | 100044 | China | ||
| Beijing Chao-Yang Hospital, Capital Medical University |
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| Metoprolol Injectable Product |
| Drug |
Patients receive intravenous Metoprolol injection |
|
| Romote Ischemic Conditioning (RIC) | Device | Patients receive RIC treatment |
|
| Metoprolol & RIC | Combination Product | Patients receive Metoprolol & RIC treatment |
|
Incidence of heart failure
| 1 year |
| myocardial infarct size measured by MRI (optional) | myocardial infarct size measured by MRI (optional) | 7 days after AMI |
| Safety endpoint: incidence of severe bradycardia or hypotension | Severe bradycardia (heart rate <40bpm) or hypotension (systolic blood pressure <80mmHg) | 24 hours |
| Beijing |
| Beijing Municipality |
| China |
| Guangdong general hospital | Guangzhou | Guangdong | China |
| Second hospital of hebei medical university | Shijiazhuang | Hebei | China |
| Daqing Oilfield General Hospital | Daqing | Heilongjiang | 163001 | China |
| The first affiliated hospital of Zhengzhou medical university | Zhengzhou | Henan | China |
| Zhongda Hospital Southeast University | Nanjing | Jiangsu | 210009 | China |
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| The Second Hospital of Jilin University | Changchun | Jilin | 130000 | China |
| the second affiliated hospital of Dalian medical university | Dalian | Liaoning | China |
| Shenyang military district general hospital of the people's liberation army | Shenyang | Liaoning | China |
| The first affiliated hospital of military medical university | Xi’an | Shanxi | China |
| Third Military Medical University | Chongqing | Sichuan | China |
| The General Hospital of Tianjin Medical University | Tianjin | Tianjin Municipality | China |
| Tianjin Chest Hospital | Tianjin | Tianjin Municipality | China |
| The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | China |
| ID | Term |
|---|---|
| D056988 | Anterior Wall Myocardial Infarction |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D008790 | Metoprolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
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