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| Name | Class |
|---|---|
| Yangtze River Pharmaceutical Group Co., Ltd. | INDUSTRY |
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This is a double-blind, multicenter, randomized, placebo-controlled clinical trial. It is planned to enroll patients admitted with anterior ST-segment elevation myocardial infarction (STEMI) within 6h of symptom onset and undergo primary percutaneous coronary intervention (pPCI). Patients who meet the inclusion criteria and without exclusion criteria were randomized 1:1 into the dexmedetomidine (DEX) group or the placebo (saline) group after signing the informed consent. In the DEX group, intravenous injection of DEX was started immediately after enrollment, covering the entire PCI operation, and the administration was stopped at the end of the pPCI. The administration of saline was the same as those in the DEX group. The primary endpoint was the myocardial infarct size (MIS) as assessed by cardiac magnetic resonance imaging (CMR) at 5±2 days post-STEMI. Based on a superiority design and assuming an 20.0% relative infarct size reduction (from 26.0% to 20.8% with a SD of 13.0%), 250 patients are required to be enrolled, accounting for 20% drop-out (α= 0.05 and power= 80%).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine (DEX) group | Active Comparator | The patient began to inject DEX intravenously as soon as he enrolled. This study started with the maximum maintenance dose allowed by the label (0.7μg/kg/h). With reference to previous studies, we set 3 pump injection gradients within the range of 0.2-0.7μg/kg/h (0.2μg/kg/h, 0.45μg/kg/h, 0.7μg/kg/h), and based on the patient's heart rate , systolic blood pressure and RASS sedation score to adjust. |
|
| Placebo (Saline) group | Placebo Comparator | The patient began intravenous injection of normal saline immediately after enrollment. The administration method and dosage adjustment of normal saline are the same as DEX group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine (DEX) | Drug | The patient began to inject DEX intravenously as soon as he enrolled. This study started with the maximum maintenance dose allowed by the label (0.7μg/kg/h). With reference to previous studies, we set 3 pump injection gradients within the range of 0.2-0.7μg/kg/h (0.2μg/kg/h, 0.45μg/kg/h, 0.7μg/kg/h), and based on the patient's heart rate , systolic blood pressure and RASS sedation score to adjust. |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial infarction size (MIS) evaluated by CMR 5±2 days post-STEMI. | MIS was measured by CMR delayed gadolinium enhancement(expressed as %LV myocardial mass). | 5±2 days post-STEMI |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial salvage index (MSI) evaluated by CMR 5±2 days post-STEMI. | MSI defined as: (area at risk - myocardial infarct size) / area at risk × 100. | 5±2 days post-STEMI |
| Microvascular obstruction (MVO) evaluated by CMR 5±2 days post-STEMI. |
| Measure | Description | Time Frame |
|---|---|---|
| The major prespecified safety endpoint: a composite of cardiac death during the first 24 hours after admission. | A composite of cardiac death was defined death from cardiac causes | The first 24 hours after admission |
| The major prespecified safety endpoint: II-III degree atrioventricular block during the first 24 hours after admission. |
Inclusion Criteria: the enrolled subjects must meet all of the following criteria:
Exclusion Criteria: subjects who meet any one of the following criteria are excluded from the study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiannan Dai, M.D., Ph.D | Contact | +86 15124559838 | daijiannandr@163.com | |
| Jinfeng Tan, M.D. | Contact | +86 13633643383 | 418904005@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Bo Yu, M.D., FACC | The Second Affiliated Hospital of Harbin Medical University | Principal Investigator |
| Xi Su | Wuhan Asia Heart Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | 230000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29547992 | Background | Dai J, Xing L, Jia H, Zhu Y, Zhang S, Hu S, Lin L, Ma L, Liu H, Xu M, Ren X, Yu H, Li L, Zou Y, Zhang S, Mintz GS, Hou J, Yu B. In vivo predictors of plaque erosion in patients with ST-segment elevation myocardial infarction: a clinical, angiographical, and intravascular optical coherence tomography study. Eur Heart J. 2018 Jun 7;39(22):2077-2085. doi: 10.1093/eurheartj/ehy101. | |
| Background | 2. The World Bank. Toward a healthy and harmonious life in China: stemming the rising tide of non-communicable diseases. http://www.worldbank.org/content/dam/Worldbank/document/NCD_ report_en.pdf (accessed Nov 27, 2013). | ||
| 24969506 |
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|
| Placebo (Saline) | Drug | The patient began intravenous injection of normal saline immediately after enrollment. The administration method and dosage adjustment of normal saline are the same as DEX. |
|
MVO was evaluated qualitatively on delayed enhanced images; it was defined as hypodense regions within the hyperenhanced infracted area.
| 5±2 days post-STEMI |
| Left ventricular ejection fraction (LVEF) evaluated by CMR 5±2 days post-STEMI. | LVEF was defined as: (left ventricular end-diastolic volume - left ventricular end-systolic volume) / left ventricular end-diastolic volume × 100. | 5±2 days post-STEMI |
| The area under curve (AUC) for troponin I (cTnI) and creatine kinase-MB (CK-MB). | Myocardial ischemic injury markers refer to CK-MB and cTnI | First medical contact in hospital (before drug administration, baseline), and return to ward immediately, 6 Hours, 12 Hours, 24 Hours, 48 Hours after PCI procedure |
| The peak value for troponin I (cTnI) and creatine kinase-MB (CK-MB). | Myocardial ischemic injury markers refer to CK-MB and cTnI | First medical contact in hospital (before drug administration, baseline), and return to ward immediately, 6 Hours, 12 Hours, 24 Hours, 48 Hours after PCI procedure |
| LVEF evaluated by echocardiograhy at 30 days post-STEMI. | LVEF was defined as: (left ventricular end-diastolic volume - left ventricular end-systolic volume) / left ventricular end-diastolic volume × 100. | 30 days post-STEMI |
| Incidence of major adverse cardiovascular events (MACE): cardiac death, recurrent myocardial infarction, revascularization, rehospitalization due to heart failure. | Clinical follow-up is performed at 30 days, 3 months, 6 months, and 12 months. Follow-up at 30 days is in the outpatient clinic, other time frame follow-up is performed by phone call and clinical charts review. | 30 days and 12 months post-STEMI |
Atrioventricular block is defined as the abnormal conduction of electrical activation between the atria and ventricles during the conduction of electrical activation of the heart, which can lead to arrhythmia and prevent the heart from contracting and pumping blood normally. |
| The first 24 hours after admission |
| The major prespecified safety endpoint:severe sinus bradycardia during the first 24 hours after admission. | Severe sinus bradycardia was defined as heart rate (HR) sustained <50 beats/min | The first 24 hours after admission |
| The major prespecified safety endpoint:severe hypotension during the first 24 hours after admission. | severe hypotension was defined as continuous systolic blood pressure <80mmHg | The first 24 hours after admission |
| The major prespecified safety endpoint:malignant ventricular arrhythmia during the first 24 hours after admission. | malignant ventricular arrhythmia including ventricular tachycardia and ventricular fibrillation. | The first 24 hours after admission |
| Xiaohui Zheng |
| Henan Provincial People's Hospital |
| Principal Investigator |
| Kai Liu | Mudanjiang cardiovascular hospital | Principal Investigator |
| Jian An | Shanxi Cardiovascular Hospital | Principal Investigator |
| Xiling Shou | Shaanxi Provincial People's Hospital | Principal Investigator |
| Chengzhi Lu | Tianjin First Central Hospital | Principal Investigator |
| Xianhe Lin | The First Affiliated Hospital of Anhui Medical University | Principal Investigator |
| Zheng Zhang | LanZhou University | Principal Investigator |
| The First Affiliated Hospital of Lanzhou University | Recruiting | Lanzhou | Gansu | 730000 | China |
|
| The Second Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | 150000 | China |
|
| Mudanjiang Cardiovascular Hospital | Recruiting | Mudanjiang | Heilongjiang | 1570011 | China |
|
| Henan Provincial People's Hospital | Recruiting | Zhengzhou | Henan | 450000 | China |
|
| Wuhan Asia Heart Hospital | Recruiting | Wuhan | Hubei | 430022 | China |
|
| Shaanxi Provincial People's Hospital | Recruiting | Xi'an | Shaanxi | 710068 | China |
|
| Shanxi Cardiovascular Hospital | Recruiting | Taiyuan | Shanxi | 30001 | China |
|
| Tianjin First Central Hospital | Recruiting | Tianjin | Tianjin Municipality | 300192 | China |
|
| Background |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided