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%).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
250
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.
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.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGThe First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, China
RECRUITINGThe Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
RECRUITINGMudanjiang Cardiovascular Hospital
Mudanjiang, Heilongjiang, China
RECRUITINGHenan Provincial People's Hospital
Zhengzhou, Henan, China
RECRUITINGWuhan Asia Heart Hospital
Wuhan, Hubei, China
RECRUITINGShaanxi Provincial People's Hospital
Xi'an, Shaanxi, China
RECRUITINGShanxi Cardiovascular Hospital
Taiyuan, Shanxi, China
RECRUITINGTianjin First Central Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGMyocardial infarction size (MIS) evaluated by CMR 5±2 days post-STEMI.
MIS was measured by CMR delayed gadolinium enhancement（expressed as %LV myocardial mass).
Time frame: 5±2 days post-STEMI
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.
Time frame: 5±2 days post-STEMI
Microvascular obstruction (MVO) evaluated by CMR 5±2 days post-STEMI.
MVO was evaluated qualitatively on delayed enhanced images; it was defined as hypodense regions within the hyperenhanced infracted area.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 30 days and 12 months post-STEMI
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