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Cardioprotective Effect of Dexmedetomidine in Patients With ST-segment Elevation Myocardial Infarction
Sponsor: Harbin Medical University
Summary
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%).
Official title: Cardioprotective Effect of Dexmedetomidine in Patients With ST-segment Elevation Myocardial Infarction: a Double-Blind, Multicenter, Randomized, Placebo-Controlled Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2021-05-27
Completion Date
2025-12
Last Updated
2024-10-15
Healthy Volunteers
No
Conditions
Interventions
Dexmedetomidine (DEX)
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)
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.
Locations (9)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Mudanjiang Cardiovascular Hospital
Mudanjiang, Heilongjiang, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China