Cardioprotective Effect of Dexmedetomidine in Patients With ST-segment Elevation Myocardial Infarction: a Double-Blind, Multicenter, Randomized, Placebo-Controlled Clinical Trial

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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%).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Aged 18-75 years old (inclusive);

• Diagnosed with anterior STEMI within 6h of symptom onset: (1) ischemic chest discomfort; (2) electrocardiogram (ECG) with ST elevation ≥0.2 mV in 2 or more contiguous precordial leads (one of which should be V2, V3, or V4);

• Sign the informed consent form.

Locations
Other Locations
China
The Second Affiliated Hospital of Harbin Medical University
RECRUITING
Harbin
The First Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
The First Affiliated Hospital of Lanzhou University
RECRUITING
Lanzhou
Mudanjiang Cardiovascular Hospital
RECRUITING
Mudanjiang
Shanxi Cardiovascular Hospital
RECRUITING
Taiyuan
Tianjin First Central Hospital
RECRUITING
Tianjin
Wuhan Asia Heart Hospital
RECRUITING
Wuhan
Shaanxi Provincial People's Hospital
RECRUITING
Xi'an
Henan Provincial People's Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Jiannan Dai, M.D., Ph.D
daijiannandr@163.com
+86 15124559838
Backup
Jinfeng Tan, M.D.
418904005@qq.com
+86 13633643383
Time Frame
Start Date: 2021-05-27
Estimated Completion Date: 2025-12
Participants
Target number of participants: 250
Treatments
Active_comparator: Dexmedetomidine (DEX) group
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_comparator: Placebo (Saline) group
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.
Sponsors
Leads: Harbin Medical University
Collaborators: Yangtze River Pharmaceutical Group Co., Ltd.

This content was sourced from clinicaltrials.gov