Actively Recruiting
Cardioprotective Effect of Dexmedetomidine in Patients With ST-segment Elevation Myocardial Infarction
Led by Harbin Medical University · Updated on 2024-10-15
250
Participants Needed
9
Research Sites
235 weeks
Total Duration
On this page
Sponsors
H
Harbin Medical University
Lead Sponsor
Y
Yangtze River Pharmaceutical Group Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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%).
CONDITIONS
Official Title
Cardioprotective Effect of Dexmedetomidine in Patients With ST-segment Elevation Myocardial Infarction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years old
- Diagnosed with anterior STEMI within 6 hours of symptom onset, including ischemic chest discomfort and ECG showing ST elevation 60.2 mV in 2 or more contiguous precordial leads (including V2, V3, or V4)
- Signed informed consent form
You will not qualify if you...
- Ventricular fibrillation, cardiogenic shock, or Killip class III-IV
- Sinus bradycardia (heart rate below 60 beats per minute), PR interval over 240ms, or second to third degree atrioventricular block
- Continuous systolic blood pressure below 120 mmHg
- Severe breathing difficulties or arterial oxygen saturation below 92%
- Thrombolytic therapy before first medical contact in hospital
- Consciousness disorder or past cerebrovascular disease
- Previous myocardial infarction or PCI/CABG treatment
- Severe liver or kidney dysfunction
- Known allergy to dexmedetomidine
- Contraindications to cardiac magnetic resonance imaging (e.g., claustrophobia, pacemaker or ICD)
- Pregnant or lactating women
- Malignant tumor or expected survival less than 1 year
- Any condition making participation unsafe or unsuitable, including poor compliance
- Participation in other randomized controlled studies at the same time
AI-Screening
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Trial Site Locations
Total: 9 locations
1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230000
Actively Recruiting
2
The First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, China, 730000
Actively Recruiting
3
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150000
Actively Recruiting
4
Mudanjiang Cardiovascular Hospital
Mudanjiang, Heilongjiang, China, 1570011
Actively Recruiting
5
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
6
Wuhan Asia Heart Hospital
Wuhan, Hubei, China, 430022
Actively Recruiting
7
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China, 710068
Actively Recruiting
8
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China, 30001
Actively Recruiting
9
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China, 300192
Actively Recruiting
Research Team
J
Jiannan Dai, M.D., Ph.D
CONTACT
J
Jinfeng Tan, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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