Study of Dexmedetomidine to Protect the Heart in Patients Aged 18 to 75 With Anterior ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Led by Harbin Medical University · Updated on 2024-10-15
250
Participants Needed
9
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of dexmedetomidine DEX on heart damage size in patients who have experienced an anterior ST-segment elevation myocardial infarction STEMI and are undergoing primary percutaneous coronary intervention pPCI within 6 hours of symptom onset. This double-blind, randomized, placebo-controlled trial aims to determine if DEX can reduce myocardial infarct size compared to a placebo. The trial plans to enroll 250 patients to achieve reliable results.
Participants are randomly assigned to either the DEX group or the placebo group in a 11 ratio. Those in the DEX group receive an intravenous infusion starting immediately upon enrollment, with doses adjusted between 0.2 to 0.7 gkgh based on heart rate, blood pressure, and sedation scores, continuing throughout the PCI procedure. The placebo group receives saline infusions following the same schedule and dose adjustments. This treatment phase occurs during the PCI operation.
During the study, patients undergo cardiac magnetic resonance imaging CMR about 5 days after STEMI to measure myocardial infarct size and other heart function indicators. Additional evaluations include blood tests for heart damage markers at multiple time points after PCI and echocardiography at 30 days. Researchers track major adverse cardiovascular events up to 12 months post-STEMI. Total participation includes initial treatment and follow-up assessments over one year.
CONDITIONS
Brief Title
Cardioprotective Effect of Dexmedetomidine in Patients With ST-segment Elevation Myocardial Infarction
Research Team
J
Jiannan Dai, M.D., Ph.D
J
Jinfeng Tan, M.D.
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Diagnosed with anterior STEMI within 6 hours of symptom onset, confirmed by ischemic chest discomfort and specific ECG changes
Signed informed consent form
You will not qualify if you...
Ventricular fibrillation, cardiogenic shock, or Killip class III-IV heart failure
Sinus bradycardia with heart rate under 60 beats per minute, prolonged PR interval over 240ms, or second to third degree atrioventricular block
Continuous systolic blood pressure below 120 mmHg
Severe breathing difficulties or arterial blood oxygen saturation below 92%
Thrombolytic therapy before first medical contact
Consciousness disorder or past stroke
Previous myocardial infarction or PCI/CABG treatment
Known severe liver or kidney dysfunction
Allergy to dexmedetomidine
Contraindications to cardiac MRI such as claustrophobia or implanted pacemaker/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 trials at the same time
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 48 hours post-PCI procedure
Participants receive intravenous infusion of dexmedetomidine or placebo immediately after enrollment. Dosage is adjusted based on heart rate, blood pressure, and sedation score.
Multiple assessments including before drug administration and at 6, 12, 24, and 48 hours after PCI procedure
Follow-up
Duration - Up to 12 months post-STEMI
Participants undergo cardiac magnetic resonance imaging (CMR) and echocardiography to evaluate heart function and myocardial injury, and are monitored for major adverse cardiovascular events.
Visits at approximately 5 days, 30 days, and 12 months post-STEMI
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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Published Research Related To This Trial
In vivo predictors of plaque erosion in patients with ST-segment elevation myocardial infarction: a clinical, angiographical, and intravascular optical coherence tomography study.
Effect of early metoprolol on infarct size in ST-segment-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention: the Effect of Metoprolol in Cardioprotection During an Acute Myocardial Infarction (METOCARD-CNIC) trial.
Borja Ibanez, Carlos Macaya, Vicente Sánchez-Brunete...
2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC).
Effects of Dexmedetomidine Postconditioning on Myocardial Ischemia/Reperfusion Injury in Diabetic Rats: Role of the PI3K/Akt-Dependent Signaling Pathway.