Morphine: Morphine (10 mg, 10 ml) is injected around the stellate ganglion using ultrasound guidance prior to coronary artery recanalization
saline placebo: Saline (10 ml) is injected around the stellate ganglion using ultrasound guidance prior to coronary artery recanalization
Study summary
The goal of this clinical trial is to investigate whether morphine modulates the functions of the stellate ganglion to reduce myocardial ischemia/reperfusion (I/R) injury in AMI patients. It will also assess the safety of injecting morphine around the stellate ganglion via ultrasound guidance. The main questions it aims to answer are:
1\. Does morphine regulate stellate ganglion function to reduce myocardial I/R injury in AMI patients and improve one year outcome in AMI patients? 3. What medical problems do participants experience when receiving injected morphine around the stellate ganglion? Researchers will compare morphine to a placebo saline (as a control group) to determine whether stellate ganglion infiltration with morphine effectively treats patients with AMI following primary PCI.
Participants will:
* Receive a single injection of morphine or saline around the stellate ganglion.
* Evaluate the myocardial injury during their duration of hospital stay.
* Record their symptoms and any major adverse cardiovascular and cerebrovascular events within one year post-surgery.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Aged ≥18 years, Male or Female.
* Acute ST-segment elevation myocardial infarction (STEMI) patients planned for percutaneous coronary intervention (PCI). Acute STEMI is defined as: electrocardiogram shows ST-segment elevation ≥0.2 mV in two or more adjacent leads, or new left bundle branch block (LBBW).
* Within 24 hours of the onset of infarct-related chest pain.
* Obtaining informed consent from the patient and their family.
Exclusion Criteria:
* Patients with severe complications of myocardial infarction, such as uncontrollable acute left heart failure and pulmonary edema, severe cardiogenic shock after cardiopulmonary resuscitation, severe mechanical complications including ventricular septal defect, papillary muscle rupture, and rupture of the left ventricular free wall;
* Patients with old myocardial infarction, or cardiomyopathy, or malignant arrhythmias controlled by antiarrhythmic drugs;
* Patients with coagulation disorders due to systemic diseases and those who are currently using anticoagulants and are not suitable for injection;
* Patients allergic to opioids or with a history of opioid addiction and those participating in other clinical studies;
* Pregnant or breastfeeding women;
* Patients with severe organ dysfunction or failure, such as liver failure, renal failure, and respiratory failure;
* Patients with severe infections;
* Patients with severe mental illness that cannot cooperate and those taking antipsychotic drugs;
* Other patients considered unsuitable for this study by the researchers.
Primary outcome measure(s)
The incidence of major adverse cardiovascular and cerebrovascular events (MACCE) — within one year post-surgery The incidence of major adverse cardiovascular and cerebrovascular events (MACCE), defined as cardiac death, heart failure rehospitalization, recurrent myocardial infarction, coronary revascularization, and stroke, will be recorded within one year post-surgery.
Trial sites (2)
Facility
City
Region
Status
The First Affiliated Hospital of Anhui Medical University
Hefei
China
Recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei
China
Recruiting
More The Second Hospital of Anhui Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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