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RECRUITINGINTERVENTIONAL

Stellate Ganglion Morphine Infiltration on Myocardial I/R Injury

The Effect of Targeted Stellate Ganglion Morphine Infiltration on Reperfusion Injury in STEMI Patients After Primary PCI: A Multi-Center Randomized Controlled Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form from the patient and their family. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Morphine

Morphine (10 mg, 10 ml) is injected around the stellate ganglion using ultrasound guidance prior to coronary artery recanalization

DRUG

saline placebo

Saline (10 ml) is injected around the stellate ganglion using ultrasound guidance prior to coronary artery recanalization

Locations (2)

The First Affiliated Hospital of Anhui Medical University
Hefei, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, China