RecruitingNot ApplicableNCT06947135

Stellate Ganglion Morphine Infiltration on Myocardial Ischemia-Reperfusion Injury

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


Sponsor

The Second Hospital of Anhui Medical University

Enrollment

166 participants

Start Date

May 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to investigate whether morphine modulates the functions of the stellate ganglion to reduce myocardial ischemia/reperfusion 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 ischemia/reperfusion injury in AMI patients? 2. 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 percentage of infarct size 7 days after surgery, or at discharge if the duration is shorter than 7 days. * Record their symptoms and any major adverse cardiovascular and cerebrovascular events within 30 days post-surgery.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria9

  • 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.

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Interventions

DRUGMorphine

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

DRUGsaline placebo

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


Locations(3)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

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NCT06947135


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