Stellate Ganglion Morphine Infiltration on Myocardial I/R Injury

Official title

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

Overview

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.

Detailed description

Acute ST-segment elevation myocardial infarction (STEMI) patients (aged ≥18 years) planned for percutaneous coronary intervention (PCI) will be eligible for this study. Patients with severe complications of myocardial infarction, such as uncontrollable acute left heart failure or 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; with old myocardial infarction, or cardiomyopathy, or malignant arrhythmias controlled by antiarrhythmic drugs; with coagulation disorders due to systemic diseases and those who are currently using anticoagulants and are not suitable for injection; with allergy to opioids or with a history of opioid addiction and those participating in other clinical studies; with pregnant or breastfeeding women; with severe organ dysfunction or failure, such as liver failure, renal failure, and respiratory failure; with severe infections; with severe mental illness that cannot cooperate and those taking antipsychotic drugs or considered unsuitable for this study by the researchers will be excluded. Subjects will be randomly assigned to one of two groups: the placebo group and the morphine group. Patients in the morphine group will receive a single injection of morphine (10 mg, 10 ml) around the left stellate ganglion under ultrasound guidance before coronary artery recanalization. Moreover, the placebo group will receive a 10 ml 0.9% saline infiltration around the stellate ganglion. The incidence of major adverse cardiovascular and cerebrovascular events (MACCE) will be recorded within one year post-surgery as the primary outcome. The secondary outcomes include plasma hs-cTnI levels, evaluation of no-reflow phenomenon, major STEMI-related complications within 30 days post-surgery, rehospitalization rate due to cardiovascular adverse events, individual events of MACCE at one year post-surgery or 30 days post-surgery, All-cause mortality, and postoperative hospital stay.

Interventions

• 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

Primary outcome measures

• The incidence of major adverse cardiovascular and cerebrovascular events (MACCE) [Time frame: within one year post-surgery]

Secondary outcome measures (7)

• Postoperative plasma hs-cTnI levels [Time frame: at 24 hours post-surgery]
• Evaluation of no-reflow phenomenon [Time frame: perioperative]
• Major STEMI-related complications within 30 days post-surgery [Time frame: within 30 days post-surgery]
• Rehospitalization rate due to cardiovascular adverse events [Time frame: within one year post-surgery]
• All-cause mortality [Time frame: within one year post-surgery]
• Individual events of MACCE at one year post-surgery or 30 days post-surgery [Time frame: within one year post-surgery or 30 days post-surgery]
• Postoperative hospital stay [Time frame: Perioperative]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 2 centers

• The First Affiliated Hospital of Anhui Medical University — Hefei
• The Second Affiliated Hospital of Anhui Medical University — Hefei

Identifiers

NCT: NCT07023679 · YX2025-097

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗