Stellate Ganglion Morphine Infiltration on Myocardial I/R Injury

Not Applicable

Not yet recruiting

• Conditions: Acute Myocardial Infarction (AMI)
• Interventions: Drug: Morphine; Drug: saline placebo

• Registration Number: NCT07023679
• Lead Sponsor: The Second Hospital of Anhui Medical University

Brief 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.

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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-08
• Study First Submitted QC: 2025-06-13
• Last Update Submitted: 2025-06-13
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17
• Study Start: 2025-06-20
• Primary Completion: 2029-06-20
• Study Completion: 2029-06-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2588

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Morphine group	Morphine	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.
Saline group	saline placebo	Patients in the placebo group will receive a single injection of 0.9% saline (10 ml) around the left stellate ganglion under ultrasound guidance before coronary artery recanalization.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Postoperative plasma hs-cTnI levels	at 24 hours post-surgery	The levels of plasma hs-cTnI will be recorded at 24 hours post-surgery.
Evaluation of no-reflow phenomenon	perioperative	The S-T segment deviation is measured as the height difference (in millimeters) between the J point and the baseline ( the PR segment) at 2 hours, 24 hours, and either discharge or 7 days post-surgery.
Major STEMI-related complications within 30 days post-surgery	within 30 days post-surgery	The major STEMI-related complications, including cardiogenic shock, acute left heart failure, mechanical complications, malignant arrhythmias, will be recorded within 30 days post-surgery.
Rehospitalization rate due to cardiovascular adverse events	within one year post-surgery	The rehospitalization rate due to cardiovascular adverse events will be recorded within one year post-surgery.
All-cause mortality	within one year post-surgery	All-cause mortality will be recorded within one year post-surgery.
Individual events of MACCE at one year post-surgery or 30 days post-surgery	within one year post-surgery or 30 days post-surgery	The individual event of MACCE will be recorded at one year post-surgery or 30 days post-surgery
Postoperative hospital stay	Perioperative	The length of the postoperative hospital stay will be determined by the duration from the completion of surgery to discharge.