Stellate Ganglion Morphine Infiltration on Myocardial Ischemia-Reperfusion Injury (tSGM-AMI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Myocardial Infarction
• Intervention / Treatment: Drug: Morphine; Drug: saline placebo

Detailed Description

Acute ST-segment elevation myocardial infarction (STEMI) patients (aged ≥18 years) planned for percutaneous coronary intervention (PCI) will be enrolled 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; 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 percentage of myocardial infarct size is measured by MRI either 7 days after primary PCI or at discharge if the duration is shorter than 7 days as the primary outcome. The secondary outcomes include the rate of major adverse cardiovascular and cerebrovascular events, cardiac function, rehospitalization rate, and mortality within 30 days; evaluation of myocardial injury during hospitalization, including cTnI levels and ECG examinations.

• Study Type: Interventional
• Enrollment (Estimated): 166
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shiyun Jin, M.D., PhD.; Phone Number: +86 055163869480; Email: xingzheruyun@126.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • Recruiting
      • The First Affiliated Hospital of Anhui Medical University
      • Contact: Yalan Fu; Phone Number: 86+15715510507; Email: fynyanan77@163.com
    • Hefei, Anhui, China, 230032
      • Recruiting
      • The Second Affiliated Hospital of Anhui Medical University
      • Contact: Shiyun Jin; Phone Number: 86+63869480; Email: xingzheruyun@126.com
  • Hunan
    • Changsha, Hunan, China, 410011
      • Recruiting
      • The second Xiangya hospital of central south university
      • Contact: Yiyang Tang; Phone Number: 13207310992; Email: 251660870@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged ≥18 years, Male or Female.
2. 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).
3. Within 24 hours of the onset of infarct-related chest pain.
4. Obtaining informed consent from the patient and their family.

Exclusion Criteria:

1. 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;
2. Patients with old myocardial infarction, or cardiomyopathy, or malignant arrhythmias controlled by antiarrhythmic drugs;
3. Patients with coagulation disorders due to systemic diseases and those who are currently using anticoagulants and are not suitable for injection;
4. Patients allergic to opioids or with a history of opioid addiction and those participating in other clinical studies;
5. Pregnant or breastfeeding women;
6. Patients with severe organ dysfunction or failure, such as liver failure, renal failure, and respiratory failure;
7. Patients with severe infections;
8. Patients with severe mental illness that cannot cooperate and those taking antipsychotic drugs;
9. Other patients considered unsuitable for this study by the researchers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Morphine; Morphine (10 mg, 10 ml) is injected around the stellate ganglion using ultrasound guidance prior to coronary artery recanalization
Placebo Comparator: Saline group; 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.	Drug: saline placebo; Saline (10 ml) is injected around the stellate ganglion using ultrasound guidance prior to coronary artery recanalization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of myocardial infarct size	The percentage of myocardial infarct size is measured by MRI either 7 days after primary PCI or at discharge if the duration is shorter than 7 days.	7 days after primary PCI or at discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of major adverse cardiovascular and cerebrovascular events (MACCE)	The incidence of MACCE, including cardiac death, rehospitalization for heart failure, recurrent myocardial infarction, coronary revascularization, and stroke, will be recorded within 30 days post-surgery.	within 30 days post-surgery
Postoperative plasma hs-cTnI levels	The levels of plasma hs-cTnI will be recorded at 24 hours post-surgery.	at 24 hours post-surgery
Evaluation of no-reflow phenomenon	The ST segment resolution will be evaluated by electrocardiograph (ECG) at 2 hours, 24 hours or 7-day reperfusion.	at 2 hours, 24 hours or 7-day reperfusion
The incidence of microvascular obstruction	The incidence of microvascular obstruction is evaluated by MRI either 7 days after primary PCI or at discharge if the duration is shorter than 7 days.	7 days after primary PCI or at discharge
Major STEMI-related complications 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.	within 30 days post-surgery
Rehospitalization rate due to cardiovascular adverse events	The rehospitalization rate due to cardiovascular adverse events will be recorded within 30 days post-surgery.	within 30 days post-surgery
All-cause mortality	All-cause mortality will be recorded within 30 days post-surgery.	within 30 days post-surgery

Collaborators and Investigators

• Sponsor: The Second Hospital of Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2025
• Primary Completion (Estimated): June 4, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 12, 2025
• First Submitted That Met QC Criteria: April 19, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Acute Myocardial Infarction; Percutaneous Coronary Intervention; Morphine; Stellate Ganglion; Ischemia/reperfusion injury
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Reperfusion Injury; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Morphine Derivatives; Morphine
• Other Study ID Numbers: YX2025-048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No