Stellate Ganglion Morphine Infiltration on Myocardial I/R Injury

NCT07023679 | Recruiting

• 1 other identifier: YX2025-097
• Study Type: interventional
• Target: 2,588
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Myocardial Infarction (AMI)

Keywords

Acute Myocardial Infarction; Stellate Ganglion; Percutaneous Coronary Intervention; Ischemia/reperfusion injury; Morphine

Outcome Measures

Primary Outcomes (1)

• The incidence of major adverse cardiovascular and cerebrovascular events (MACCE)

  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.

  within one year post-surgery

Secondary Outcomes (7)

• Postoperative plasma hs-cTnI levels

  at 24 hours post-surgery

• Evaluation of no-reflow phenomenon

  perioperative

• Major STEMI-related complications within 30 days post-surgery

  within 30 days post-surgery

• Rehospitalization rate due to cardiovascular adverse events

  within one year post-surgery

• All-cause mortality

  within one year post-surgery

Study Arms (2)

Morphine group

EXPERIMENTAL

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

Saline group

PLACEBO COMPARATOR

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

Interventions

Morphine DRUG

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

Morphine group

saline placebo DRUG

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

Saline group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Hospital of Anhui Medical University: lead

Study Sites (2)

The First Affiliated Hospital of Anhui Medical University

Hefei, China

RECRUITING

The Second Affiliated Hospital of Anhui Medical University

Hefei, China

RECRUITING

MeSH Terms

Conditions

Reperfusion Injury

Interventions

Morphine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Shiyun Jin

CONTACT

+86 055163869480; xingzheruyun@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior doctor

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: June 17, 2025
• Study Start: June 24, 2025
• Primary Completion (Estimated): June 20, 2029
• Study Completion (Estimated): June 20, 2029
• Last Updated: July 4, 2025

Record last verified: 2025-06

Locations

CN (2)