Stellate Ganglion Morphine Infiltration on Myocardial Ischemia-Reperfusion Injury

NCT06947135 | Recruiting

• 1 other identifier: YX2025-048
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 3

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 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:

• 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.

Conditions

Acute Myocardial Infarction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

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

  within 30 days post-surgery

• Postoperative plasma hs-cTnI levels

  at 24 hours post-surgery

• Evaluation of no-reflow phenomenon

  at 2 hours, 24 hours or 7-day reperfusion

• The incidence of microvascular obstruction

  7 days after primary PCI or at discharge

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

  within 30 days 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 (3)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

RECRUITING

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230032, China

RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, 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, M.D., PhD.

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: April 12, 2025
• First Posted: April 27, 2025
• Study Start: May 29, 2025
• Primary Completion: June 4, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)