Morphine injection near the stellate ganglion to reduce heart damage after a heart attack
The Effect of Targeted Stellate Ganglion Morphine Infiltration on Reperfusion Injury in STEMI Patients After Primary PCI: A Randomized Controlled Trial
This trial tests whether a single injection of morphine around the stellate ganglion given before PCI can reduce heart muscle damage in adults with acute STEMI.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 166 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Second Hospital of Anhui Medical University Academic / other |
| Locations | 3 sites (Hefei, Anhui and 2 other locations) |
| Trial ID | NCT06947135 on ClinicalTrials.gov |
What this trial studies
Adults with acute ST-elevation myocardial infarction (STEMI) who are planned for primary percutaneous coronary intervention (PCI) will be randomized to receive a single ultrasound-guided injection of morphine or saline around the left stellate ganglion before coronary recanalization. Investigators will compare infarct size about 7 days after the procedure (or at discharge if sooner) and will monitor patients for safety and procedure-related complications. Key exclusions include severe post-MI complications, prior MI or cardiomyopathy, coagulation disorders, opioid allergy or dependence, pregnancy, severe organ dysfunction, and inability to consent. The trial is conducted at participating hospitals in Hefei and Changsha, China, under institutional oversight.
Who should consider this trial
Good fit: Adults aged 18 or older with acute STEMI presenting within 24 hours of chest pain who are scheduled for primary PCI and can provide informed consent are the intended candidates.
Not a fit: Patients with severe MI complications, significant bleeding or coagulation disorders, opioid allergy or dependence, pregnancy, severe organ failure, or those deemed unsuitable by investigators are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the approach could reduce infarct size and help preserve heart function after STEMI, potentially lowering complications and improving recovery.
How similar studies have performed: Modulating sympathetic activity to limit ischemia-reperfusion injury has supportive animal and limited human evidence, but direct stellate ganglion morphine infiltration in STEMI patients is a relatively novel and not widely tested approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hefei, Anhui and 2 other locations
- The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)
- The Second Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)
- The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Shiyun Jin, M.D., PhD.
- Email: xingzheruyun@126.com
- Phone: +86 055163869480
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.