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 Multi-Center Randomized Controlled Trial
This trial will try giving a single morphine injection around the stellate ganglion to see if it lowers heart muscle damage and improves recovery in adults with an ST‑elevation heart attack treated with PCI.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2588 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Second Hospital of Anhui Medical University Academic / other |
| Locations | 2 sites (Hefei and 1 other locations) |
| Trial ID | NCT07023679 on ClinicalTrials.gov |
What this trial studies
Adults with acute STEMI planned for PCI within 24 hours are randomized to receive a single ultrasound‑guided injection of 10 mg morphine or saline around the left stellate ganglion before coronary recanalization. Investigators will monitor myocardial injury during the hospital stay, record symptoms and any injection‑related adverse events, and track clinical outcomes up to one year. Key exclusions include severe hemodynamic instability or mechanical complications of MI, prior MI or cardiomyopathy, coagulopathy or anticoagulant use that precludes injection, opioid allergy or addiction, pregnancy, and severe organ failure. The trial is conducted at two affiliated hospitals of Anhui Medical University in Hefei and uses placebo control and randomization to compare morphine infiltration versus saline.
Who should consider this trial
Good fit: Adults aged 18 or older with acute ST‑segment elevation myocardial infarction within 24 hours who are scheduled for PCI and can provide informed consent are the intended participants.
Not a fit: Patients with severe MI complications (like uncontrollable heart failure or mechanical rupture), coagulation disorders or anticoagulant use that prevents injection, opioid allergy or addiction, pregnancy, severe organ failure, or inability to cooperate are excluded and unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, morphine infiltration of the stellate ganglion could reduce reperfusion-related heart muscle damage and improve short‑term and one‑year outcomes after STEMI.
How similar studies have performed: Stellate ganglion modulation has shown promising results in animal studies and some human cardiac contexts (for arrhythmia or pain), but using morphine infiltration specifically to limit myocardial ischemia–reperfusion injury in acute STEMI is relatively novel with limited clinical evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hefei and 1 other locations
- The First Affiliated Hospital of Anhui Medical University — Hefei, China (Recruiting)
- The Second Affiliated Hospital of Anhui Medical University — Hefei, China (Recruiting)
Study contacts
- Study coordinator: Shiyun Jin
- 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.