Stellate Ganglion Morphine Infiltration on Myocardial I/R Injury

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Second Hospital of Anhui Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Morphine

    Drug

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

  • saline placebo

    Drug

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

Treatment groups

2,588 Participants
are divided into 2 treatment groups
Group A: Morphine groupExperimental treatment 1 intervention
Group B: Saline groupPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
within one year post-surgery

Secondary outcomes

1

Postoperative plasma hs-cTnI levels

The levels of plasma hs-cTnI will be recorded at 24 hours post-surgery.

Time frame
at 24 hours post-surgery
2

Evaluation of no-reflow phenomenon

The S-T segment deviation is measured as the height difference (in millimeters) between the J point and the baseline ( the PR segment) at 2 hours, 24 hours, and either discharge or 7 days post-surgery.

Time frame
perioperative
3

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.

Time frame
within 30 days post-surgery
4

Rehospitalization rate due to cardiovascular adverse events

The rehospitalization rate due to cardiovascular adverse events will be recorded within one year post-surgery.

Time frame
within one year post-surgery

Other outcomes

Sponsors and contacts

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