Morphine
DrugMorphine (10 mg, 10 ml) is injected around the stellate ganglion using ultrasound guidance prior to coronary artery recanalization
NCT Number: NCT07023679
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
The First Affiliated Hospital of Anhui Medical University, Hefei, China
Acute ST-segment elevation myocardial infarction (STEMI) patients (aged ≥18 years) planned for percutaneous coronary intervention (PCI) will be eligible for this study. Patients with severe complications of myocardial infarction, such as uncontrollable acute left heart failure or 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; with old myocardial infarction, or cardiomyopathy, or malignant arrhythmias controlled by antiarrhythmic drugs; with coagulation disorders due to systemic diseases and those who are currently using anticoagulants and are not suitable for injection; with allergy to opioids or with a history of opioid addiction and those participating in other clinical studies; with pregnant or breastfeeding women; with severe organ dysfunction or failure, such as liver failure, renal failure, and respiratory failure; with severe infections; with severe mental illness that cannot cooperate and those taking antipsychotic drugs or considered unsuitable for this study by the researchers will be excluded. Subjects will be randomly assigned to one of two groups: the placebo group and the morphine group. 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. Moreover, the placebo group will receive a 10 ml 0.9% saline infiltration around the stellate ganglion. The incidence of major adverse cardiovascular and cerebrovascular events (MACCE) will be recorded within one year post-surgery as the primary outcome. The secondary outcomes include plasma hs-cTnI levels, evaluation of no-reflow phenomenon, major STEMI-related complications within 30 days post-surgery, rehospitalization rate due to cardiovascular adverse events, individual events of MACCE at one year post-surgery or 30 days post-surgery, All-cause mortality, and postoperative hospital stay.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Morphine (10 mg, 10 ml) is injected around the stellate ganglion using ultrasound guidance prior to coronary artery recanalization
Saline (10 ml) is injected around the stellate ganglion using ultrasound guidance prior to coronary artery recanalization
Time frame: within one year post-surgery
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: at 24 hours post-surgery
The levels of plasma hs-cTnI will be recorded at 24 hours post-surgery.
Time frame: perioperative
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: 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 one year post-surgery
The rehospitalization rate due to cardiovascular adverse events will be recorded within one year post-surgery.
Time frame: within one year post-surgery
All-cause mortality will be recorded within one year post-surgery.
Time frame: within one year post-surgery or 30 days post-surgery
The individual event of MACCE will be recorded at one year post-surgery or 30 days post-surgery
Time frame: Perioperative
The length of the postoperative hospital stay will be determined by the duration from the completion of surgery to discharge.
Contact information is provided by the study sponsor or research team.
The Second Hospital of Anhui Medical University
Other
The Effect of Targeted Stellate Ganglion Morphine Infiltration on Reperfusion Injury in STEMI Patients After Primary PCI: A Multi-Center Randomized Controlled Trial
Acronym: tSGM-AMI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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