Stellate Ganglion Morphine Infiltration on Myocardial Ischemia-Reperfusion Injury

Официальное название

The Effect of Targeted Stellate Ganglion Morphine Infiltration on Reperfusion Injury in STEMI Patients After Primary PCI: A Randomized Controlled Trial

Обзор

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: 1. Does morphine regulate stellate ganglion function to reduce myocardial ischemia/reperfusion injury in AMI patients? 2. 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 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.

Подробное описание

Acute ST-segment elevation myocardial infarction (STEMI) patients (aged ≥18 years) planned for percutaneous coronary intervention (PCI) will be enrolled 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; 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 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 as the primary outcome. The secondary outcomes include the rate of major adverse cardiovascular and cerebrovascular events, cardiac function, rehospitalization rate, and mortality within 30 days; evaluation of myocardial injury during hospitalization, including cTnI levels and ECG examinations.

Вмешательства

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

Первичные конечные точки

• The percentage of myocardial infarct size [Срок оценки: 7 days after primary PCI or at discharge]

Вторичные конечные точки (7)

• The incidence of major adverse cardiovascular and cerebrovascular events (MACCE) [Срок оценки: within 30 days post-surgery]
• Postoperative plasma hs-cTnI levels [Срок оценки: at 24 hours post-surgery]
• Evaluation of no-reflow phenomenon [Срок оценки: at 2 hours, 24 hours or 7-day reperfusion]
• The incidence of microvascular obstruction [Срок оценки: 7 days after primary PCI or at discharge]
• Major STEMI-related complications within 30 days post-surgery [Срок оценки: within 30 days post-surgery]
• Rehospitalization rate due to cardiovascular adverse events [Срок оценки: within 30 days post-surgery]
• All-cause mortality [Срок оценки: within 30 days post-surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• The First Affiliated Hospital of Anhui Medical University — Хэфэй
• The Second Affiliated Hospital of Anhui Medical University — Хэфэй
• The Second Xiangya Hospital of Central South University — Чанша

Идентификаторы

NCT: NCT06947135 · YX2025-048

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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