Acute Myocardial Infarction (AMI)tSGM-AMINCT07023679
Stellate Ganglion Morphine Infiltration on Myocardial I/R Injury
A study testing Morphine in people with Acute Myocardial Infarction (AMI), run by The Second Hospital of Anhui Medical University at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction (AMI)
- What is being tested?
- Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,588 participants
- Where
- 2 sitesChina
- Study dates
- 24 Jun 2025to 20 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei
Yalan Fu, 86+15715510507, fynyanan77@163.com
- Recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei
Shiyun Jin, 86+63869480, xingzheruyun@126.com
About this study
Official title: The Effect of Targeted Stellate Ganglion Morphine Infiltration on Reperfusion Injury in STEMI Patients After Primary PCI: A Multi-Center Randomized Controlled 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:
- 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Acute Myocardial Infarction (AMI)
- Being tested
- Morphine, saline placebo
- Keywords
- Acute Myocardial Infarction, Stellate Ganglion, Percutaneous Coronary Intervention, Ischemia/reperfusion injury, Morphine
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Morphine (10 mg, 10 ml) is injected around the stellate ganglion using ultrasound guidance prior to coronary artery recanalization
saline placeboDrug
Saline (10 ml) is injected around the stellate ganglion using ultrasound guidance prior to coronary artery recanalization
| Study group | Role | What they receive |
|---|---|---|
| Morphine group | Experimental | 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. Receives: Drug: Morphine |
| Saline group | Placebo comparator | Patients in the placebo group will receive a single injection of 0.9% saline (10 ml) around the left stellate ganglion under ultrasound guidance before coronary artery recanalization. Receives: Drug: saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within one year post-surgery
Secondary outcomes (7)
Postoperative plasma hs-cTnI levels
The levels of plasma hs-cTnI will be recorded at 24 hours post-surgery.
Measured: at 24 hours post-surgery
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.
Measured: perioperative
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.
Measured: within 30 days post-surgery
Rehospitalization rate due to cardiovascular adverse events
The rehospitalization rate due to cardiovascular adverse events will be recorded within one year post-surgery.
Measured: within one year post-surgery
All-cause mortality
All-cause mortality will be recorded within one year post-surgery.
Measured: within one year post-surgery
Individual events of MACCE at 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
Measured: within one year post-surgery or 30 days post-surgery
Postoperative hospital stay
The length of the postoperative hospital stay will be determined by the duration from the completion of surgery to discharge.
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start24 Jun 2025
- Primary completion20 Jun 2029 (estimated)
- Study completion20 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction (AMI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,588 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ye Zhang, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023679
- Sponsor's protocol ID
- YX2025-097
- Acronym
- tSGM-AMI
- Status last verified
- Jun 2025
- First submitted
- 8 Jun 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Targeted Stellate Ganglion Morphine Infiltration on Reperfusion Injury in STEMI Patients After Primary PCI: A Multi-Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07023679
- Acronym / sponsor ID
- tSGM-AMI / YX2025-097
- Conditions
- Acute Myocardial Infarction (AMI)
- Keywords
- Acute Myocardial Infarction, Stellate Ganglion, Percutaneous Coronary Intervention, Ischemia/reperfusion injury, Morphine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,588 participants (estimated)
- Lead sponsor
- The Second Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- 20 Jun 2029 (estimated)
- Study completion
- 20 Jun 2029 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphine group | Experimental | Drug: MorphinePatients 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. |
| Saline group | Placebo comparator | Drug: saline placeboPatients in the placebo group will receive a single injection of 0.9% saline (10 ml) around the left stellate ganglion under ultrasound guidance before coronary artery recanalization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MorphineMorphine (10 mg, 10 ml) is injected around the stellate ganglion using ultrasound guidance prior to coronary artery recanalization | Drug | Morphine group |
| saline placeboSaline (10 ml) is injected around the stellate ganglion using ultrasound guidance prior to coronary artery recanalization | Drug | Saline group |
Primary outcome
The incidence of major adverse cardiovascular and cerebrovascular events (MACCE)
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.
7 secondary outcomes
Postoperative plasma hs-cTnI levels
Time frame: at 24 hours post-surgery
Evaluation of no-reflow phenomenon
Time frame: perioperative
Major STEMI-related complications within 30 days post-surgery
Time frame: within 30 days post-surgery
Rehospitalization rate due to cardiovascular adverse events
Time frame: within one year post-surgery
All-cause mortality
Time frame: within one year post-surgery
Individual events of MACCE at one year post-surgery or 30 days post-surgery
Time frame: within one year post-surgery or 30 days post-surgery
Postoperative hospital stay
Time frame: Perioperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphine in people with Acute Myocardial Infarction (AMI), run by The Second Hospital of Anhui Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shiyun Jin (+86 055163869480, xingzheruyun@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of major adverse cardiovascular and cerebrovascular events (MACCE) (time frame: within one year post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.