Patients with acute ST-segment elevation myocardial infarction
Conditions
Interventions
Trial Group (Intravascular Imaging Guidance Group):During emergency primary percutaneous coronary intervention (PCI) in patients with acute ST-elevation myocardial infarction (STEMI), intravascular im
Control Group (Coronary Angiography Guidance Group):During emergency primary percutaneous coronary intervention (PCI) in patients with acute ST-elevation myocardial infarction (STEMI), coronary angiog
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. Diagnose patients with acute ST segment elevation myocardial infarction with indications for emergency intervention therapy (1. The diagnostic criteria for myocardial infarction are based on the fourth edition of the global definition of myocardial infarction; 2. For typical STEMI electrocardiogram diagnostic criteria: excluding left bundle branch block and hypertrophic cardiomyopathy, at least two adjacent leads should have new ST segment elevation (elevation amplitude meets any of the following criteria): (1) adjacent chest leads (non-V2-V3 leads) or limb leads with ST segment elevation >= 1 mm; (2) ST segment elevation >= 2.5 mm (= 2 mm (>= 40 years, male) or >= 1.5 mm (female) in leads V2-V3; 3. Subjects may receive direct percutaneous coronary intervention (1. STEMI patients within 12 hours of onset; 2. STEMI patients who have successfully recovered from out of hospital cardiac arrest; 3. STEMI patients who have been diagnosed for more than 12 hours but have clinical and/or electrocardiographic evidence of progressive ischemia, persistent myocardial ischemia symptoms, hemodynamic instability, or fatal arrhythmias); 4. Participants or authorized family members voluntarily accept the clinical trial and sign a written informed consent form; 5. It is expected that the intracavitary imaging catheter can complete the examination through the target lesion;
Exclusion criteria
Exclusion criteria: 1. Cardiogenic shock or severe heart failure (Killip IV grade); 2. Patients who have undergone coronary artery bypass grafting (CABG) in the past; 3. Coma or consciousness disorder patients; 4. Expected to be intolerant to long-term antiplatelet therapy in patients; 5. pregnant women; 6. Expected survival time<1 year; 7. Currently participating in clinical trials of other drugs/devices and not meeting the primary endpoint; 8. Poor compliance, expected inability to complete follow-up;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Cardiovascular Adverse Events (MACE) One Year After PCI Surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Revascularization;Readmission for cardiovascular disease;Major cardiovascular adverse events (MACE) 2 years after PCI surgery;Myocardial infarction;Death;Major cardiovascular adverse events (MACE) 5 years after PCI surgery; | — |
Countries
China
Contacts
Public ContactGe Junbo
Zhongshan Hospital, Fudan University
Outcome results
None listed