Acute myocardial infarction, including ST-elevation myocardial infarction and non-ST-elevation myocardial infarction
Conditions
Interventions
None listed
Sponsors
Iwate Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients meeting all of the following criteria will be eligible: 1) age 18 years or older at the time of consent; 2) diagnosis of spontaneous acute myocardial infarction(type 1 MI) as the index event at a participating institution during the enrollment period; 3) STEMI or NSTEMI; and 4) written informed consent for study participation. If obtaining consent from the patient is difficult in the acute phase, consent may be obtained from a legally acceptable representative, followed by patient consent at a later date. Patients will be included regardless of acute treatment strategy, including PCI, CABG, or conservative management.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will be excluded: 1) acute or chronicmyocardial injury not considered acutemyocardial infarction; 2) type 2 MI mainly caused by oxygen supply-demandmismatch; 3) procedure-related MI, including type 4a, 4b, 4c, or 5 MI; 4) cases not considered spontaneous AMI causedmainly by coronary plaque rupture or erosion based on the clinical course, imaging findings, or coronary findings; and 5) suspected non-ischemic myocardial injury, including myocarditis, takotsubo syndrome, worsening heart failure, pulmonary embolism, sepsis, or myocardial injury associated with severe renal dysfunction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two-year 4-point major adverse cardiac and cerebrovascular events (4P-MACE), defined as a composite of all-cause death, myocardial infarction, stroke, and unplanned revascularization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary outcomes include 3-point hard MACE (all-cause death, non-fatal myocardial infarction, and non-fatal stroke), MACE including heart failure hospitalization(all-cause death, non-fatal myocardial infarction, non-fatal stroke, heart failure hospitalization, and unplanned revascularization), each component of the primary composite endpoint, bleeding events defined as BARC criteria, LDL-C target achievement rates at 1, 6, 12, and 24 months, and adverse events and discontinuation of PCSK9 inhibitors. | — |
Countries
Japan
Contacts
Public ContactKai Ninomiya
Iwate Medical University Division of Cardiology, Department of Internal Medicine
Outcome results
None listed