Clinical Implication CMR in AMI Registry
- Conditions
- Acute Myocardial Infarction
- Interventions
- Procedure: Percutaneous Coronary Intervention
- Registration Number
- NCT04788940
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
1. To evaluate the clinical implication of cardiac magnetic resonance imaging in patients with acute myocardial infarction
2. To determine factors affecting the 6-month remodeling index assessed by cardiac magnetic resonance imaging
- Detailed Description
To date, advances in medical treatment and reperfusion therapy led to markedly decreased morbidity and mortality rate in patients with acute myocardial infarction (AMI). Nevertheless, there is a deterioration of left ventricular systolic function or development of heart failure in 40-50% of surviving patients with AMI after the percutaneous coronary intervention (PCI), and it is related to infarct size at the index procedure. Conventional methods of measuring the infarct size included electrocardiogram, peak cardiac enzyme, and echocardiography, but these do not indicate the exact irreversible tissue damage and only suggest indirect parameters. However, cardiac magnetic resonance imaging (CMR) provides information on infarct size, microvascular obstruction, transmurality, and salvage index, and discriminative function between viable and non-viable myocardium with high spatial resolution. Also, magnetic resonance imaging is used as a gold standard for the evaluation of the myocardial remodeling index. However, it is not well known in which patients occur adverse remodeling for the myocardium and in which patients occur reverse remodeling. Therefore, the investigators sought to evaluate the clinical implication of CMR and to determine factors affecting the 6-month remodeling index assessed by cardiac magnetic resonance imaging through the current registry.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Subjects diagnosed as type 1 myocardial infarction the presence of acute myocardial injury detected by abnormal cardiac biomarkers in the setting of evidence of acute myocardial ischemia.
- Patients who cannot perform cardiac magnetic resonance imaging
- Target vessel is not suitable for coronary intervention
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description AMI patients treated with PCI Percutaneous Coronary Intervention Acute myocardial infarction patients who underwent percutaneous coronary intervention and cardiac magnetic resonance imaging
- Primary Outcome Measures
Name Time Method Change from baseline in proportion of adverse/reverse remodeling at 6 months at 6-month follow-up Remodeling index assessed by baseline and follow-up CMR
- Secondary Outcome Measures
Name Time Method 6-month hemorrhagic infarct at 6-month follow-up 6-month hemorrhagic infarct assessed by 6-month CMR
Infarct size 72 hours after the index procedure Infarct size assessed by baseline CMR
Peak cardiac enzyme 72 hours after the index procedure Peak cardiac enzyme at index hospitalization
TIMI flow Immediate after the index procedure TIMI flow grade after culprit vessel PCI
6-month myocardial salvage index at 6-month follow-up myocardial salvage index assessed by 6-month CMR
Hemorrhagic infarct 72 hours after the index procedure Hemorrhagic infarct assessed by baseline CMR
6-month microvascular obstruction at 6-month follow-up 6-month microvascular obstruction assessed by 6-month CMR
All-cause death 1-year after last patient enrollment Rate of all-cause death during follow-up
Myocardial infarction 1-year after last patient enrollment Myocardial infarction during follow-up
Changes of LVEDV on CMR at 6-month follow-up ∆left ventricular end diastolic volume assessed by baseline and follow-up CMR
Changes of LVEDV on echocardiography at 6-month follow-up ∆left ventricular end diastolic volume assessed by baseline and follow-up echocardiography
target vessel failure 1-year after last patient enrollment a composite of cardiac death, myocardial infarction, clinically driven target vessel revascularization
Target lesion revascularization 1-year after last patient enrollment Rate of target lesion revascularization during follow-up
Myocardial salvage index 72 hours after the index procedure Myocardial salvage index assessed by baseline CMR
Microvascular obstruction 72 hours after the index procedure Microvascular obstruction assessed by baseline CMR
Transmurality 72 hours after the index procedure Transmurality assessed by baseline CMR
Changes of LVESV on CMR at 6-month follow-up ∆left ventricular end systolic volume assessed by baseline and follow-up CMR
6-month Infarct size at 6-month follow-up Infarct size assessed by 6-month CMR
Changes of LVEF on echocardiography at 6-month follow-up ∆left ventricular ejection fraction assessed by baseline and follow-up echocardiography
All-cause death or heart failure readmission 1-year after last patient enrollment All-cause death or heart failure readmission during follow-up
Target lesion failure 1-year after last patient enrollment a composite of cardiac death, myocardial infarction, clinically driven target lesion revascularization
Target vessel myocardial infarction 1-year after last patient enrollment Rate of Target vessel myocardial infarction during follow-up
Changes of LVESV on echocardiography at 6-month follow-up ∆left ventricular end systolic volume assessed by baseline and follow-up echocardiography
Cardiac death or heart failure readmission 1-year after last patient enrollment Cardiac death or heart failure readmission during follow-up
Target vessel revascularization 1-year after last patient enrollment Rate of target vessel revascularization during follow-up
Heart failure readmission 1-year after last patient enrollment Rate of heart failure readmission during follow-up
Cardiac death 1-year after last patient enrollment Rate of cardiac death during follow-up
Any readmission 1-year after last patient enrollment Rate of any readmission during follow-up
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of