Clinical trial NCT04788940: Clinical Implication CMR in AMI Registry
Official title: Clinical Implication of Cardiac Magnetic Resonance Imaging for Patients With Acute Myocardial Infarction: Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myocardial Infarction
Keywords: Percutaneous Coronary Intervention
Acute Myocardial Infarction
Cardiac Magnetic Resonance Imaging
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 500
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: About 500 patients with acute myocardial infarction and who underwent PCI.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients who cannot perform cardiac magnetic resonance imaging
* Target vessel is not suitable for coronary intervention

Primary outcomes:
measure: Change from baseline in proportion of adverse/reverse remodeling at 6 months
timeFrame: at 6-month follow-up
Secondary outcomes:
measure: Infarct size
timeFrame: 72 hours after the index procedure
measure: Myocardial salvage index
timeFrame: 72 hours after the index procedure
measure: Microvascular obstruction
timeFrame: 72 hours after the index procedure
measure: Hemorrhagic infarct
timeFrame: 72 hours after the index procedure
measure: Transmurality
timeFrame: 72 hours after the index procedure
measure: Peak cardiac enzyme
timeFrame: 72 hours after the index procedure
measure: TIMI flow
timeFrame: Immediate after the index procedure
measure: Changes of LVEDV on CMR
timeFrame: at 6-month follow-up
measure: Changes of LVESV on CMR
timeFrame: at 6-month follow-up
measure: 6-month Infarct size
timeFrame: at 6-month follow-up
measure: 6-month myocardial salvage index
timeFrame: at 6-month follow-up
measure: 6-month microvascular obstruction
timeFrame: at 6-month follow-up
measure: 6-month hemorrhagic infarct
timeFrame: at 6-month follow-up
measure: Changes of LVEDV on echocardiography
timeFrame: at 6-month follow-up
measure: Changes of LVESV on echocardiography
timeFrame: at 6-month follow-up
measure: Changes of LVEF on echocardiography
timeFrame: at 6-month follow-up
measure: Cardiac death or heart failure readmission
timeFrame: 1-year after last patient enrollment
measure: All-cause death or heart failure readmission
timeFrame: 1-year after last patient enrollment
measure: Target lesion failure
timeFrame: 1-year after last patient enrollment
measure: target vessel failure
timeFrame: 1-year after last patient enrollment
measure: All-cause death
timeFrame: 1-year after last patient enrollment
measure: Cardiac death
timeFrame: 1-year after last patient enrollment
measure: Myocardial infarction
timeFrame: 1-year after last patient enrollment
measure: Target vessel myocardial infarction
timeFrame: 1-year after last patient enrollment
measure: Target lesion revascularization
timeFrame: 1-year after last patient enrollment
measure: Target vessel revascularization
timeFrame: 1-year after last patient enrollment
measure: Heart failure readmission
timeFrame: 1-year after last patient enrollment
measure: Any readmission
timeFrame: 1-year after last patient enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Young Bin Song, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: