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Clinical Trials/NCT04788940
NCT04788940
Recruiting
Not Applicable

Clinical Implication of Cardiac Magnetic Resonance Imaging for Patients With Acute Myocardial Infarction: Prospective Observational Study

Samsung Medical Center1 site in 1 country500 target enrollmentMarch 8, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Myocardial Infarction
Sponsor
Samsung Medical Center
Enrollment
500
Locations
1
Primary Endpoint
Change from baseline in proportion of adverse/reverse remodeling at 6 months
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 8, 2021
End Date
December 31, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Young Bin Song

Professor

Samsung Medical Center

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

Outcomes

Primary Outcomes

Change from baseline in proportion of adverse/reverse remodeling at 6 months

Time Frame: at 6-month follow-up

Remodeling index assessed by baseline and follow-up CMR

Secondary Outcomes

  • 6-month hemorrhagic infarct(at 6-month follow-up)
  • Infarct size(72 hours after the index procedure)
  • Peak cardiac enzyme(72 hours after the index procedure)
  • TIMI flow(Immediate after the index procedure)
  • 6-month myocardial salvage index(at 6-month follow-up)
  • Hemorrhagic infarct(72 hours after the index procedure)
  • 6-month microvascular obstruction(at 6-month follow-up)
  • All-cause death(1-year after last patient enrollment)
  • Myocardial infarction(1-year after last patient enrollment)
  • Changes of LVEDV on CMR(at 6-month follow-up)
  • Changes of LVEDV on echocardiography(at 6-month follow-up)
  • target vessel failure(1-year after last patient enrollment)
  • Target lesion revascularization(1-year after last patient enrollment)
  • Myocardial salvage index(72 hours after the index procedure)
  • Microvascular obstruction(72 hours after the index procedure)
  • Transmurality(72 hours after the index procedure)
  • Changes of LVESV on CMR(at 6-month follow-up)
  • 6-month Infarct size(at 6-month follow-up)
  • Changes of LVEF on echocardiography(at 6-month follow-up)
  • All-cause death or heart failure readmission(1-year after last patient enrollment)
  • Target lesion failure(1-year after last patient enrollment)
  • Target vessel myocardial infarction(1-year after last patient enrollment)
  • Changes of LVESV on echocardiography(at 6-month follow-up)
  • Cardiac death or heart failure readmission(1-year after last patient enrollment)
  • Target vessel revascularization(1-year after last patient enrollment)
  • Heart failure readmission(1-year after last patient enrollment)
  • Cardiac death(1-year after last patient enrollment)
  • Any readmission(1-year after last patient enrollment)

Study Sites (1)

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