Clinical Implication CMR in AMI Registry (CMR-AMI)

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

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

Study Overview

• Status: Recruiting
• Conditions: Acute Myocardial Infarction
• Intervention / Treatment: Procedure: Percutaneous Coronary Intervention

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Ki Hong Choi, MD; Phone Number: 82-2-3410-6653; Email: cardiokh@gmail.com
• Study Contact Backup: Name: Young Bin Song, MD, PhD; Phone Number: 82-2-3410-1246; Email: youngbin.song@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center
    • Contact: Ki Hong Choi, MD; Phone Number: 82-10-8875-1648; Email: cardiokh@gmail.com
    • Contact: Young Bin Song, MD, PhD; Phone Number: 82-10-3410-3419; Email: youngbin.song@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

About 500 patients with acute myocardial infarction and who underwent PCI.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AMI patients treated with PCI; Acute myocardial infarction patients who underwent percutaneous coronary intervention and cardiac magnetic resonance imaging	Procedure: Percutaneous Coronary Intervention; Patients with AMI who underwent PCI and CMR at index hospitalization and 6-month follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in proportion of adverse/reverse remodeling at 6 months	Remodeling index assessed by baseline and follow-up CMR	at 6-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infarct size	Infarct size assessed by baseline CMR	72 hours after the index procedure
Myocardial salvage index	Myocardial salvage index assessed by baseline CMR	72 hours after the index procedure
Microvascular obstruction	Microvascular obstruction assessed by baseline CMR	72 hours after the index procedure
Hemorrhagic infarct	Hemorrhagic infarct assessed by baseline CMR	72 hours after the index procedure
Transmurality	Transmurality assessed by baseline CMR	72 hours after the index procedure
Peak cardiac enzyme	Peak cardiac enzyme at index hospitalization	72 hours after the index procedure
TIMI flow	TIMI flow grade after culprit vessel PCI	Immediate after the index procedure
Changes of LVEDV on CMR	∆left ventricular end diastolic volume assessed by baseline and follow-up CMR	at 6-month follow-up
Changes of LVESV on CMR	∆left ventricular end systolic volume assessed by baseline and follow-up CMR	at 6-month follow-up
6-month Infarct size	Infarct size assessed by 6-month CMR	at 6-month follow-up
6-month myocardial salvage index	myocardial salvage index assessed by 6-month CMR	at 6-month follow-up
6-month microvascular obstruction	6-month microvascular obstruction assessed by 6-month CMR	at 6-month follow-up
6-month hemorrhagic infarct	6-month hemorrhagic infarct assessed by 6-month CMR	at 6-month follow-up
Changes of LVEDV on echocardiography	∆left ventricular end diastolic volume assessed by baseline and follow-up echocardiography	at 6-month follow-up
Changes of LVESV on echocardiography	∆left ventricular end systolic volume assessed by baseline and follow-up echocardiography	at 6-month follow-up
Changes of LVEF on echocardiography	∆left ventricular ejection fraction assessed by baseline and follow-up echocardiography	at 6-month follow-up
Cardiac death or heart failure readmission	Cardiac death or heart failure readmission during follow-up	1-year after last patient enrollment
All-cause death or heart failure readmission	All-cause death or heart failure readmission during follow-up	1-year after last patient enrollment
Target lesion failure	a composite of cardiac death, myocardial infarction, clinically driven target lesion revascularization	1-year after last patient enrollment
target vessel failure	a composite of cardiac death, myocardial infarction, clinically driven target vessel revascularization	1-year after last patient enrollment
All-cause death	Rate of all-cause death during follow-up	1-year after last patient enrollment
Cardiac death	Rate of cardiac death during follow-up	1-year after last patient enrollment
Myocardial infarction	Myocardial infarction during follow-up	1-year after last patient enrollment
Target vessel myocardial infarction	Rate of Target vessel myocardial infarction during follow-up	1-year after last patient enrollment
Target lesion revascularization	Rate of target lesion revascularization during follow-up	1-year after last patient enrollment
Target vessel revascularization	Rate of target vessel revascularization during follow-up	1-year after last patient enrollment
Heart failure readmission	Rate of heart failure readmission during follow-up	1-year after last patient enrollment
Any readmission	Rate of any readmission during follow-up	1-year after last patient enrollment

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Young Bin Song, MD, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2021
• Primary Completion (Anticipated): September 30, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: March 4, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Acute Myocardial Infarction; Percutaneous Coronary Intervention; Cardiac Magnetic Resonance Imaging
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: CMR-AMI 2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No