Clinical Implication CMR in AMI Registry

Acute Myocardial Infarction Clinical Trial

— CMR-AMI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04788940
• Other study ID #: CMR-AMI 2021
• Status: Recruiting
• Start date: March 8, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Samsung Medical Center
• Contact: Young Bin Song, MD, PhD
• Phone: 82-2-3410-1246
• Email: youngbin.song[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Procedure:
• Percutaneous Coronary Intervention
Patients with AMI who underwent PCI and CMR at index hospitalization and 6-month follow-up

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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