Clinical Implication CMR in AMI Registry (CMR-AMI)

April 10, 2023 updated by: Young Bin Song, Samsung Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
at 6-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Infarct size
Time Frame: 72 hours after the index procedure
Infarct size assessed by baseline CMR
72 hours after the index procedure
Myocardial salvage index
Time Frame: 72 hours after the index procedure
Myocardial salvage index assessed by baseline CMR
72 hours after the index procedure
Microvascular obstruction
Time Frame: 72 hours after the index procedure
Microvascular obstruction assessed by baseline CMR
72 hours after the index procedure
Hemorrhagic infarct
Time Frame: 72 hours after the index procedure
Hemorrhagic infarct assessed by baseline CMR
72 hours after the index procedure
Transmurality
Time Frame: 72 hours after the index procedure
Transmurality assessed by baseline CMR
72 hours after the index procedure
Peak cardiac enzyme
Time Frame: 72 hours after the index procedure
Peak cardiac enzyme at index hospitalization
72 hours after the index procedure
TIMI flow
Time Frame: Immediate after the index procedure
TIMI flow grade after culprit vessel PCI
Immediate after the index procedure
Changes of LVEDV on CMR
Time Frame: at 6-month follow-up
∆left ventricular end diastolic volume assessed by baseline and follow-up CMR
at 6-month follow-up
Changes of LVESV on CMR
Time Frame: at 6-month follow-up
∆left ventricular end systolic volume assessed by baseline and follow-up CMR
at 6-month follow-up
6-month Infarct size
Time Frame: at 6-month follow-up
Infarct size assessed by 6-month CMR
at 6-month follow-up
6-month myocardial salvage index
Time Frame: at 6-month follow-up
myocardial salvage index assessed by 6-month CMR
at 6-month follow-up
6-month microvascular obstruction
Time Frame: at 6-month follow-up
6-month microvascular obstruction assessed by 6-month CMR
at 6-month follow-up
6-month hemorrhagic infarct
Time Frame: at 6-month follow-up
6-month hemorrhagic infarct assessed by 6-month CMR
at 6-month follow-up
Changes of LVEDV on echocardiography
Time Frame: at 6-month follow-up
∆left ventricular end diastolic volume assessed by baseline and follow-up echocardiography
at 6-month follow-up
Changes of LVESV on echocardiography
Time Frame: at 6-month follow-up
∆left ventricular end systolic volume assessed by baseline and follow-up echocardiography
at 6-month follow-up
Changes of LVEF on echocardiography
Time Frame: at 6-month follow-up
∆left ventricular ejection fraction assessed by baseline and follow-up echocardiography
at 6-month follow-up
Cardiac death or heart failure readmission
Time Frame: 1-year after last patient enrollment
Cardiac death or heart failure readmission during follow-up
1-year after last patient enrollment
All-cause death or heart failure readmission
Time Frame: 1-year after last patient enrollment
All-cause death or heart failure readmission during follow-up
1-year after last patient enrollment
Target lesion failure
Time Frame: 1-year after last patient enrollment
a composite of cardiac death, myocardial infarction, clinically driven target lesion revascularization
1-year after last patient enrollment
target vessel failure
Time Frame: 1-year after last patient enrollment
a composite of cardiac death, myocardial infarction, clinically driven target vessel revascularization
1-year after last patient enrollment
All-cause death
Time Frame: 1-year after last patient enrollment
Rate of all-cause death during follow-up
1-year after last patient enrollment
Cardiac death
Time Frame: 1-year after last patient enrollment
Rate of cardiac death during follow-up
1-year after last patient enrollment
Myocardial infarction
Time Frame: 1-year after last patient enrollment
Myocardial infarction during follow-up
1-year after last patient enrollment
Target vessel myocardial infarction
Time Frame: 1-year after last patient enrollment
Rate of Target vessel myocardial infarction during follow-up
1-year after last patient enrollment
Target lesion revascularization
Time Frame: 1-year after last patient enrollment
Rate of target lesion revascularization during follow-up
1-year after last patient enrollment
Target vessel revascularization
Time Frame: 1-year after last patient enrollment
Rate of target vessel revascularization during follow-up
1-year after last patient enrollment
Heart failure readmission
Time Frame: 1-year after last patient enrollment
Rate of heart failure readmission during follow-up
1-year after last patient enrollment
Any readmission
Time Frame: 1-year after last patient enrollment
Rate of any readmission during follow-up
1-year after last patient enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Samsung Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Young Bin Song, MD, PhD, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 8, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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