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Acute Myocardial InfarctionCMR-AMINCT04788940

Clinical Implication CMR in AMI Registry

An observational study of Acute Myocardial Infarction, run by Samsung Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
Percutaneous Coronary Intervention
Type of treatment
Surgery or procedure
How many people
500 participants
Where
1 siteSouth Korea
Study dates
8 Mar 2021to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Young Bin Song, MD, PhD contact

82-2-3410-1246

youngbin.song@gmail.com

Ki Hong Choi, MD contact

82-2-3410-6653

cardiokh@gmail.com

South Korea1 site, 1 recruiting

  • Samsung Medical Center

    Seoul, 06351

    Young Bin Song, MD, PhD, 82-10-3410-3419, youngbin.song@gmail.com

    Ki Hong Choi, MD, 82-10-8875-1648, cardiokh@gmail.com

    Recruiting

Other trials in South Korea

About this study

Official title: 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
Read the 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.

Being tested
Percutaneous Coronary Intervention
Keywords
Percutaneous Coronary Intervention, Acute Myocardial Infarction, Cardiac Magnetic Resonance Imaging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous Coronary InterventionProcedure or surgery

    Patients with AMI who underwent PCI and CMR at index hospitalization and 6-month follow-up

Study groups in NCT04788940
Study groupRoleWhat they receive
AMI patients treated with PCIAcute myocardial infarction patients who underwent percutaneous coronary intervention and cardiac magnetic resonance imaging
Receives: Procedure: Percutaneous Coronary Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Remodeling index assessed by baseline and follow-up CMR

    Measured: at 6-month follow-up

Secondary outcomes (28)

  1. Infarct size

    Infarct size assessed by baseline CMR

    Measured: 72 hours after the index procedure

  2. Myocardial salvage index

    Myocardial salvage index assessed by baseline CMR

    Measured: 72 hours after the index procedure

  3. Microvascular obstruction

    Microvascular obstruction assessed by baseline CMR

    Measured: 72 hours after the index procedure

  4. Hemorrhagic infarct

    Hemorrhagic infarct assessed by baseline CMR

    Measured: 72 hours after the index procedure

  5. Transmurality

    Transmurality assessed by baseline CMR

    Measured: 72 hours after the index procedure

  6. Peak cardiac enzyme

    Peak cardiac enzyme at index hospitalization

    Measured: 72 hours after the index procedure

  7. TIMI flow

    TIMI flow grade after culprit vessel PCI

    Measured: Immediate after the index procedure

  8. Changes of LVEDV on CMR

    ∆left ventricular end diastolic volume assessed by baseline and follow-up CMR

    Measured: at 6-month follow-up

  9. Changes of LVESV on CMR

    ∆left ventricular end systolic volume assessed by baseline and follow-up CMR

    Measured: at 6-month follow-up

  10. 6-month Infarct size

    Infarct size assessed by 6-month CMR

    Measured: at 6-month follow-up

  11. 6-month myocardial salvage index

    myocardial salvage index assessed by 6-month CMR

    Measured: at 6-month follow-up

  12. 6-month microvascular obstruction

    6-month microvascular obstruction assessed by 6-month CMR

    Measured: at 6-month follow-up

  13. 6-month hemorrhagic infarct

    6-month hemorrhagic infarct assessed by 6-month CMR

    Measured: at 6-month follow-up

  14. Changes of LVEDV on echocardiography

    ∆left ventricular end diastolic volume assessed by baseline and follow-up echocardiography

    Measured: at 6-month follow-up

  15. Changes of LVESV on echocardiography

    ∆left ventricular end systolic volume assessed by baseline and follow-up echocardiography

    Measured: at 6-month follow-up

  16. Changes of LVEF on echocardiography

    ∆left ventricular ejection fraction assessed by baseline and follow-up echocardiography

    Measured: at 6-month follow-up

  17. Cardiac death or heart failure readmission

    Cardiac death or heart failure readmission during follow-up

    Measured: 1-year after last patient enrollment

  18. All-cause death or heart failure readmission

    All-cause death or heart failure readmission during follow-up

    Measured: 1-year after last patient enrollment

  19. Target lesion failure

    a composite of cardiac death, myocardial infarction, clinically driven target lesion revascularization

    Measured: 1-year after last patient enrollment

  20. target vessel failure

    a composite of cardiac death, myocardial infarction, clinically driven target vessel revascularization

    Measured: 1-year after last patient enrollment

  21. All-cause death

    Rate of all-cause death during follow-up

    Measured: 1-year after last patient enrollment

  22. Cardiac death

    Rate of cardiac death during follow-up

    Measured: 1-year after last patient enrollment

  23. Myocardial infarction

    Myocardial infarction during follow-up

    Measured: 1-year after last patient enrollment

  24. Target vessel myocardial infarction

    Rate of Target vessel myocardial infarction during follow-up

    Measured: 1-year after last patient enrollment

  25. Target lesion revascularization

    Rate of target lesion revascularization during follow-up

    Measured: 1-year after last patient enrollment

  26. Target vessel revascularization

    Rate of target vessel revascularization during follow-up

    Measured: 1-year after last patient enrollment

  27. Heart failure readmission

    Rate of heart failure readmission during follow-up

    Measured: 1-year after last patient enrollment

  28. Any readmission

    Rate of any readmission during follow-up

    Measured: 1-year after last patient enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2021
  2. Study start8 Mar 2021
  3. Primary completion30 Sep 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04788940
Sponsor's protocol ID
CMR-AMI 2021
Acronym
CMR-AMI
Status last verified
Apr 2023
First submitted
4 Mar 2021
Last updated
12 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Myocardial Infarction, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Young Bin Song, MD, PhD (82-2-3410-1246, youngbin.song@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in proportion of adverse/reverse remodeling at 6 months (time frame: at 6-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04788940.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.

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