NCT04788940

Brief Summary

  1. 1.To evaluate the clinical implication of cardiac magnetic resonance imaging in patients with acute myocardial infarction
  2. 2.To determine factors affecting the 6-month remodeling index assessed by cardiac magnetic resonance imaging

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

March 8, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

3.6 years

First QC Date

March 4, 2021

Last Update Submit

April 10, 2023

Conditions

Acute Myocardial Infarction

Keywords

Percutaneous Coronary InterventionAcute Myocardial InfarctionCardiac Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (28)

  • Infarct size

    72 hours after the index procedure

  • Myocardial salvage index

    72 hours after the index procedure

  • Microvascular obstruction

    72 hours after the index procedure

  • Hemorrhagic infarct

    72 hours after the index procedure

  • Transmurality

    72 hours after the index procedure

  • +23 more secondary outcomes

Study Arms (1)

AMI patients treated with PCI

Acute myocardial infarction patients who underwent percutaneous coronary intervention and cardiac magnetic resonance imaging

Procedure: Percutaneous Coronary Intervention

Interventions

Percutaneous Coronary InterventionPROCEDURE

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

AMI patients treated with PCI

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Young Bin Song, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Young Bin Song, MD, PhD

CONTACT

82-2-3410-1246youngbin.song@gmail.com

Ki Hong Choi, MD

CONTACT

82-2-3410-6653cardiokh@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 9, 2021

Study Start

March 8, 2021

Primary Completion

September 30, 2024

Study Completion

December 31, 2024

Last Updated

April 12, 2023

Record last verified: 2023-04

Locations

KR(1)