NCT06447857

Brief Summary

Left ventricular fibrosis is strongly associated with atrial fibrillation (AF). However, the relationship between LV fibrosis and new-onset AF (NOAF) after ST-segment elevation myocardial infarction (STEMI) is currently unknown. This study was to investigate the relationship between different regions of ECV and NOAF during the acute phase of STEMI. ECV in integral (integral ECV), non-myocardial infarction region (NMI-ECV) and myocardial infarction region (MI-ECV) was obtained by CMR.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
589

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 7, 2024

Completed
Last Updated

June 7, 2024

Status Verified

May 1, 2024

Enrollment Period

4.4 years

First QC Date

May 31, 2024

Last Update Submit

June 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Primary endpoint events included new-onset atrial fibrillation

    NOAF was defined as post-admission atrial fibrillation without a history of atrial fibrillation. ECG monitoring revealed a suspicious rhythm during admission, and an immediate 12-lead ECG confirmed NOAF.

    during hospitalization (assessed up to 10 days)

Study Arms (1)

STEMI underwent CMR

This retrospective study included patients diagnosed with STEMI at the Affiliated Hospital of Xuzhou Medical University.

Other: Cardiac MRI

Interventions

This retrospective study included patients diagnosed with STEMI at the Affiliated Hospital of Xuzhou Medical University. All patients underwent CMR.

STEMI underwent CMR

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This retrospective study included patients diagnosed with STEMI at the Affiliated Hospital of Xuzhou Medical University from January 2020 to May 2024. All patients underwent CMR during hospitalization, which included T1 mapping sequences. The blood sampling was collected within 24 hours of the CMR examination. NOAF was defined as post-admission atrial fibrillation without a history of atrial fibrillation. ECV in integral (integral ECV), non-myocardial infarction region (NMI-ECV) and myocardial infarction region (MI-ECV) was obtained by CMR.

You may qualify if:

  • Successful pPCI (TIMI flow ≥ 2) within 12 hours after symptom onset
  • Admission to the cardiac care unit for continuous electrocardiogram (ECG) monitoring after pPCI

You may not qualify if:

  • Poor image quality
  • History of myocardial infarction
  • History of atrial fibrillation
  • Malignancy, or inflammatory disease
  • Severe valvular heart disease
  • Thyroid dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221002, China

Location

MeSH Terms

Conditions

Myocardial InfarctionAtrial Fibrillation

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisArrhythmias, Cardiac

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2024

First Posted

June 7, 2024

Study Start

January 1, 2020

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

June 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations