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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06447857
Other study ID # XYFY2024-KL189-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date May 31, 2024

Study information

Verified date May 2024
Source The Affiliated Hospital of Xuzhou Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

This retrospective study included patients diagnosed with STEMI at the Affiliated Hospital of Xuzhou Medical University. All patients underwent CMR during hospitalization, which included T1 mapping sequences. The blood sampling was collected within 24 hours of the CMR examination. Inclusion criteria: 1. Successful pPCI (TIMI flow ≥ 2) within 12 hours after symptom onset; 2. Admission to the cardiac care unit for continuous electrocardiogram (ECG) monitoring after pPCI. Exclusion criteria: 1. Poor image quality; 2. History of myocardial infarction; 3. History of atrial fibrillation; 4. Malignancy, or inflammatory disease; 5. Severe valvular heart disease; 6. Thyroid dysfunction. 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. Infarct-related arteries (IRA) were recorded based on CAG findings. ECV in integral (integral ECV), non-myocardial infarction region (NMI-ECV) and myocardial infarction region (MI-ECV) was obtained by CMR.


Recruitment information / eligibility

Status Completed
Enrollment 589
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Successful pPCI (TIMI flow = 2) within 12 hours after symptom onset - Admission to the cardiac care unit for continuous electrocardiogram (ECG) monitoring after pPCI Exclusion Criteria: - Poor image quality - History of myocardial infarction - History of atrial fibrillation - Malignancy, or inflammatory disease - Severe valvular heart disease - Thyroid dysfunction

Study Design


Intervention

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

Locations

Country Name City State
China The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
The Affiliated Hospital of Xuzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
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