- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06447857
Extracellular Volume Associated With New-Onset Atrial Fibrillation
June 5, 2024 updated by: The Affiliated Hospital of Xuzhou Medical University
Cardiac MRI Extracellular Volume Associated With New-Onset Atrial Fibrillation in Patients With ST-Segment Elevation Myocardial Infarction
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
589
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Xuzhou, Jiangsu, China, 221002
- The Affiliated Hospital of Xuzhou Medical University
-
-
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
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-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.
Description
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 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 |
Intervention / Treatment |
|---|---|
|
STEMI underwent CMR
This retrospective study included patients diagnosed with STEMI at the Affiliated Hospital of Xuzhou Medical University.
|
This retrospective study included patients diagnosed with STEMI at the Affiliated Hospital of Xuzhou Medical University.
All patients underwent CMR.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary endpoint events included new-onset atrial fibrillation
Time Frame: during hospitalization (assessed up to 10 days)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 1, 2020
Primary Completion (Actual)
May 31, 2024
Study Completion (Actual)
May 31, 2024
Study Registration Dates
First Submitted
May 31, 2024
First Submitted That Met QC Criteria
June 5, 2024
First Posted (Actual)
June 7, 2024
Study Record Updates
Last Update Posted (Actual)
June 7, 2024
Last Update Submitted That Met QC Criteria
June 5, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XYFY2024-KL189-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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