Cardiac Magnetic ResonanceNCT06447857
Extracellular Volume Associated With New-Onset Atrial Fibrillation
An observational study of Cardiac Magnetic Resonance and Extracellular Volume Overload, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Magnetic Resonance, Extracellular Volume Overload, Myocardial Infarction
- What is being tested?
- Cardiac MRI
- How many people
- 589 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Successful pPCI (TIMI flow ≥ 2) within 12 hours after symptom onset
- Admission to the cardiac care unit for continuous electrocardiogram (ECG) monitoring after pPCI
Who cannot join
- Poor image quality
- History of myocardial infarction
- History of atrial fibrillation
- Malignancy, or inflammatory disease
- Severe valvular heart disease
- Thyroid dysfunction
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221002
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Magnetic Resonance, Extracellular Volume Overload, Myocardial Infarction, Atrial Fibrillation
- Being tested
- Cardiac MRI
- Medical subject headings
- Myocardial Infarction, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRIOther
This retrospective study included patients diagnosed with STEMI at the Affiliated Hospital of Xuzhou Medical University. All patients underwent CMR.
| Study group | Role | What they receive |
|---|---|---|
| STEMI underwent CMR | This retrospective study included patients diagnosed with STEMI at the Affiliated Hospital of Xuzhou Medical University. Receives: Other: Cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during hospitalization (assessed up to 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Jan 2020
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Magnetic ResonanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Retrospective
- Enrolment
- 589 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447857
- Sponsor's protocol ID
- XYFY2024-KL189-01
- Status last verified
- May 2024
- First submitted
- 31 May 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac MRI Extracellular Volume Associated With New-Onset Atrial Fibrillation in Patients With ST-Segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06447857
- Acronym / sponsor ID
- XYFY2024-KL189-01
- Conditions
- Cardiac Magnetic Resonance, Extracellular Volume Overload, Myocardial Infarction, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 589 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEMI underwent CMR | – | Other: Cardiac MRIThis retrospective study included patients diagnosed with STEMI at the Affiliated Hospital of Xuzhou Medical University. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Successful pPCI (TIMI flow ≥ 2) within 12 hours after symptom onset
- Admission to the cardiac care unit for continuous electrocardiogram (ECG) monitoring after pPCI
Key exclusion criteria (6 listed)
- Poor image quality
- History of myocardial infarction
- History of atrial fibrillation
- Malignancy, or inflammatory disease
- Severe valvular heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac MRIThis retrospective study included patients diagnosed with STEMI at the Affiliated Hospital of Xuzhou Medical University. All patients underwent CMR. | Other | STEMI underwent CMR |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Magnetic Resonance and Extracellular Volume Overload, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 7 Jun 2024. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint events included new-onset atrial fibrillation (time frame: during hospitalization (assessed up to 10 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2024.