Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-04-05 @ 10:08 AM
Study NCT ID:
NCT06447857
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2024-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extracellular Volume Associated With New-Onset Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 589}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-05', 'studyFirstSubmitDate': '2024-05-31', 'studyFirstSubmitQcDate': '2024-06-05', 'lastUpdatePostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary endpoint events included new-onset atrial fibrillation', 'timeFrame': 'during hospitalization (assessed up to 10 days)', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Magnetic Resonance', 'Extracellular Volume Overload', 'Myocardial Infarction', 'Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Successful pPCI (TIMI flow ≥ 2) within 12 hours after symptom onset\n* Admission to the cardiac care unit for continuous electrocardiogram (ECG) monitoring after pPCI\n\nExclusion Criteria:\n\n* Poor image quality\n* History of myocardial infarction\n* History of atrial fibrillation\n* Malignancy, or inflammatory disease\n* Severe valvular heart disease\n* Thyroid dysfunction'}, 'identificationModule': {'nctId': 'NCT06447857', 'briefTitle': 'Extracellular Volume Associated With New-Onset Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of Xuzhou Medical University'}, 'officialTitle': 'Cardiac MRI Extracellular Volume Associated With New-Onset Atrial Fibrillation in Patients With ST-Segment Elevation Myocardial Infarction', 'orgStudyIdInfo': {'id': 'XYFY2024-KL189-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'STEMI underwent CMR', 'description': 'This retrospective study included patients diagnosed with STEMI at the Affiliated Hospital of Xuzhou Medical University.', 'interventionNames': ['Other: Cardiac MRI']}], 'interventions': [{'name': 'Cardiac MRI', 'type': 'OTHER', 'description': 'This retrospective study included patients diagnosed with STEMI at the Affiliated Hospital of Xuzhou Medical University. All patients underwent CMR.', 'armGroupLabels': ['STEMI underwent CMR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '221002', 'city': 'Xuzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The Affiliated Hospital of Xuzhou Medical University', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of Xuzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}