Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-02-26 @ 2:15 AM
Study NCT ID:
NCT06399666
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Inflammatory Indexes and Gene Scores in Prediction of Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D020022', 'term': 'Genetic Predisposition to Disease'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004198', 'term': 'Disease Susceptibility'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 182}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-11', 'studyFirstSubmitDate': '2024-04-30', 'studyFirstSubmitQcDate': '2024-04-30', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of AF', 'timeFrame': 'During follow-up (post ECV, day 7, 30, 90, and 180)', 'description': 'Recurrence of atrial fibrillation or atrial flutter recorded on 12-lead ECG or through pacemaker interpretation'}], 'secondaryOutcomes': [{'measure': 'Fluctuations of biomarkers and gene expression during follow-up', 'timeFrame': 'During follow-up (post ECV, day 7, 30, 90, and 180)', 'description': 'Change in biomarker level or expression of gene expressions during follow-up.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation', 'Inflammation', 'Genetic Predisposition to Disease']}, 'descriptionModule': {'briefSummary': 'Because of the high recurrence rates following electrical cardioversion and high morbidity in AF patients there is a need to explore prediction models for AF recurrence following ECV. Previous studies have primarily focused on high-sensitivity CRP (hsCRP), CRP, and IL-6, while other inflammatory indexes and gene scores might hold greater value.\n\nThis prospective cohort study is planning to include 182 patients with persistent atrial fibrillation, planned for electrical cardioversion, and \\>18 years at two medium-sized hospitals in Sweden. Blood samples will be collected prior to electrical cardioversion and at 7-, 30-, 90-, and 180-days follow-up. Atrial fibrillation recurrence will be evaluated at follow-up or upon patient request and diagnosed with 12-lead ECG.\n\nAn interim analysis will be conducted after more than 80 patients have been included. If the results from univariate and/or multivariable logistic regression on inflammatory markers and genetic expression regarding atrial fibrillation recurrence are significant, the study will be concluded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study included patients aged 18 or older diagnosed with persistent atrial fibrillation (ICD-10 I48.1) scheduled for ECV. Inclusion took place from 2023-10-18 to 2025-06-01.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persistent atrial fibrillation (ICD-10 I48.1)\n* Age over 18 years\n\nExclusion Criteria:\n\n* Autoimmune disease\n* Inflammatory diseases\n* Acute or chronic liver dysfunction\n* Ongoing infectious diseases\n* Thyroid disorders\n* Any other conditions known to impact inflammatory activity (including medication use and hematological diseases)'}, 'identificationModule': {'nctId': 'NCT06399666', 'acronym': 'IERV', 'briefTitle': 'Impact of Inflammatory Indexes and Gene Scores in Prediction of Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Vrinnevi Hospital'}, 'officialTitle': 'Impact of Inflammatory Indexes and Gene Scores in Prediction of Atrial Fibrillation - IERV Trial', 'orgStudyIdInfo': {'id': 'Dnr 2023-02252-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prospective cohort', 'description': 'Prospective cohort measuring the previously described biomarkers.', 'interventionNames': ['Other: Blood sampling']}], 'interventions': [{'name': 'Blood sampling', 'type': 'OTHER', 'description': 'Blood sampling', 'armGroupLabels': ['Prospective cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jönköping', 'state': 'Småland', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Jakob Hytting, MD', 'role': 'CONTACT', 'email': 'jakob.hytting@liu.se'}], 'facility': 'Medical department', 'geoPoint': {'lat': 57.78145, 'lon': 14.15618}}, {'city': 'Norrköping', 'state': 'Östergötland County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Jakob Hytting, MD', 'role': 'CONTACT', 'email': 'jakob.hytting@liu.se'}], 'facility': 'Cardiology Clinic', 'geoPoint': {'lat': 58.59419, 'lon': 16.1826}}], 'centralContacts': [{'name': 'Jakob Hytting, MD', 'role': 'CONTACT', 'email': 'jakob.hytting@liu.se', 'phone': '+46 + 707679724'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vrinnevi Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ryhov County Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Department of Cardiology, Principal Investigator, Doctoral Candidate', 'investigatorFullName': 'Jakob Hytting', 'investigatorAffiliation': 'Vrinnevi Hospital'}}}}