Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-06 @ 2:45 PM
Study NCT ID:
NCT07437456
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AF-CARD Registry (Real-World Clinical Practice Registry of Patients With Atrial Fibrillation)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3500}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-22', 'studyFirstSubmitDate': '2026-02-22', 'studyFirstSubmitQcDate': '2026-02-22', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative incidence of thromboembolic complications', 'timeFrame': '6, 12, 18, 24, 30, 36 month', 'description': 'To assess the cumulative incidence of atrial fibrillation-related thromboembolic complications (including transient ischaemic attack, ischaemic stroke, and systemic thromboembolism) in patients with initially low risk over the follow-up period.'}], 'secondaryOutcomes': [{'measure': 'Number of Atrial Fibrillation Paroxysms During the Follow-up Period', 'timeFrame': '6, 12, 18, 24, 30, 36 month', 'description': 'To assess the number of documented episodes (paroxysms) of atrial fibrillation in patients at each visit throughout the follow-up period.'}, {'measure': 'Rate of Hospitalizations Due to Atrial Fibrillation Paroxysm During the Follow-up Period', 'timeFrame': '6, 12, 18, 24, 30, 36 months', 'description': 'To assess the number of hospitalizations associated with atrial fibrillation paroxysm in patients at each visit throughout the follow-up period.'}, {'measure': 'Rate of Catheter Ablation of Pulmonary Vein Ostia During the Follow-up Period', 'timeFrame': '6, 12, 18, 24, 30, 36 months', 'description': 'To assess the number of catheter ablation procedures of the pulmonary vein ostia performed in patients at each visit throughout the follow-up period.'}, {'measure': 'Complications of Anticoagulant Therapy', 'timeFrame': '6, 12, 18, 24, 30, 36 months', 'description': 'To assess the incidence of major bleeding (including hemorrhagic stroke), moderate bleeding, and minor bleeding in patients at each visit throughout the follow-up period.'}, {'measure': 'Proportion of Patients Who Switched from Antiplatelet Therapy (Acetylsalicylic Acid, Clopidogrel, Ticagrelor) to Oral Anticoagulants During the Follow-up Period', 'timeFrame': '6, 12, 18, 24, 30, 36 months', 'description': 'To assess the proportion of patients who switched from antiplatelet therapy (acetylsalicylic acid, clopidogrel, ticagrelor) to oral anticoagulants at each visit throughout the follow-up period.'}, {'measure': 'Proportion of Patients Who Switched from Oral Anticoagulants to Antiplatelet Therapy (Acetylsalicylic Acid, Clopidogrel, Ticagrelor) During the Follow-up Period', 'timeFrame': '6, 12, 18, 24, 30, 36 months', 'description': 'To assess the proportion of patients who switched from oral anticoagulants to antiplatelet therapy (acetylsalicylic acid, clopidogrel, ticagrelor) at each visit throughout the follow-up period.'}, {'measure': 'Proportion of Patients Who Switched from Warfarin to Direct Oral Anticoagulants During the Follow-up Period', 'timeFrame': '6, 12, 18, 24, 30, 36 months', 'description': 'To assess the proportion of patients who switched from warfarin to direct oral anticoagulants at each visit throughout the follow-up period.'}, {'measure': 'Proportion of Patients Who Switched from Direct Oral Anticoagulants to Warfarin During the Follow-up Period', 'timeFrame': '6, 12, 18, 24, 30, 36 months', 'description': 'To assess the proportion of patients who switched from direct oral anticoagulants to warfarin at each visit throughout the follow-up period.'}, {'measure': 'Hospitalization for Cardiovascular Disease', 'timeFrame': '6, 12, 18, 24, 30, 36 months', 'description': 'To assess the rate of hospitalizations related to cardiovascular disease in patients at each visit throughout the follow-up period.'}, {'measure': 'All-Cause Hospitalization', 'timeFrame': '6, 12, 18, 24, 30, 36 months', 'description': 'To assess the rate of hospitalizations for any cause in patients at each visit throughout the follow-up period.'}, {'measure': 'All-Cause Mortality', 'timeFrame': '6, 12, 18, 24, 30, 36 months', 'description': 'To assess the rate of death from any cause in patients at each visit throughout the follow-up period.'}, {'measure': 'Cardiovascular Mortality', 'timeFrame': '6, 12, 18, 24, 30, 36 months', 'description': 'To assess the rate of death from cardiovascular causes in patients at each visit throughout the follow-up period.'}, {'measure': 'Death from Hemorrhagic Complications, Including Hemorrhagic Stroke', 'timeFrame': '6, 12, 18, 24, 30, 36 months', 'description': 'To assess the rate of death related to hemorrhagic complications (including hemorrhagic stroke) in patients at each visit throughout the follow-up period.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Anticoagulant Therapy', 'Thromboembolic Complications'], 'conditions': ['Atrial Fibrillation (AF)']}, 'descriptionModule': {'briefSummary': 'Multicenter Non-Interventional Real-World Clinical Practice Registry of Patients with Atrial Fibrillation. The primary objective of the registry is an epidemiological assessment of the characteristics, clinical outcomes, and therapeutic approaches in patients with atrial fibrillation and a CHA₂DS₂-VASc score of no more than 2 for men and no more than 3 for women.', 'detailedDescription': 'Multicenter Non-Interventional Real-World Clinical Practice Registry of Patients with Atrial Fibrillation. The primary objective of the registry is an epidemiological assessment of the characteristics, clinical outcomes, and therapeutic approaches in patients with atrial fibrillation and a CHA₂DS₂-VASc score of no more than 2 for men and no more than 3 for women.\n\nThe registry comprises both a retrospective and a prospective component. Patient enrollment in the retrospective part will be conducted through the review of medical records of individuals who were followed up for atrial fibrillation at the participating centers during the preceding three years. For inclusion in the prospective part, screening of all patients meeting the predefined inclusion and non-inclusion criteria will be performed during routine outpatient and inpatient care, followed by prospective follow-up over a three-year period.\n\nData derived from the retrospective and prospective phases of the registry will enable an epidemiological assessment of the demographic and clinical characteristics, outcomes, and therapeutic approaches employed in real-world clinical practice among patients with atrial fibrillation. These findings may provide important insights to advance the understanding of diagnostic and management strategies, and to inform efforts aimed at optimizing healthcare delivery within this patient cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Anonymized male and female patients aged 18 to 64 years suffering from atrial fibrillation confirmed by a specialist, with a CHA₂DS₂-VASc score ranging from 0 to 2 for men and from 1 to 3 for women.', 'healthyVolunteers': False, 'eligibilityCriteria': "Retrospective Part The retrospective part will include patients who attended a physician consultation for atrial fibrillation three years ago and who met the inclusion criteria at that time.\n\nInclusion criteria for the retrospective part:\n\n* Male or female patients aged 18 to 64 years at the time of data registration;\n* Presence of a specialist-confirmed diagnosis of atrial fibrillation;\n* CHA₂DS₂-VASc score ranging from 0 to 2 for men and from 1 to 3 for women.\n\nNon-inclusion criteria for the retrospective part:\n\n* Age under 18 years;\n* Age over 64 years;\n* CHA₂DS₂-VASc score greater than 2 for men and greater than 3 for women;\n* Inability to undergo screening examination and follow-up;\n* Organ or tissue transplantation less than 5 years prior to study enrollment;\n* Open heart surgery (coronary artery bypass grafting, valve replacement, reconstructive aortic surgery) within 6 months prior to study enrollment;\n* Established diagnosis of dementia of any severity and/or established diagnosis of moderate or severe encephalopathy, as well as other conditions precluding independent regular medication intake.\n\nProspective Part\n\nInclusion criteria for the prospective part:\n\n* Male or female patients aged 18 to 64 years at the time of data registration;\n* Presence of a specialist-confirmed diagnosis of atrial fibrillation;\n* CHA₂DS₂-VASc score ranging from 0 to 2 for men and from 1 to 3 for women at the time of screening.\n\nNon-inclusion criteria for the prospective part:\n\n* Age under 18 years;\n* Age over 64 years;\n* CHA₂DS₂-VASc score greater than 2 for men and greater than 3 for women;\n* Inability to undergo screening examination and follow-up;\n* Organ or tissue transplantation less than 5 years prior to study enrollment;\n* Open heart surgery (coronary artery bypass grafting, valve replacement, reconstructive aortic surgery) within 6 months prior to study enrollment;\n* Established diagnosis of dementia of any severity and/or established diagnosis of moderate or severe encephalopathy, as well as other conditions precluding independent regular medication intake.\n\nExclusion criteria:\n\n* Patient withdrawal of consent for further participation in the study;\n* Identification of factors precluding further patient participation in the study (at the physician's discretion)."}, 'identificationModule': {'nctId': 'NCT07437456', 'acronym': 'AF-CARD', 'briefTitle': 'AF-CARD Registry (Real-World Clinical Practice Registry of Patients With Atrial Fibrillation)', 'organization': {'class': 'OTHER', 'fullName': 'Eurasian Association of Therapists'}, 'officialTitle': 'AF-CARD Registry (Real-World Clinical Practice Registry of Patients With Atrial Fibrillation)', 'orgStudyIdInfo': {'id': 'AF-CARD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retrospective branch', 'description': 'The retrospective cohort will include patients who attended a physician consultation for atrial fibrillation three years ago and who met the study inclusion criteria at the time of that visit.'}, {'label': 'Prospective branch', 'description': 'All patients aged 18 to 64 years at the time of data registration, with a specialist-confirmed diagnosis of atrial fibrillation and a CHA₂DS₂-VASc score ranging from 0 to 2 for men and from 1 to 3 for women at the time of screening.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'country': 'Russia', 'contacts': [{'name': 'Alexander Vaskin', 'role': 'CONTACT', 'email': 'avaskin@euat.ru', 'phone': '+7 495 708-42-23'}], 'facility': 'Eurasian Association of Therapists', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Dmitrii Evdokimov, PhD', 'role': 'CONTACT', 'email': 'd.evdokimov@euat.ru', 'phone': '+79112510942'}, {'name': 'Alexander Vaskin', 'role': 'CONTACT', 'email': 'avaskin@euat.ru', 'phone': '+7 495 708-42-23'}], 'overallOfficials': [{'name': 'Alexander Arutyunov, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Eurasian Association of Therapists'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eurasian Association of Therapists', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}