AF-CARD Registry (Real-World Clinical Practice Registry of Patients With Atrial Fibrillation)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF). Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
The 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.
Data 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.
Primary outcome measures
- Cumulative incidence of thromboembolic complications [Time frame: 6, 12, 18, 24, 30, 36 month]
Secondary outcome measures (12)
- Number of Atrial Fibrillation Paroxysms During the Follow-up Period [Time frame: 6, 12, 18, 24, 30, 36 month]
- Rate of Hospitalizations Due to Atrial Fibrillation Paroxysm During the Follow-up Period [Time frame: 6, 12, 18, 24, 30, 36 months]
- Rate of Catheter Ablation of Pulmonary Vein Ostia During the Follow-up Period [Time frame: 6, 12, 18, 24, 30, 36 months]
- Complications of Anticoagulant Therapy [Time frame: 6, 12, 18, 24, 30, 36 months]
- Proportion of Patients Who Switched from Antiplatelet Therapy (Acetylsalicylic Acid, Clopidogrel, Ticagrelor) to Oral Anticoagulants During the Follow-up Period [Time frame: 6, 12, 18, 24, 30, 36 months]
- Proportion of Patients Who Switched from Oral Anticoagulants to Antiplatelet Therapy (Acetylsalicylic Acid, Clopidogrel, Ticagrelor) During the Follow-up Period [Time frame: 6, 12, 18, 24, 30, 36 months]
- Proportion of Patients Who Switched from Warfarin to Direct Oral Anticoagulants During the Follow-up Period [Time frame: 6, 12, 18, 24, 30, 36 months]
- Proportion of Patients Who Switched from Direct Oral Anticoagulants to Warfarin During the Follow-up Period [Time frame: 6, 12, 18, 24, 30, 36 months]
- Hospitalization for Cardiovascular Disease [Time frame: 6, 12, 18, 24, 30, 36 months]
- All-Cause Hospitalization [Time frame: 6, 12, 18, 24, 30, 36 months]
- All-Cause Mortality [Time frame: 6, 12, 18, 24, 30, 36 months]
- Cardiovascular Mortality [Time frame: 6, 12, 18, 24, 30, 36 months]
Eligibility criteria
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.
Inclusion criteria for the retrospective part:
- Male or female patients aged 18 to 64 years at the time of data registration;
- Presence of a specialist-confirmed diagnosis of atrial fibrillation;
- CHA₂DS₂-VASc score ranging from 0 to 2 for men and from 1 to 3 for women.
Non-inclusion criteria for the retrospective part:
- Age under 18 years;
- Age over 64 years;
- CHA₂DS₂-VASc score greater than 2 for men and greater than 3 for women;
- Inability to undergo screening examination and follow-up;
- Organ or tissue transplantation less than 5 years prior to study enrollment;
- Open heart surgery (coronary artery bypass grafting, valve replacement, reconstructive aortic surgery) within 6 months prior to study enrollment;
- 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.
Prospective Part
Inclusion criteria for the prospective part:
- Male or female patients aged 18 to 64 years at the time of data registration;
- Presence of a specialist-confirmed diagnosis of atrial fibrillation;
- CHA₂DS₂-VASc score ranging from 0 to 2 for men and from 1 to 3 for women at the time of screening.
Non-inclusion criteria for the prospective part:
- Age under 18 years;
- Age over 64 years;
- CHA₂DS₂-VASc score greater than 2 for men and greater than 3 for women;
- Inability to undergo screening examination and follow-up;
- Organ or tissue transplantation less than 5 years prior to study enrollment;
- Open heart surgery (coronary artery bypass grafting, valve replacement, reconstructive aortic surgery) within 6 months prior to study enrollment;
- 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.
Exclusion criteria
- Patient withdrawal of consent for further participation in the study;
- Identification of factors precluding further patient participation in the study (at the physician's discretion).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Russia · 1 center
- Eurasian Association of Therapists — Moscow
Identifiers
NCT: NCT07437456 · AF-CARD