Retrospective Observational Registry of Patients With Atrial Fibrillation From Vigo´s Health Area

• Conditions: Atrial Fibrillation

• Registration Number: NCT04364516
• Lead Sponsor: Hospital Álvaro Cunqueiro

Brief Summary

Registry of all consecutive patients with atrial fibrillation from Heath Area of Vigo, since 2013 to 2020, in order to study therapy, mortality, cardiovascular complications and bleeding events.

Detailed Description

Retrospective observational registry of patients diagnosed of atrial fibrillation between 2013 and 2020. Clinical, analytical and echocardiographic data will be recorded, as well as therapeutic prescription information. Data on mortality and cardioembolic and hemorrhagic events will be collected during follow-up. The aim is to study the prevalence and incidence of atrial fibrillation, the anticoagulant treatment according to cardioembolic risk, the thromboembolic events and hemorrhagic events, the risk of mortality (Cardiovascular, Non-Cardiovascular), the contemporary management (Rhythm control versus frequency control strategy), and other complications, such as heart failure, acute coronary syndrome or cancer.

Study Timeline

• Study Start: 2018-11-26
• Status Verified: 2020-04
• Study First Submitted: 2020-04-24
• Study First Submitted QC: 2020-04-24
• Last Update Submitted: 2020-04-24
• Study First Posted: 2020-04-28
• Last Update Posted: 2020-04-28
• Primary Completion: 2022-11-26
• Study Completion: 2023-11-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15000

Inclusion Criteria

• All patients with confirmed diagnoses of atrial fibrillation by ECG.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	Follow-up (3 years)	All cause Mortality

Secondary Outcome Measures

Name	Time	Method
Bleeding	Follow-up (3 years)	Bleeding according to International Society on Thrombosis and Haemostasis(ISTH) classiffication
Embolism	Follow-up (3 years)	Embolic events include ischemic stroke, transient ischemic attack (TIA), pulmonary embolism (PE), and systemic embolism (SE). Ischemic stroke was defined as sudden onset of a focal deficit consistent with occlusion of a major cerebral artery (documented by means of magnet resonance imaging \[MRI \]or computer tomography \[CT\]) and categorized. TIA was defined as a temporary neurologic deficit presumably due to reduced blood flow in a particular cerebral artery lasting for ≤24 hours with complete resolution of the neurologic deficit. A PE event was confirmed by spiral CT, perfusion-ventilation scan, pulmonary angiography, or autopsy) and resulted in a final PE diagnosis. A SE event was defined as any end-organ ischemia other than in the brain, heart, eyes, and lungs, caused by abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of another likely mechanism.

Trial Locations

Locations (1)

Department of Cardiology, Hospital Álvaro Cunqueiro; 🇪🇸 Vigo, Pontevedra, Spain