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

Atrial Fibrillation Clinical Trial

— CardioCHUVI-AF  

Official title:

Retrospective Observational Registry of Patients With Atrial Fibrillation From Vigo´s Health Area (Registro Observacional Retrospectivo de Pacientes Con Fibrilación Auricular Del Área de Vigo)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04364516
• Other study ID #: HAC-ACO-2018-01
• Status: Recruiting
• Start date: November 26, 2018
• Est. completion date: November 26, 2023

Study information

• Verified date: April 2020
• Source: Hospital Álvaro Cunqueiro
• Contact: SONIA BLANCO PRIETO, PhD
• Phone: 620170387
• Email: raposeiras26[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: November 26, 2023
• Est. primary completion date: November 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Anticoagulation
Study of prognostic impact according to oral anticoagulation therapy (Vitamin K Antagonists or Direct Oral Anticoagulants)

Locations

Country	Name	City	State
Spain	Department of Cardiology, Hospital Álvaro Cunqueiro	Vigo	Pontevedra

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Álvaro Cunqueiro

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	All cause Mortality	Follow-up (3 years)
Secondary	Bleeding	Bleeding according to International Society on Thrombosis and Haemostasis(ISTH) classiffication	Follow-up (3 years)
Secondary	Embolism	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.	Follow-up (3 years)