CardioCHUVI-AF: Retrospective Observational Registry of Patients With Atrial Fibrillation From Vigo´s Health Area

Sponsor
Hospital Álvaro Cunqueiro (Other)
Overall Status
Recruiting
CT.gov ID
NCT04364516
Collaborator
(none)
15,000
1
60
250

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Anticipated Enrollment :
15000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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)
Actual Study Start Date :
Nov 26, 2018
Anticipated Primary Completion Date :
Nov 26, 2022
Anticipated Study Completion Date :
Nov 26, 2023

Outcome Measures

Primary Outcome Measures

  1. Mortality [Follow-up (3 years)]

    All cause Mortality

Secondary Outcome Measures

  1. Bleeding [Follow-up (3 years)]

    Bleeding according to International Society on Thrombosis and Haemostasis(ISTH) classiffication

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All patients with confirmed diagnoses of atrial fibrillation by ECG.
Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Cardiology, Hospital Álvaro Cunqueiro Vigo Pontevedra Spain 36312

Sponsors and Collaborators

  • Hospital Álvaro Cunqueiro

Investigators

  • Study Director: EMAD ABU ASSI, PhD, MD, University Hospital Alvaro Cunqueiro, Vigo, Spain
  • Principal Investigator: SERGIO RAPOSEIRAS ROUBIN, PhD, MD, University Hospital Alvaro Cunqueiro, Vigo, Spain
  • Study Chair: ANDRES IÑIGUEZ ROMO, PhD, MD, University Hospital Alvaro Cunqueiro, Vigo, Spain

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospital Álvaro Cunqueiro
ClinicalTrials.gov Identifier:
NCT04364516
Other Study ID Numbers:
  • HAC-ACO-2018-01
First Posted:
Apr 28, 2020
Last Update Posted:
Apr 28, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospital Álvaro Cunqueiro
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2020