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

April 24, 2020 updated by: Hospital Álvaro Cunqueiro

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36312
        • Recruiting
        • Department of Cardiology, Hospital Álvaro Cunqueiro
        • Contact:
        • Principal Investigator:
          • SERGIO RAPOSEIRAS ROUBIN, MD, PhD
        • Sub-Investigator:
          • EMAD ABU ASSI, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with atrial fibrillation from Health Area of Vigo

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Follow-up (3 years)
All cause Mortality
Follow-up (3 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding
Time Frame: Follow-up (3 years)
Bleeding according to International Society on Thrombosis and Haemostasis(ISTH) classiffication
Follow-up (3 years)
Embolism
Time Frame: 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.
Follow-up (3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Álvaro Cunqueiro

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2018

Primary Completion (Anticipated)

November 26, 2022

Study Completion (Anticipated)

November 26, 2023

Study Registration Dates

First Submitted

April 24, 2020

First Submitted That Met QC Criteria

April 24, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 24, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAC-ACO-2018-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data of CardioCHUVI-AF registry could be merge with other registries, always they have similar characteristics, with a same registry nature

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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