NCT04364516

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 26, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2023

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

4 years

First QC Date

April 24, 2020

Last Update Submit

April 24, 2020

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrllation; Anticoagulation; Bleeding; Embolism.

Outcome Measures

Primary Outcomes (1)

  • Mortality

    All cause Mortality

    Follow-up (3 years)

Secondary Outcomes (2)

  • Bleeding

    Follow-up (3 years)

  • Embolism

    Follow-up (3 years)

Interventions

AnticoagulationDRUG

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

Also known as: Vitamin K Antagonists or Direct Oral Anticoagulants

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with atrial fibrillation from Health Area of Vigo

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Hospital Álvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

RECRUITING

Related Publications (4)

  • Abu-Assi E, Lizancos Castro A, Cespon-Fernandez M, Gonzalez-Bermudez I, Raposeiras Roubin S. Relative performance evaluation of four bleeding risk scores in atrial fibrillation patients. What does the new DOAC score provide? Int J Cardiol. 2024 Jul 15;407:132018. doi: 10.1016/j.ijcard.2024.132018. Epub 2024 Apr 3.

    PMID: 38579940DERIVED

  • Dominguez-Erquicia P, Raposeiras-Roubin S, Abu-Assi E, Bouzon-Iglesias P, Parada-Barcia JA, Lizancos-Castro A, Gonzalez-Garcia A, Noriega-Caro VA, Ledo-Pineiro A, Iglesias-Otero C, Gonzalez-Bermudez I, Iniguez-Romo A. Comparison of Outcomes in Patients With Atrial Fibrillation Under Oral Anticoagulation Therapy Analyzed by Body Weight (<60, 60 to 100, and >100 kg). Am J Cardiol. 2022 Dec 1;184:41-47. doi: 10.1016/j.amjcard.2022.07.028. Epub 2022 Sep 27.

    PMID: 36175253DERIVED

  • Raposeiras-Roubin S, Abu-Assi E, Lizancos Castro A, Barreiro Pardal C, Melendo Viu M, Cespon Fernandez M, Blanco Prieto S, Rossello X, Ibanez B, Filgueiras-Rama D, Iniguez Romo A. Nutrition status, obesity and outcomes in patients with atrial fibrillation. Rev Esp Cardiol (Engl Ed). 2022 Oct;75(10):825-832. doi: 10.1016/j.rec.2022.01.006. Epub 2022 Mar 9. English, Spanish.

    PMID: 35279417DERIVED

  • Cespon-Fernandez M, Raposeiras-Roubin S, Abu-Assi E, Melendo-Viu M, Garcia-Campo E, Iniguez-Romo A. Renin-Angiotensin System Inhibitors Prognostic Benefit in Older Patients with Atrial Fibrillation. J Am Med Dir Assoc. 2021 Oct;22(10):2190-2195. doi: 10.1016/j.jamda.2021.01.063. Epub 2021 Feb 16.

    PMID: 33607060DERIVED

MeSH Terms

Conditions

Atrial FibrillationHemorrhageEmbolism

Interventions

N(4)-oleylcytosine arabinoside

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and ThrombosisVascular Diseases

Study Officials

  • EMAD ABU ASSI, PhD, MD

    University Hospital Alvaro Cunqueiro, Vigo, Spain

    STUDY DIRECTOR

  • SERGIO RAPOSEIRAS ROUBIN, PhD, MD

    University Hospital Alvaro Cunqueiro, Vigo, Spain

    PRINCIPAL INVESTIGATOR

  • ANDRES IÑIGUEZ ROMO, PhD, MD

    University Hospital Alvaro Cunqueiro, Vigo, Spain

    STUDY CHAIR

Central Study Contacts

SONIA BLANCO PRIETO, PhD

CONTACT

620170387raposeiras26@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2020

First Posted

April 28, 2020

Study Start

November 26, 2018

Primary Completion

November 26, 2022

Study Completion

November 26, 2023

Last Updated

April 28, 2020

Record last verified: 2020-04

Locations

ES(1)