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Atrial FibrillationCardioCHUVI-AFNCT04364516

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

An observational study of Atrial Fibrillation, run by Hospital Álvaro Cunqueiro at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Atrial Fibrillation
What is being tested?
Anticoagulation
Type of treatment
Pill or oral medicine
How many people
15,000 participants
Where
1 siteSpain
Study dates
26 Nov 2018to 26 Nov 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All patients with atrial fibrillation from Health Area of Vigo

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

SONIA BLANCO PRIETO, PhD contact

620170387

raposeiras26@hotmail.com

Spain1 site, 1 recruiting

  • Department of Cardiology, Hospital Álvaro Cunqueiro

    Vigo, Pontevedra, 36312

    ANDRES IÑIGUEZ ROMO, MD, PhD, andres.iniguez.romo@sergas.es

    SERGIO RAPOSEIRAS ROUBIN, MD, PhD

    Recruiting

Other trials in Spain

About this study

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)

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.

Read the 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.

Being tested
Anticoagulation
Keywords
Atrial Fibrllation; Anticoagulation; Bleeding; Embolism.
Medical subject headings
Atrial Fibrillation, Hemorrhage, Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AnticoagulationDrug

    Also called Vitamin K Antagonists or Direct Oral Anticoagulants

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    All cause Mortality

    Measured: Follow-up (3 years)

Secondary outcomes (2)

  1. Bleeding

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

    Measured: Follow-up (3 years)

  2. 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.

    Measured: Follow-up (3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2020
  2. Study start26 Nov 2018
  3. Primary completion26 Nov 2022 (estimated)
  4. Study completion26 Nov 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
15,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04364516
Sponsor's protocol ID
HAC-ACO-2018-01
Acronym
CardioCHUVI-AF
Status last verified
Apr 2020
First submitted
24 Apr 2020
Last updated
28 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data of CardioCHUVI-AF registry could be merge with other registries, always they have similar characteristics, with a same registry nature

Publications

  • 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.

    PubMed 38579940

  • 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.

    PubMed 36175253

  • 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.

    PubMed 35279417

  • 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.

    PubMed 33607060

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Hospital Álvaro Cunqueiro at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact SONIA BLANCO PRIETO, PhD (620170387, raposeiras26@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: Follow-up (3 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04364516, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.

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