Current Clinical Practice in the Management of Atrial Fibrillation in Greece: the MANAGE-AF Study

Atrial Fibrillation Clinical Trial

— MANAGE-AF  

Official title:

Current Clinical Practice in the Management of Atrial Fibrillation in Greece: the MANAGE-AF Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01317602
• Other study ID #: HellenicCardiovascularRS
• Status: Completed
• Phase: N/A
• First received: March 16, 2011
• Last updated: April 15, 2015
• Start date: March 2011

Study information

• Verified date: April 2015
• Source: Hellenic Cardiovascular Research Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial Summary

This is a multicenter, 1-year prospective, observational study of Atrial Fibrillation (AF) in Greece, designed to provide real world data regarding the characteristics of AF patients in Greece, as well as current clinical practices and adherence to the 2010 ESC guidelines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 603
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients aged = 18 years with any type of AF(first diagnosed, paroxysmal, persistent, long-standing persistent and permanent) according to the classification described in the recent ESC guidelines.

2. All patients should give written informed consent to participate in the study.

Exclusion Criteria:

1. Patients anticipated life expectancy less than 1 year due to a severe concomitant disease.

2. Participation in an another clinical trial, with the exception of epidemiology trials (observational) that do not influence AF management.

3. Patients with mental disability unable to comply with follow - up visits and these who are unable to provide, in written, their informed consent or patients with anticipated inability to adhere to scheduled follow up visits.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Greece	University Hospital of Alexandroupoli	Alexandroupoli
Greece	7th IKA Hospital of Athens	Athens
Greece	Alexandra Hospital	Athens
Greece	Euroclinic Athens	Athens
Greece	General Hospital of Athens Evangelismos	Athens
Greece	Henry Dunant Hospital	Athens
Greece	KAT General Hospital	Athens
Greece	Korgialenio Benakio EES Hospital	Athens
Greece	Laiko General Hospital	Athens
Greece	Sismanoglio General Hospital	Athens
Greece	Ygeia Hospital	Athens
Greece	General Hospital of Chalkida	Chalkida
Greece	General Hospital of Chania	Chania
Greece	General Hospital of Chios	Chios
Greece	General Hospital of Edessa	Edessa
Greece	Thriassio General Hospital of Elefsina	Elefsina
Greece	General Hospital Of Heraklio Venizeleio	Heraklio
Greece	University Hospital of Heraklion	Heraklion
Greece	General Hospital of Kavala	Kavala
Greece	General Hospital of Komotini Sismanoglio	Komotini
Greece	General Hospital of Ptolemaida Mpodosakeio	Ptolemaida
Greece	General Hospital of Serres	Serres
Greece	2nd IKA Hospital of Thessaloniki	Thessaloniki
Greece	Agios Loukas Clinic	Thessaloniki
Greece	Ippokrateio Hospital of Thessaloniki	Thessaloniki
Greece	University Hospital of Thessaloniki AXEPA	Thessaloniki
Greece	General Hospital of Volos	Volos

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Cardiovascular Research Society	Bayer

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the management of patients with Atrial Fibrillation.	Evaluation of the use of anticoagulants and antithrombotic drugs. Evaluation of the doctors' compliance with the guidelines.	1 year	No
Secondary	Evaluation of the risk of strokes.	Evaluation of the risk in a large number of patients using the CHA2DS2-VASc and HAS-BLED scores.	Baseline-6month-12months	No
Secondary	Assessment of morbidity and mortality of patients with AF.	Assessment of morbidity and mortality of patients with AFduring one year follow-up in comparison with previous results from other registries.	1 year	No
Secondary	Assessment of the compliance of patients to treatment.	Evaluation of the compliance of patients to treatment and the frequency of visits to their physician especially in terms of achieving therapeutic target INR (TTR, Time in Therapeutic Range).	Baseline-6months-12months	No
Secondary	Assessment of the awareness of patients about the Atrial Fibrillation.	Assessment of the awareness of patients about the Atrial Fibrilation and the potential risk of AF.	Baseline	No
Secondary	Assessment of patients' quality of life.	Assessment of patients' quality of life (QoL) using a specific questionnaire (EQ - 5D, http://www.euroqol.org) and EHRA score for evaluation of symptoms.	Baseline-6months-12months	No