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

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT01317602
• Lead Sponsor: Hellenic Cardiovascular Research Society

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-16
• Study First Submitted QC: 2011-03-16
• Study First Posted: 2011-03-17
• Primary Completion: 2011-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-15
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 603

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the management of patients with Atrial Fibrillation.	1 year	Evaluation of the use of anticoagulants and antithrombotic drugs. Evaluation of the doctors' compliance with the guidelines.

Secondary Outcome Measures

Name	Time	Method
Assessment of morbidity and mortality of patients with AF.	1 year	Assessment of morbidity and mortality of patients with AFduring one year follow-up in comparison with previous results from other registries.
Assessment of the compliance of patients to treatment.	Baseline-6months-12months	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).
Evaluation of the risk of strokes.	Baseline-6month-12months	Evaluation of the risk in a large number of patients using the CHA2DS2-VASc and HAS-BLED scores.
Assessment of the awareness of patients about the Atrial Fibrillation.	Baseline	Assessment of the awareness of patients about the Atrial Fibrilation and the potential risk of AF.
Assessment of patients' quality of life.	Baseline-6months-12months	Assessment of patients' quality of life (QoL) using a specific questionnaire (EQ - 5D, http://www.euroqol.org) and EHRA score for evaluation of symptoms.

Trial Locations

Locations (27)

7th IKA Hospital of Athens; 🇬🇷 Athens, Greece

General Hospital Of Heraklio Venizeleio; 🇬🇷 Heraklio, Greece

Alexandra Hospital; 🇬🇷 Athens, Greece

General Hospital of Serres; 🇬🇷 Serres, Greece

Euroclinic Athens; 🇬🇷 Athens, Greece

General Hospital of Athens Evangelismos; 🇬🇷 Athens, Greece

Sismanoglio General Hospital; 🇬🇷 Athens, Greece

Thriassio General Hospital of Elefsina; 🇬🇷 Elefsina, Greece

University Hospital of Heraklion; 🇬🇷 Heraklion, Greece

Agios Loukas Clinic; 🇬🇷 Thessaloniki, Greece

University Hospital of Thessaloniki AXEPA; 🇬🇷 Thessaloniki, Greece

General Hospital of Volos; 🇬🇷 Volos, Greece

Ippokrateio Hospital of Thessaloniki; 🇬🇷 Thessaloniki, Greece

KAT General Hospital; 🇬🇷 Athens, Greece

General Hospital of Chalkida; 🇬🇷 Chalkida, Greece

University Hospital of Alexandroupoli; 🇬🇷 Alexandroupoli, Greece

Laiko General Hospital; 🇬🇷 Athens, Greece

Ygeia Hospital; 🇬🇷 Athens, Greece

General Hospital of Edessa; 🇬🇷 Edessa, Greece

General Hospital of Komotini Sismanoglio; 🇬🇷 Komotini, Greece

2nd IKA Hospital of Thessaloniki; 🇬🇷 Thessaloniki, Greece

Henry Dunant Hospital; 🇬🇷 Athens, Greece

Korgialenio Benakio EES Hospital; 🇬🇷 Athens, Greece

General Hospital of Kavala; 🇬🇷 Kavala, Greece

General Hospital of Chania; 🇬🇷 Chania, Greece

General Hospital of Chios; 🇬🇷 Chios, Greece

General Hospital of Ptolemaida Mpodosakeio; 🇬🇷 Ptolemaida, Greece