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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01317602

Acronym

MANAGE-AF

Enrollment

603

Registered

2011-03-17

Start date

2011-03-31

Completion date

Unknown

Last updated

2015-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation, AF

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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).
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.

Countries

Greece

Outcome results