Clinical trial NCT01317602: Current Clinical Practice in the Management of Atrial Fibrillation in Greece: the MANAGE-AF Study
Official title: Current Clinical Practice in the Management of Atrial Fibrillation in Greece: the MANAGE-AF Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
AF
Lead sponsor: Hellenic Cardiovascular Research Society
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2011-03-17
Enrollment: 603
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The MANAGE-AF study will enroll 600 consecutive patients from the emergency cardiology departments and outpatient clinics in about 35 Greek hospitals. Their selection will be made in an effort to recruit a representative sample of patients from different geographic areas and stratums of the country.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the management of patients with Atrial Fibrillation.
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of the risk of strokes.
timeFrame: Baseline-6month-12months
measure: Assessment of morbidity and mortality of patients with AF.
timeFrame: 1 year
measure: Assessment of the compliance of patients to treatment.
timeFrame: Baseline-6months-12months
measure: Assessment of the awareness of patients about the Atrial Fibrillation.
timeFrame: Baseline
measure: Assessment of patients' quality of life.
timeFrame: Baseline-6months-12months
Other outcomes:
Locations:
city: Alexandroupoli
country: Greece
facility: University Hospital of Alexandroupoli
city: Athens
country: Greece
facility: 7th IKA Hospital of Athens
city: Athens
country: Greece
facility: Alexandra Hospital
city: Athens
country: Greece
facility: Euroclinic Athens
city: Athens
country: Greece
facility: General Hospital of Athens Evangelismos
city: Athens
country: Greece
facility: Henry Dunant Hospital
city: Athens
country: Greece
facility: KAT General Hospital
city: Athens
country: Greece
facility: Korgialenio Benakio EES Hospital
city: Athens
country: Greece
facility: Laiko General Hospital
city: Athens
country: Greece
facility: Sismanoglio General Hospital
city: Athens
country: Greece
facility: Ygeia Hospital
city: Chalkida
country: Greece
facility: General Hospital of Chalkida
city: Chania
country: Greece
facility: General Hospital of Chania
city: Chios
country: Greece
facility: General Hospital of Chios
city: Edessa
country: Greece
facility: General Hospital of Edessa
city: Elefsina
country: Greece
facility: Thriassio General Hospital of Elefsina
city: Heraklion
country: Greece
facility: University Hospital of Heraklion
city: Heraklio
country: Greece
facility: General Hospital Of Heraklio Venizeleio
city: Kavala
country: Greece
facility: General Hospital of Kavala
city: Komotini
country: Greece
facility: General Hospital of Komotini Sismanoglio
city: Ptolemaida
country: Greece
facility: General Hospital of Ptolemaida Mpodosakeio
city: Serres
country: Greece
facility: General Hospital of Serres
city: Thessaloniki
country: Greece
facility: 2nd IKA Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: Agios Loukas Clinic
city: Thessaloniki
country: Greece
facility: Ippokrateio Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: University Hospital of Thessaloniki AXEPA
city: Volos
country: Greece
facility: General Hospital of Volos
Study officials:
affiliation: President, Hellenic Cardiovascular Research Society
name: Panos E. Vardas, MD, FESC, FACC
role: PRINCIPAL_INVESTIGATOR
References: