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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Hellenic Cardiovascular Research Society
ClinicalTrials.gov Identifier:
NCT01317602
First received: March 16, 2011
Last updated: April 15, 2015
Last verified: April 2015
  Purpose

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.


Condition
Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Current Clinical Practice in the Management of Atrial Fibrillation in Greece: the MANAGE-AF Study

Resource links provided by NLM:


Further study details as provided by Hellenic Cardiovascular Research Society:

Primary Outcome Measures:
  • Evaluation of the management of patients with Atrial Fibrillation. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Evaluation of the use of anticoagulants and antithrombotic drugs. Evaluation of the doctors' compliance with the guidelines.


Secondary Outcome Measures:
  • Evaluation of the risk of strokes. [ Time Frame: Baseline-6month-12months ] [ Designated as safety issue: No ]
    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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline-6months-12months ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Assessment of the awareness of patients about the Atrial Fibrilation and the potential risk of AF.

  • Assessment of patients' quality of life. [ Time Frame: Baseline-6months-12months ] [ Designated as safety issue: No ]
    Assessment of patients' quality of life (QoL) using a specific questionnaire (EQ - 5D, http://www.euroqol.org) and EHRA score for evaluation of symptoms.


Enrollment: 603
Study Start Date: March 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01317602

Locations
Greece
University Hospital of Alexandroupoli
Alexandroupoli, Greece
Ygeia Hospital
Athens, 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
Laiko General Hospital
Athens, Greece
Sismanoglio General Hospital
Athens, Greece
Korgialenio Benakio EES 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, Greece
Sponsors and Collaborators
Hellenic Cardiovascular Research Society
Bayer
Investigators
Principal Investigator: Panos E. Vardas, MD, FESC, FACC President, Hellenic Cardiovascular Research Society
  More Information

No publications provided

Responsible Party: Hellenic Cardiovascular Research Society
ClinicalTrials.gov Identifier: NCT01317602     History of Changes
Other Study ID Numbers: HellenicCardiovascularRS
Study First Received: March 16, 2011
Last Updated: April 15, 2015
Health Authority: Greece: National Organization of Medicines

Keywords provided by Hellenic Cardiovascular Research Society:
Atrial Fibrillation
AF

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 30, 2015