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

April 15, 2015 updated by: Hellenic Cardiovascular Research Society
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

603

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Alexandroupoli, Greece
        • University Hospital of Alexandroupoli
      • Athens, Greece
        • Laiko General Hospital
      • Athens, Greece
        • Alexandra Hospital
      • Athens, Greece
        • Sismanoglio General Hospital
      • Athens, Greece
        • 7th IKA Hospital of Athens
      • 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
        • Ygeia Hospital
      • Chalkida, Greece
        • General Hospital of Chalkida
      • Chania, Greece
        • General Hospital of Chania
      • Chios, Greece
        • General Hospital of Chios
      • Edessa, Greece
        • General Hospital of Edessa
      • Elefsina, Greece
        • Thriassio General Hospital of Elefsina
      • Heraklio, Greece
        • General Hospital Of Heraklio Venizeleio
      • Heraklion, Greece
        • University Hospital of Heraklion
      • Kavala, Greece
        • General Hospital of Kavala
      • Komotini, Greece
        • General Hospital of Komotini Sismanoglio
      • Ptolemaida, Greece
        • General Hospital of Ptolemaida Mpodosakeio
      • Serres, Greece
        • General Hospital of Serres
      • Thessaloniki, Greece
        • 2nd IKA Hospital of Thessaloniki
      • Thessaloniki, Greece
        • Agios Loukas Clinic
      • Thessaloniki, Greece
        • Ippokrateio Hospital of Thessaloniki
      • Thessaloniki, Greece
        • University Hospital of Thessaloniki AXEPA
      • Volos, Greece
        • General Hospital of Volos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the management of patients with Atrial Fibrillation.
Time Frame: 1 year
Evaluation of the use of anticoagulants and antithrombotic drugs. Evaluation of the doctors' compliance with the guidelines.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the risk of strokes.
Time Frame: Baseline-6month-12months
Evaluation of the risk in a large number of patients using the CHA2DS2-VASc and HAS-BLED scores.
Baseline-6month-12months
Assessment of morbidity and mortality of patients with AF.
Time Frame: 1 year
Assessment of morbidity and mortality of patients with AFduring one year follow-up in comparison with previous results from other registries.
1 year
Assessment of the compliance of patients to treatment.
Time Frame: 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).
Baseline-6months-12months
Assessment of the awareness of patients about the Atrial Fibrillation.
Time Frame: Baseline
Assessment of the awareness of patients about the Atrial Fibrilation and the potential risk of AF.
Baseline
Assessment of patients' quality of life.
Time Frame: 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.
Baseline-6months-12months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hellenic Cardiovascular Research Society

Collaborators

Bayer

Investigators

  • Principal Investigator: Panos E. Vardas, MD, FESC, FACC, President, Hellenic Cardiovascular Research Society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

March 16, 2011

First Submitted That Met QC Criteria

March 16, 2011

First Posted (Estimate)

March 17, 2011

Study Record Updates

Last Update Posted (Estimate)

April 16, 2015

Last Update Submitted That Met QC Criteria

April 15, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HellenicCardiovascularRS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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