NCT01317602

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
603

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

6 months

First QC Date

March 16, 2011

Last Update Submit

April 15, 2015

Conditions

Atrial Fibrillation

Keywords

Atrial FibrillationAF

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the management of patients with Atrial Fibrillation.

    Evaluation of the use of anticoagulants and antithrombotic drugs. Evaluation of the doctors' compliance with the guidelines.

    1 year

Secondary Outcomes (5)

  • Evaluation of the risk of strokes.

    Baseline-6month-12months

  • Assessment of morbidity and mortality of patients with AF.

    1 year

  • Assessment of the compliance of patients to treatment.

    Baseline-6months-12months

  • Assessment of the awareness of patients about the Atrial Fibrillation.

    Baseline

  • Assessment of patients' quality of life.

    Baseline-6months-12months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.
  • All patients should give written informed consent to participate in the study.

You may not qualify if:

  • Patients anticipated life expectancy less than 1 year due to a severe concomitant disease.
  • Participation in an another clinical trial, with the exception of epidemiology trials (observational) that do not influence AF management.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

University Hospital of Alexandroupoli

Alexandroupoli, Greece

Location

7th IKA Hospital of Athens

Athens, Greece

Location

Alexandra Hospital

Athens, Greece

Location

Euroclinic Athens

Athens, Greece

Location

General Hospital of Athens Evangelismos

Athens, Greece

Location

Henry Dunant Hospital

Athens, Greece

Location

KAT General Hospital

Athens, Greece

Location

Korgialenio Benakio EES Hospital

Athens, Greece

Location

Laiko General Hospital

Athens, Greece

Location

Sismanoglio General Hospital

Athens, Greece

Location

Ygeia Hospital

Athens, Greece

Location

General Hospital of Chalkida

Chalcis, Greece

Location

General Hospital of Chania

Chania, Greece

Location

General Hospital of Chios

Chios, Greece

Location

General Hospital of Edessa

Edessa, Greece

Location

Thriassio General Hospital of Elefsina

Elefsina, Greece

Location

University Hospital of Heraklion

Heraklion, Greece

Location

General Hospital Of Heraklio Venizeleio

Heraklio, Greece

Location

General Hospital of Kavala

Kavala, Greece

Location

General Hospital of Komotini Sismanoglio

Komotini, Greece

Location

General Hospital of Ptolemaida Mpodosakeio

Ptolemaida, Greece

Location

General Hospital of Serres

Serres, Greece

Location

2nd IKA Hospital of Thessaloniki

Thessaloniki, Greece

Location

Agios Loukas Clinic

Thessaloniki, Greece

Location

Ippokrateio Hospital of Thessaloniki

Thessaloniki, Greece

Location

University Hospital of Thessaloniki AXEPA

Thessaloniki, Greece

Location

General Hospital of Volos

Volos, Greece

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Panos E. Vardas, MD, FESC, FACC

    President, Hellenic Cardiovascular Research Society

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2011

First Posted

March 17, 2011

Study Start

March 1, 2011

Primary Completion

September 1, 2011

Last Updated

April 16, 2015

Record last verified: 2015-04

Locations

GR(27)