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The European Registry of Older Subjects With Atrial Fibrillation (EUROSAF) (EUROSAF)

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ClinicalTrials.gov Identifier: NCT02973984
Recruitment Status : Recruiting
First Posted : November 28, 2016
Last Update Posted : August 3, 2018
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Alberto Pilotto, Ente Ospedaliero Ospedali Galliera

Study Description
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Brief Summary:

Preliminary data suggest that:

  1. a different risk of mortality, as assessed by the Multidimensional Prognostic Indices (MPI), may influence the anticoagulant prescription in older subjects with Atrial Fibrillation (AF);
  2. the presence of multidimensional impairment, disability and multi-morbidities are usually not included in the decision algorithm of the more appropriate treatments in older patients with AF;
  3. considering the prognostic information, as calculated by the MPI, can be useful to physicians in identifying older patients with AF that can benefit from anticoagulant treatment in term of increased survival.

Condition or disease
Atrial Fibrillation

Detailed Description:

The main objective of this observational study is to evaluate in a "real world" population of older hospitalized patients with AF, the clinical benefit/risk ratio of the anticoagulant treatments in terms of:

  1. mortality (all-cause and vascular mortality);
  2. thromboembolic events, i.e. stroke, systemic embolism;
  3. bleeding side-effects, especially intracranial and gastrointestinal bleeding Secondary objective of the study is to evaluate whether a different prognostic profile, as determined by the MPI, is associated with 1) different kind of treatments for AF (no treatment vs anticoagulants, i.e. Vitamin K Antagonists (VKA) or novel oral anticoagulant (NOACs); and 2) differences in the main outcomes (i.e. mortality, major thromboembolic events and side effects including bleeding events).

Study Design
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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating the Efficacy and Risks of Anticoagulant Treatments in Multimorbid Frail Older Subjects With Atrial Fibrillation. The European Registry of Older Subjects With Atrial Fibrillation (EUROSAF)
Study Start Date : November 18, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. all-cause mortality and vascular mortality [ Time Frame: 12 months ]
    Vascular mortality is defined as: stroke, embolism, myocardial infarction

  2. thromboembolic events, [ Time Frame: 12 months ]
    stroke and/or systemic embolism

  3. bleeding side-effects [ Time Frame: 12 months ]
    major intracranial and gastrointestinal bleeding.


Secondary Outcome Measures :
  1. vascular-related hospitalization rates [ Time Frame: 12 months ]
    stroke and/or systemic embolism

  2. bleeding-related hospitalization rates [ Time Frame: 12 months ]
    intracranial and gastrointestinal bleeding

  3. MPI value and different mortality risk class [ Time Frame: 12 months ]
    mild, moderate, severe

  4. presence/absence of anticoagulant treatments [ Time Frame: 12 months ]
    presence of anticoagulant treatments


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This is a cross-national, prospective, observational study that will include about 3.000 older subjects (aged ≥ 65 years) with AF hospitalized in 30 European geriatric centers (about 100 subjects/center) for an acute disease or a relapse of a chronic diseases. The study is in the frame of the Special Interest Group on CGA (Comprehensive Geriatric Assessment) of the EUGMS (European Union Geriatric Medicine Society).
Criteria

Inclusion Criteria:

This is an observational study in which all consecutive patients admitted to the Geriatrics Units involved in the project will be screened for inclusion. The inclusion criteria are:

  1. patients of both genders, aged 65 years and older
  2. admitted to hospital for acute diseases or a relapse of chronic diseases
  3. with a documented diagnosis of non valvular AF
  4. who are willing to participate in the survey and give their informed consent

Exclusion Criteria:

  1. age less than 65 years
  2. patients who have not provided informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02973984


Contacts
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Contact: Alberto Pilotto, MD 0039 010 563 ext 4467 alberto.pilotto@galliera.it
Contact: Alessandra Argusti, PDH 0039 010 563 ext 4188 a.argusti@galliera.it

Locations
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Italy
S.C. Geriatria Recruiting
Genova, Italy, 16128
Contact: Alberto Pilotto, MD    0039 010 536 ext 4467    alberto.pilotto@galliera.it   
Sponsors and Collaborators
Alberto Pilotto
Bayer
Investigators
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Principal Investigator: Alberto Pilotto, MD Dipartimento: area delle cure geriatriche, ortogeriatria e riabilitazione - E.O. Ospedali Galliera - Genova Italy
More Information
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Additional Information:
software for Windows to calculate the MPI.  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: Alberto Pilotto, Director of Department Geriatric Care, OrthoGeriatrics and Rehabilitation, Ente Ospedaliero Ospedali Galliera
ClinicalTrials.gov Identifier: NCT02973984     History of Changes
Other Study ID Numbers: 28UCS2015
162REG2016 ( Other Identifier: Ethics Commitee of the Liguria Region )
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Alberto Pilotto, Ente Ospedaliero Ospedali Galliera:
Anticoagulant Treatments
Multidimensional Prognostic Index (MPI)
Comprehensive Geriatric Assessment (CGA)
 Frailty
Elderly
Atrial Fibrillation

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