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Trial record 76 of 123 for:    hypertension "vitamin d"

Risk of Bleeding and Anticoagulation in Atrial Fibrillation: What Predictive Criterion Used? (PREDIC-AGE)

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ClinicalTrials.gov Identifier: NCT02858518
Recruitment Status : Completed
First Posted : August 8, 2016
Last Update Posted : January 23, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief Summary:

Atrial fibrillation (AF) is a rhythmic cardiac activity disorder disturbing hemodynamic blood flow. It is a public health problem with 600,000 to 1 million people involved in France which 2/3 are aged over 75 years. a FA untreated exposes the patient to a significant risk of embolism responsible for a rate stroke (stroke) ischemic estimated at 85%. The anticoagulant standard treatment helps prevent the occurrence of this complication.

However, oral anticoagulation also exposes patients to an increased risk of bleeding. The bleeding risk can be assessed using scales: several being proposed (HEMORR2HAGES, HAS-BLED, ATRIA and scores Shireman and Charlson ...).

moreover, in geriatric hospital care, every patient has a "standardized geriatric assessment" to assess and quantify functional capacity, autonomy, cognitive abilities, nutritional status, psychological state and its environment social.

Thus, the objective of the investigators study was to determine the frequency of each item of each bleeding risk assessment score and geriatric assessment in patients 80 and older hospitalized geriatric ward in the department and with anticoagulant.


Condition or disease Intervention/treatment
Atrial Fibrillation Gerontology Other: questionnaires

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk of Bleeding and Anticoagulation in Atrial Fibrillation: What Predictive Criterion Used?
Study Start Date : March 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
patients with atrial fibrillation with anticoagulant treatment Other: questionnaires
scales : HEMORR2HAGES (hepatics diseases, alcoholism, cancer, thrombocytopenia, anemia and antecedent...), HAS-Bled (arterial hypertension, renal function, liver function, cerebrovascular accident...), ATRIA (anemia, serious kidney diseases, hypertension, antecedent...), Shireman (gender, age, hemorrhage, diabetes, anemia...), Charlson (age, cardiovascular disease, lung disease, neurological disease, endocrinal disease, nephrology, liver disease, gastroenterology, cancer) and standardised geriatric assessment (comorbidities, cognition, mobility, pain, nutrition, living environment...)




Primary Outcome Measures :
  1. scale : HEMORR2HAGES [ Time Frame: at baseline ]
    hepatics diseases, alcoholism, cancer, thrombocytopenia, anemia and antecedent...

  2. scale : HAS-Bled [ Time Frame: at baseline ]
    arterial hypertension, renal function, liver function, cerebrovascular accident...

  3. scale : ATRIA [ Time Frame: at baseline ]
    anemia, serious kidney diseases, hypertension, antecedent...

  4. scale : shireman [ Time Frame: at baseline ]
    gender, age, hemorrhage, diabetes, anemia...

  5. scale charlson [ Time Frame: at baseline ]
    age, cardiovascular disease, lung disease, neurological disease, endocrinal disease, nephrology, liver disease, gastroenterology, cancer

  6. scale : standardised geriatric assessment [ Time Frame: at baseline ]
    comorbidities, cognition, mobility, pain, nutrition, living environment...


Secondary Outcome Measures :
  1. Occurrence of major bleeding event or not major [ Time Frame: at baseline and 6 months ]
  2. genotyping [ Time Frame: at baseline ]
    CYP2C9

  3. genotyping [ Time Frame: at baseline ]
    VKCRC1


Biospecimen Retention:   Samples Without DNA
classical blood sample : NFS, ionograms, CRP, TSH, albumin, vitamin D, Calcium and coagulation factors + tube for genetic study


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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients seniors with atrial fibrillation with anticoagulant treatment
Criteria

Inclusion Criteria:

  • hospitalisation in geriatric unit
  • Atrial fibrillation treated by anticoagulant treatment (AVK or oral anticoagulation)
  • signed inform consent

Exclusion Criteria:

  • estimated lifetime less than 6 months
  • under guardianship or curatorship
  • without support person

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): NCT02858518


Locations
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France
CH de FEURS
Feurs, France, 42110
CH de FIRMINY
Firminy, France, 42700
CH de ROANNE
Roanne, France, 42300
CH de SAINT-CHAMOND
Saint-chamond, France, 42400
CHU de SAINT-ETIENNE
Saint-etienne, France, 42000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Emilie CRAWFORD-ACHOUR, MD CHU de SAINT-ETIENNE

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02858518     History of Changes
Other Study ID Numbers: 1408020
2014-A01664-43 ( Other Identifier: ANSM )
First Posted: August 8, 2016    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
anticoagulant

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