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Completed

NCT Number: NCT02910856

Infective Endocarditis in the Elderly

ELDERL-IE is a multicenter national prospective observational study.

The main objective is to describe geriatric characteristics (comorbidities, cognitive status, autonomy, nutritional status, balance and walking) in patients aged 75 years or older with infective endocarditis (IE).

The secondary objectives are to assess the impact of geriatric features on the medico - surgical care and on morbidity and mortality at 3 months after the end of the hospitalization, and to describe the initial clinical presentation and diagnostic modalities in the IE elderly.

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Key information

Conditions

Infective Endocarditis Cardiovascular Diseases Endocarditis Heart Diseases

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Central Hospital - University Hospital

Nancy, 54000, France

About this study

Population monitoring:

Clinical, therapeutic, biological, microbiological, echocardiographic and geriatric data are collected. (M-2/3 before inclusion; D-15 before inclusion; D0; M3; vital status at 1 year)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all patients older than 75 years are eligible if they are considered and treated as a case of IE by physicians ensuring their medical care.
  • the patient should be treated in one of the clinical sites participating at the study.
  • the patient should benefit during initial hospitalization of a geriatric assessment, in addition to the usual clinical and therapeutic management of such patients.

Exclusion criteria

  • patients not fulfilling the criteria of definite or possible endocarditis according to Duke modified by Li diagnostic classification that will be applied after collection of all the data at the discharge of the patient.

Treatment and study plan

Primary outcomes

  1. Change from baseline geriatric characteristics at 3 months

    Time frame: 3 months after inclusion

    OMS score

Secondary outcomes

  1. Three months mortality

    Time frame: 3 months after inclusion

    Mortality rate at 3 months

  2. One year mortality

    Time frame: 1 year after inclusion

    Mortality rate at 1 year

  3. Change from baseline geriatric characteristics at 3 months

    Time frame: 3 months after inclusion

    Karnofsky'score

  4. Change from baseline geriatric characteristics at 3 months

    Time frame: 3 months after inclusion

    Score MNA

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Collaborators

  • Fondation Cœur et Recherche

Registry information

Official study title

Infective Endocarditis in the Elderly: Description of the Geriatric Characteristics and Their Influence on Therapeutic Care and the Morbidity and Mortality at 3 Months (ELDERL-IE)

Acronym: ELDERL-IE

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Sep 22, 2016
Registry last updated
Jan 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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