Back to resultsSystematic Screening With Electrocardiogram for Unknown Atrial Fibrillation in 65 Years Old and Above People in Nursing Home
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
electrocardiogram
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation
Eligibility Criteria
Inclusion criteria :
- Being in nursing home since 1 month and above
- Aged > 65 years old
- Subjects agree to participate at this project
Exclusion criteria :
- Antecedent of atrial fibrillation
Sites / Locations
- Heart and vascular diseases service
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
electrocardiogram
Arm Description
Patient will take an electrocardiogram in order to detect atrial fibrillation
Outcomes
Primary Outcome Measures
presence of atrial fibrillation on electrocardiogram
detection of atrial fibrillation during the electrocardiogram
Secondary Outcome Measures
presence of irregular pulse
Full Information
NCT ID
NCT02892578
First Posted
September 2, 2016
Last Updated
April 9, 2020
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02892578
Brief Title
Systematic Screening With Electrocardiogram for Unknown Atrial Fibrillation in 65 Years Old and Above People in Nursing Home
Official Title
Systematic Screening With Electrocardiogram for Unknown Atrial Fibrillation in 65 Years Old and Above People in Nursing Home
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
The Study halted prematurely because the potential for recruitment into the associated center was reached.
Study Start Date
July 22, 2015 (Actual)
Primary Completion Date
May 25, 2016 (Actual)
Study Completion Date
May 25, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Atrial fibrillation is the most common arrhythmia. Some studies shown that systematic screening with electrocardiogram could improve atrial fibrillation detection. No studies are available in nursing home. The goal of this study is to screen atrial fibrillation in patients who live in nursing home.
Detailed Description
A prospective observational cross sectional multicenter study.
The goal of this study is to detect atrial fibrillation in nursing home people aged 65 years old and above, with systematic electrocardiogram. Participants agreement will be collected. Participants characteristics data will be collected in all nursing home. For all participants, one visit were realised with electrocardiogram, and symptoms survey. Data were anonymised on each center before analysed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
287 (Actual)
8. Arms, Groups, and Interventions
Arm Title
electrocardiogram
Arm Type
Experimental
Arm Description
Patient will take an electrocardiogram in order to detect atrial fibrillation
Intervention Type
Other
Intervention Name(s)
electrocardiogram
Primary Outcome Measure Information:
Title
presence of atrial fibrillation on electrocardiogram
Description
detection of atrial fibrillation during the electrocardiogram
Time Frame
up to 1 hour
Secondary Outcome Measure Information:
Title
presence of irregular pulse
Time Frame
up to 1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria :
Being in nursing home since 1 month and above
Aged > 65 years old
Subjects agree to participate at this project
Exclusion criteria :
Antecedent of atrial fibrillation
Facility Information:
Facility Name
Heart and vascular diseases service
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Systematic Screening With Electrocardiogram for Unknown Atrial Fibrillation in 65 Years Old and Above People in Nursing Home
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