Atrial FibrillationNCT02892578
Systematic Screening With Electrocardiogram for Unknown Atrial Fibrillation in 65 Years Old and Above People in Nursing Home
A study testing electrocardiogram in people with Atrial Fibrillation, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- electrocardiogram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jul 2015to 25 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Being in nursing home since 1 month and above
- Aged > 65 years old
- Subjects agree to participate at this project
Who cannot join
- Antecedent of atrial fibrillation
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- electrocardiogram
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrocardiogramOther
| Study group | Role | What they receive |
|---|---|---|
| electrocardiogram | Experimental | Patient will take an electrocardiogram in order to detect atrial fibrillation Receives: Other: electrocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of atrial fibrillation on electrocardiogram
detection of atrial fibrillation during the electrocardiogram
Measured: up to 1 hour
Secondary outcomes (1)
presence of irregular pulse
Measured: up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start22 Jul 2015
- Primary completion25 May 2016
- Study completion25 May 2016
Why it stopped: The Study halted prematurely because the potential for recruitment into the associated center was reached.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892578
- Sponsor's protocol ID
- 9581
- Status last verified
- Apr 2020
- First submitted
- 2 Sep 2016
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Screening With Electrocardiogram for Unknown Atrial Fibrillation in 65 Years Old and Above People in Nursing Home
- ClinicalTrials.gov ID
- NCT02892578
- Acronym / sponsor ID
- 9581
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Study halted prematurely because the potential for recruitment into the associated center was reached.
- Enrolment
- 287 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 22 Jul 2015 (actual)
- Primary completion
- 25 May 2016 (actual)
- Study completion
- 25 May 2016 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| electrocardiogram | Experimental | Other: electrocardiogramPatient will take an electrocardiogram in order to detect atrial fibrillation |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Being in nursing home since 1 month and above
- Aged > 65 years old
- Subjects agree to participate at this project
Key exclusion criteria (1 listed)
- Antecedent of atrial fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrocardiogram | Other | electrocardiogram |
Primary outcome
presence of atrial fibrillation on electrocardiogram
Time frame: up to 1 hour
detection of atrial fibrillation during the electrocardiogram
1 secondary outcome
presence of irregular pulse
Time frame: up to 1 hour
Results and safety
The study was stopped early (reason given: The Study halted prematurely because the potential for recruitment into the associated center was reached.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrocardiogram in people with Atrial Fibrillation, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The Study halted prematurely because the potential for recruitment into the associated center was reached.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of atrial fibrillation on electrocardiogram (time frame: up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2020; AzTrials last refreshed its copy on 6 Nov 2026.