Systematic Screening With Electrocardiogram for Unknown A... | NCT02892578

Studies
Systematic Screening With Electrocardiogram for Unknown Atrial Fibrillation in 65 Years Old and Above People in Nursing Home

NCT02892578

Sponsor

University Hospital, Montpellier

Status

Terminated

Last Update Posted

Apr 13, 2020Actual

Enrollment

287Actual

Phase

Not Applicable

Conditions

Atrial Fibrillation

Interventions

electrocardiogram

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The Study halted prematurely because the potential for recruitment into the associated center was reached.

Expanded Access Info

Start Date

Jul 22, 2015Actual

Primary Completion Date

May 25, 2016Actual

Completion Date

May 25, 2016Actual

First Submitted Date

Sep 2, 2016

First Submission Date that Met QC Criteria

Sep 7, 2016

First Posted Date

Sep 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2020

Last Update Posted Date

Apr 13, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

287Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
electrocardiogram	Experimental	Patient will take an electrocardiogram in order to detect atrial fibrillation	Other: electrocardiogram

Interventions

Name	Type	Description	Arm Group Labels	Other Names
electrocardiogram	Other		electrocardiogram

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
presence of atrial fibrillation on electrocardiogram	detection of atrial fibrillation during the electrocardiogram	up to 1 hour

Secondary Outcomes

Measure	Description	Time Frame
presence of irregular pulse		up to 1 hour

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

100 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Heart and vascular diseases service		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided