Predictors of Occult Atrial Fibrillation in 171 Patients... | NCT03166969

Studies
Predictors of Occult Atrial Fibrillation in 171 Patients With Cryptogenic TIA and Minor Stroke

NCT03166969

Sponsor

Versailles Hospital

Status

Completed

Last Update Posted

May 25, 2017Actual

Enrollment

171Actual

Phase

Not Applicable

Conditions

Cryptogenic Transient Ischemic Attack and Minor Stroke

Interventions

Holter 21 days

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

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

Sep 12, 2016

First Submission Date that Met QC Criteria

May 23, 2017

First Posted Date

May 25, 2017Actual

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

May 23, 2017

Last Update Posted Date

May 25, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Retrospective study, single-center, on 171 patients, presented a cryptogenic TIA and Minor stroke.

This study objective is to determine profitability of Holter 21 days for screening paroxystic ACFA / flutter in cryptogenic TIA/Minor stroke, and identify the predictive factors of discovery a paroxystic ACFA on Holter 21 days. Clinical and échocardiographics factors, and brain imaging (scanner and MRI) will be analyzed.

Detailed Description

Not provided

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

171Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients taken care in neurovascular unit	Experimental		Procedure: Holter 21 days

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Holter 21 days	Procedure		Patients taken care in neurovascular unit

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of atrial fibrillation detected on long duration ( 21 days) cardiac rythm holter monitoring	Atrial fibrillation >= 30 secondes	Day 21

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cryptogenic TIA/Minor stroke
Age > 18 years
Medical care in Neuro Vascular Unit of CH Versailles
Holter 21 days performed

Exclusion Criteria:

ACFA history
ECG or telemetry who showed ACFA before the Holter initializing
Carotid Stenosis / symptomatic vertebral
Arterial dissection
Prothrombotic state demonstrated by laboratory tests
Infective endocarditis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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
Centre Hospitalier de Versailles		Le Chesnay		78150	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27495831	Result	Sudacevschi V, Bertrand C, Chadenat ML, Tarnaud C, Pico F. Predictors of Occult Atrial Fibrillation in One Hundred Seventy-One Patients with Cryptogenic Transient Ischemic Attack and Minor Stroke. J Stroke Cerebrovasc Dis. 2016 Nov;25(11):2673-2677. doi: 10.1016/j.jstrokecerebrovasdis.2016.07.014. Epub 2016 Aug 2.