search
Back to results

Predictors of Occult Atrial Fibrillation in 171 Patients With Cryptogenic TIA and Minor Stroke (HOLTER-21J)

Primary Purpose

Cryptogenic Transient Ischemic Attack and Minor Stroke

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Holter 21 days
Sponsored by
Versailles Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cryptogenic Transient Ischemic Attack and Minor Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. ACFA history
  2. ECG or telemetry who showed ACFA before the Holter initializing
  3. Carotid Stenosis / symptomatic vertebral
  4. Arterial dissection
  5. Prothrombotic state demonstrated by laboratory tests
  6. Infective endocarditis

Sites / Locations

  • Centre Hospitalier de Versailles

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients taken care in neurovascular unit

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 12, 2016
Last Updated
May 23, 2017
Sponsor
Versailles Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03166969
Brief Title
Predictors of Occult Atrial Fibrillation in 171 Patients With Cryptogenic TIA and Minor Stroke
Acronym
HOLTER-21J
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Versailles Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cryptogenic Transient Ischemic Attack and Minor Stroke

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
171 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients taken care in neurovascular unit
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Holter 21 days
Primary Outcome Measure Information:
Title
Number of atrial fibrillation detected on long duration ( 21 days) cardiac rythm holter monitoring
Description
Atrial fibrillation >= 30 secondes
Time Frame
Day 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Centre Hospitalier de Versailles
City
Le Chesnay
ZIP/Postal Code
78150
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27495831
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs