Study Stopped
Medical practices have evolved and are not conform with the study procedure. Actually, all patients receive an ambulatory ECG telemetry monitoring
Evaluation of Ambulatory ECG Telemetry for the Early Detection of Atrial Fibrillation During Hospital Assessment of Cerebral Infarction
TELEMETRIE
1 other identifier
interventional
8
1 country
1
Brief Summary
The aim of the study is to show that an ambulatory ECG telemetry monitoring of some patients hospitalized for cerebral infarction increases the frequency of the diagnosis of atrial fibrillation, cause of their stroke, and reinforces the protection against recurrences.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 27, 2018
CompletedFirst Submitted
Initial submission to the registry
June 18, 2019
CompletedFirst Posted
Study publicly available on registry
June 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2019
CompletedJanuary 2, 2020
December 1, 2019
6 months
June 18, 2019
December 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic impact of outpatient ECG telemetry
Percentage of patients hospitalized for cerebral infarction and with a diagnosis of atrial fibrillation allowed by the use of ambulatory ECG telemetry.
6 months
Secondary Outcomes (3)
Identification of prognostic factors to identify de novo atrial fibrillation
6 months
Evaluate the therapeutic impact (prescription anticoagulant) at the end of hospitalisation
6 months
Evaluate the benefit on the recurrence rate of cerebral infarction after the exit of the service
3 months
Study Arms (2)
holter-ECG
EXPERIMENTALImplementation of an ECG Holter during hospitalisation patient.
Crontrole
NO INTERVENTIONNo implementation of an ECG Holter
Interventions
ECG telemetry (holter ECG) is a portable case - attached to the belt or around the neck - connected to 6 electrodes placed on the skin next to the heart. They are worn by patients during their stay in hospital
Eligibility Criteria
You may qualify if:
- Patients over 18 years old
- Diagnosis of transient ischemic or cerebral accident
- Absence of etiological orientation after the initial assessment (including at least cerebral MRI, angiography of the supra aortic trunks by CT or MRI, echocardiography with search for patent foramen ovale, standard biology)
- Affiliated to a social security system.
- Having given no opposition to participation in research
You may not qualify if:
- AF known or diagnosed during stay in USINV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Fochlead
Study Sites (1)
Hopital Foch
Suresnes, 92150, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bertrand Lapergue, MD
Hopital Foch
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2019
First Posted
June 20, 2019
Study Start
December 27, 2018
Primary Completion
July 3, 2019
Study Completion
July 3, 2019
Last Updated
January 2, 2020
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share