Back to resultsEvaluation of Ambulatory ECG Telemetry for the Early Detection of Atrial Fibrillation During Hospital Assessment of Cerebral Infarction (TELEMETRIE)
Primary Purpose
Cerebral Infarction
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ECG telemetry
Sponsored by
About this trial
This is an interventional diagnostic trial for Cerebral Infarction focused on measuring stroke, ECG, telemetry, atrial fibrillation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- AF known or diagnosed during stay in USINV
Sites / Locations
- Hopital Foch
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
holter-ECG
Crontrole
Arm Description
Implementation of an ECG Holter during hospitalisation patient.
No implementation of an ECG Holter
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Identification of prognostic factors to identify de novo atrial fibrillation
Retrospective evaluation of prognostic criteria (clinical data, biomarkers, abdominal MRI) in patients with a diagnosis of AF
Evaluate the therapeutic impact (prescription anticoagulant) at the end of hospitalisation
Percentage of patients on anticoagulation at the end of hospitalisation
Evaluate the benefit on the recurrence rate of cerebral infarction after the exit of the service
Percentage of IC recurrence in the department and within 3 months of the IC diagnosis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03992157
Brief Title
Evaluation of Ambulatory ECG Telemetry for the Early Detection of Atrial Fibrillation During Hospital Assessment of Cerebral Infarction
Acronym
TELEMETRIE
Official Title
Evaluation of Ambulatory ECG Telemetry for the Early Detection of Atrial Fibrillation During Hospital Assessment of Cerebral Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
Medical practices have evolved and are not conform with the study procedure. Actually, all patients receive an ambulatory ECG telemetry monitoring
Study Start Date
December 27, 2018 (Actual)
Primary Completion Date
July 3, 2019 (Actual)
Study Completion Date
July 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Infarction
Keywords
stroke, ECG, telemetry, atrial fibrillation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
holter-ECG
Arm Type
Experimental
Arm Description
Implementation of an ECG Holter during hospitalisation patient.
Arm Title
Crontrole
Arm Type
No Intervention
Arm Description
No implementation of an ECG Holter
Intervention Type
Device
Intervention Name(s)
ECG telemetry
Intervention Description
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
Primary Outcome Measure Information:
Title
Diagnostic impact of outpatient ECG telemetry
Description
Percentage of patients hospitalized for cerebral infarction and with a diagnosis of atrial fibrillation allowed by the use of ambulatory ECG telemetry.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Identification of prognostic factors to identify de novo atrial fibrillation
Description
Retrospective evaluation of prognostic criteria (clinical data, biomarkers, abdominal MRI) in patients with a diagnosis of AF
Time Frame
6 months
Title
Evaluate the therapeutic impact (prescription anticoagulant) at the end of hospitalisation
Description
Percentage of patients on anticoagulation at the end of hospitalisation
Time Frame
6 months
Title
Evaluate the benefit on the recurrence rate of cerebral infarction after the exit of the service
Description
Percentage of IC recurrence in the department and within 3 months of the IC diagnosis
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
AF known or diagnosed during stay in USINV
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand Lapergue, MD
Organizational Affiliation
Hopital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Ambulatory ECG Telemetry for the Early Detection of Atrial Fibrillation During Hospital Assessment of Cerebral Infarction
We'll reach out to this number within 24 hrs