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出境医 / 临床实验 / Evaluation of Ambulatory ECG Telemetry for the Early Detection of Atrial Fibrillation During Hospital Assessment of Cerebral Infarction (TELEMETRIE)

Evaluation of Ambulatory ECG Telemetry for the Early Detection of Atrial Fibrillation During Hospital Assessment of Cerebral Infarction (TELEMETRIE)

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.

Condition or disease Intervention/treatment Phase
Cerebral Infarction Device: ECG telemetry Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Ambulatory ECG Telemetry for the Early Detection of Atrial Fibrillation During Hospital Assessment of Cerebral Infarction
Actual Study Start Date : December 27, 2018
Actual Primary Completion Date : July 3, 2019
Actual Study Completion Date : July 3, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: holter-ECG
Implementation of an ECG Holter during hospitalisation patient.
 Device: ECG telemetry
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
No Intervention: Crontrole
No implementation of an ECG Holter
Outcome Measures
Primary Outcome Measures :
  1. Diagnostic impact of outpatient ECG telemetry [ Time Frame: 6 months ]
    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 :
  1. Identification of prognostic factors to identify de novo atrial fibrillation [ Time Frame: 6 months ]
    Retrospective evaluation of prognostic criteria (clinical data, biomarkers, abdominal MRI) in patients with a diagnosis of AF

  2. Evaluate the therapeutic impact (prescription anticoagulant) at the end of hospitalisation [ Time Frame: 6 months ]
    Percentage of patients on anticoagulation at the end of hospitalisation

  3. Evaluate the benefit on the recurrence rate of cerebral infarction after the exit of the service [ Time Frame: 3 months ]
    Percentage of IC recurrence in the department and within 3 months of the IC diagnosis


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
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France
Hopital Foch
Suresnes, France, 92150
Sponsors and Collaborators
Hopital Foch
Investigators
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Principal Investigator: Bertrand Lapergue, MD Hopital Foch
Tracking Information
First Submitted Date  ICMJE June 18, 2019
First Posted Date  ICMJE June 20, 2019
Last Update Posted Date January 2, 2020
Actual Study Start Date  ICMJE December 27, 2018
Actual Primary Completion Date July 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2019) 		Diagnostic impact of outpatient ECG telemetry [ Time Frame: 6 months ]
Percentage of patients hospitalized for cerebral infarction and with a diagnosis of atrial fibrillation allowed by the use of ambulatory ECG telemetry.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • Identification of prognostic factors to identify de novo atrial fibrillation [ Time Frame: 6 months ]
    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 [ Time Frame: 6 months ]
    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 [ Time Frame: 3 months ]
    Percentage of IC recurrence in the department and within 3 months of the IC diagnosis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Ambulatory ECG Telemetry for the Early Detection of Atrial Fibrillation During Hospital Assessment of Cerebral Infarction
Official Title  ICMJE Evaluation of Ambulatory ECG Telemetry for the Early Detection of Atrial Fibrillation During Hospital Assessment of Cerebral Infarction
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Cerebral Infarction
Intervention  ICMJE Device: ECG telemetry
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
Study Arms  ICMJE
  • Experimental: holter-ECG
    Implementation of an ECG Holter during hospitalisation patient.
    Intervention: Device: ECG telemetry
  • No Intervention: Crontrole
    No implementation of an ECG Holter
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 30, 2019) 		8
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2019) 		370
Actual Study Completion Date  ICMJE July 3, 2019
Actual Primary Completion Date July 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03992157
Other Study ID Numbers  ICMJE 2016-38
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hopital Foch
Study Sponsor  ICMJE Hopital Foch
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bertrand Lapergue, MD Hopital Foch
PRS Account Hopital Foch
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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