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

Cerebral Infarction Clinical Trial

— TELEMETRIE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03992157
• Other study ID #: 2016-38
• Status: Terminated
• Phase: N/A
• Start date: December 27, 2018
• Est. completion date: July 3, 2019

Study information

• Verified date: December 2019
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: July 3, 2019
• Est. primary completion date: July 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cerebral Infarction
• Infarction

Intervention

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

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	6 months
Secondary	Evaluate the therapeutic impact (prescription anticoagulant) at the end of hospitalisation	Percentage of patients on anticoagulation at the end of hospitalisation	6 months
Secondary	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	3 months