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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03992157
Other study ID # 2016-38
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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