Cerebral InfarctionTELEMETRIENCT03992157
Evaluation of Ambulatory ECG Telemetry for the Early Detection of Atrial Fibrillation During Hospital Assessment of Cerebral Infarction
A study testing ECG telemetry in people with Cerebral Infarction, run by Hopital Foch at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Infarction
- What is being tested?
- ECG telemetry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 27 Dec 2018to 3 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- AF known or diagnosed during stay in USINV
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cerebral Infarction
- Being tested
- ECG telemetry
- Keywords
- stroke, ECG, telemetry, atrial fibrillation
- Medical subject headings
- Cerebral Infarction, Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG telemetryDevice
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 group | Role | What they receive |
|---|---|---|
| holter-ECG | Experimental | Implementation of an ECG Holter during hospitalisation patient. Receives: Device: ECG telemetry |
| Crontrole | No intervention | No implementation of an ECG Holter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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
Measured: 6 months
Evaluate the therapeutic impact (prescription anticoagulant) at the end of hospitalisation
Percentage of patients on anticoagulation at the end of hospitalisation
Measured: 6 months
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start27 Dec 2018
- Primary completion3 Jul 2019
- Study completion3 Jul 2019
Why it stopped: Medical practices have evolved and are not conform with the study procedure. Actually, all patients receive an ambulatory ECG telemetry monitoring
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand Lapergue, MD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992157
- Sponsor's protocol ID
- 2016-38
- Acronym
- TELEMETRIE
- Status last verified
- Dec 2019
- First submitted
- 18 Jun 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ambulatory ECG Telemetry for the Early Detection of Atrial Fibrillation During Hospital Assessment of Cerebral Infarction
- ClinicalTrials.gov ID
- NCT03992157
- Acronym / sponsor ID
- TELEMETRIE / 2016-38
- Conditions
- Cerebral Infarction
- Keywords
- stroke, ECG, telemetry, atrial fibrillation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Medical practices have evolved and are not conform with the study procedure. Actually, all patients receive an ambulatory ECG telemetry monitoring
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 27 Dec 2018 (actual)
- Primary completion
- 3 Jul 2019 (actual)
- Study completion
- 3 Jul 2019 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| holter-ECG | Experimental | Device: ECG telemetryImplementation of an ECG Holter during hospitalisation patient. |
| Crontrole | No intervention | –No implementation of an ECG Holter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- AF known or diagnosed during stay in USINV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG telemetryECG 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 | Device | holter-ECG |
Primary outcome
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.
3 secondary outcomes
Identification of prognostic factors to identify de novo atrial fibrillation
Time frame: 6 months
Evaluate the therapeutic impact (prescription anticoagulant) at the end of hospitalisation
Time frame: 6 months
Evaluate the benefit on the recurrence rate of cerebral infarction after the exit of the service
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Medical practices have evolved and are not conform with the study procedure. Actually, all patients receive an ambulatory ECG telemetry monitoring). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertrand Lapergue, MD principal investigator
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECG telemetry in people with Cerebral Infarction, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Medical practices have evolved and are not conform with the study procedure. Actually, all patients receive an ambulatory ECG telemetry monitoring). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic impact of outpatient ECG telemetry (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.