Cardiac PathologyTEECADNCT04357405
Study of the Interest of ECG Teletransmission in Retirement Home (EHPAD) In the Ile-de-France Region.
An observational study of Cardiac Pathology and Residents of Retirement Home (EHPAD), run by Gérond'if at 1 site in France.
Trial summary
The aim of the study is to evaluate the interest and the workability of ECG teletranmission in EHPAD in Île-de-France. ECG for the elderly is beneficial to detect or monitor cardiovascular disease. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cardiac Pathology, Residents of Retirement Home (EHPAD)
- How many people
- 430 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2019to 8 Apr 2021
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients living in nursing homes (EHPAD) requiring an electrocadiogram (ECG) except emergency situation, due to a cardiac pathology with / or without treatment which can lead to ECG abnormalities
Who may be able to join
- Elderly living in nursing homes (EHPAD) who requires electrocadiogram (ECG) due to :
- Cardiac pathology : coronary artery disease, heart failure, high blood pressure, diabetes, valvular disease, atrial fibrillation
- A medication which could causes electrocadiogram (ECG) anomalies Patients living in nursing homes (EHPAD) who give their agreement.
Who cannot join
- Protected adult under a protection of the court
Trial locations and contacts
1 site in 1 country.
France1 site
Psychiatric Geriatric Department, Broca hospital
Paris, Île-de-France Region, 75013
About this study
The aim of the study is to evaluate the interest and the workability of ECG teletranmission in EHPAD in Île-de-France. ECG for the elderly is beneficial to detect or monitor cardiovascular disease.
Read the detailed description
Main objectives :
- Evaluate the workability of ECG uploaded by a caregiver who was trained before
- Evaluate the prevalence of ECG anomalies highlighted thanks to the realisation of an uploaded ECG (supraventricular and ventricular rhythm disorder and coronary pathology)
Secondaries objectives :
- Evaluate the prevalence of unknown ECG anomalies and thus determine the number of new diagnostics highlighted thanks to uploaded ECG
- Evaluate the prevalence of ECG iatrogenic anomalies
The study is observational, multicentre and prospective. It is going to include 3211 elderly living in EHPAD in Île-de-France. 150 EHPAD or involved in the study, they are split in two groups : 100 EHPAD will receive ECG and 50 EHPAD will not. This last group will enable to lead a comparative analysis, only global data about death will be collected.
The study will last 36 months with 12 months of participation for each resident.
- Keywords
- ECG, Elderly EHPAD's resident, Cardiac desease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | This group consists of 100 EHPAD which will benefit from ECG teletransmission. all data will be collected | |
| Control arm | This arm consists of 50 EHPAD that have not benefited from ECG teletransmission. Only the global death occurrence data will be analyzed, no individual data will be collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of teletransmetted electrocardiogram (ECG) feasability (number of ECGs interpretable)
An interpretable ECG is defined by an absence of parasite, a stable baseline, an absence of argument of a malposition of electrodes, an unwinding paper speed: 25 mm / sec, a calibration of the amplitude
Measured: 12 months
Assessment of prevalence of anomalies highlighted by performing an electrocardiogram.
The prevalence of anomalies highlighted by performing an electrocardiogram: supra-ventricular rhythm disorders, ventricular rhythm disorder and coronary pathologies.
Measured: 12 months
Secondary outcomes (2)
Assessment of commorbidity risk and life expectancy according Charlson score.
Measured: 12 months
Assessment of prevalence of unknown and iatrogenic anomalies according to the electrocardiogram
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start6 Jun 2019
- Primary completion7 Jul 2020
- Study completion8 Apr 2021
Why it stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac PathologyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Hanon, MD PhD, Study chair, Psychiatric Geriatric Department, Broca hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357405
- Sponsor's protocol ID
- 2017-A02647-46
- Acronym
- TEECAD
- Status last verified
- Sep 2022
- First submitted
- 16 Apr 2020
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Interest of ECG Teletransmission in Retirement Home (EHPAD) In the Ile-de-France Region.
- ClinicalTrials.gov ID
- NCT04357405
- Acronym / sponsor ID
- TEECAD / 2017-A02647-46
- Keywords
- ECG, Elderly EHPAD's resident, Cardiac desease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 7 Jul 2020 (actual)
- Study completion
- 8 Apr 2021 (actual)
- First posted
- 22 Apr 2020 (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 evaluate the interest and the workability of ECG teletranmission in EHPAD in Île-de-France. ECG for the elderly is beneficial to detect or monitor cardiovascular disease.
Detailed description
Main objectives :
- Evaluate the workability of ECG uploaded by a caregiver who was trained before
- Evaluate the prevalence of ECG anomalies highlighted thanks to the realisation of an uploaded ECG (supraventricular and ventricular rhythm disorder and coronary pathology)
Secondaries objectives :
- Evaluate the prevalence of unknown ECG anomalies and thus determine the number of new diagnostics highlighted thanks to uploaded ECG
- Evaluate the prevalence of ECG iatrogenic anomalies
The study is observational, multicentre and prospective. It is going to include 3211 elderly living in EHPAD in Île-de-France. 150 EHPAD or involved in the study, they are split in two groups : 100 EHPAD will receive ECG and 50 EHPAD will not. This last group will enable to lead a comparative analysis, only global data about death will be collected.
The study will last 36 months with 12 months of participation for each resident.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | – | –This group consists of 100 EHPAD which will benefit from ECG teletransmission. all data will be collected |
| Control arm | – | –This arm consists of 50 EHPAD that have not benefited from ECG teletransmission. Only the global death occurrence data will be analyzed, no individual data will be collected. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients living in nursing homes (EHPAD) requiring an electrocadiogram (ECG) except emergency situation, due to a cardiac pathology with / or without treatment which can lead to ECG abnormalities
Key inclusion criteria (3 listed)
- Cardiac pathology : coronary artery disease, heart failure, high blood pressure, diabetes, valvular disease, atrial fibrillation
- A medication which could causes electrocadiogram (ECG) anomalies Patients living in nursing homes (EHPAD) who give their agreement.
Key exclusion criteria (1 listed)
- Protected adult under a protection of the court
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of teletransmetted electrocardiogram (ECG) feasability (number of ECGs interpretable)
Time frame: 12 months
An interpretable ECG is defined by an absence of parasite, a stable baseline, an absence of argument of a malposition of electrodes, an unwinding paper speed: 25 mm / sec, a calibration of the amplitude
Assessment of prevalence of anomalies highlighted by performing an electrocardiogram.
Time frame: 12 months
The prevalence of anomalies highlighted by performing an electrocardiogram: supra-ventricular rhythm disorders, ventricular rhythm disorder and coronary pathologies.
2 secondary outcomes
Assessment of commorbidity risk and life expectancy according Charlson score.
Time frame: 12 months
Assessment of prevalence of unknown and iatrogenic anomalies according to the electrocardiogram
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
Related trials for Cardiac Pathology
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
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.
Olivier Hanon, MD PhD study chair
Psychiatric Geriatric Department, Broca hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Pathology and Residents of Retirement Home (EHPAD), run by Gérond'if 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 3 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 29 Sep 2022. 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: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention). 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?
Assessment of teletransmetted electrocardiogram (ECG) feasability (number of ECGs interpretable) (time frame: 12 months). The study lists 2 primary outcomes in all. 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 29 Sep 2022.