Cardiovascular DiseasesNCT04227418
An Evaluation of the Safety and Clinical Utility of Handheld ECG Technology in Psychiatry
An observational study of Cardiovascular Diseases and Dementia, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Acetylcholinesterase inhibitors and antipsychotics are drugs commonly prescribed in psychiatry, the former for dementia and the latter for acute and chronic psychotic illness. Both can cause cardiac arrhythmia therefore 12 lead ECG's are recommended before prescribing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Dementia, Mental Health Disorder
- What is being tested?
- 12 lead ECG monitoring, 6 lead ECG monitoring and Hand held ECG monitoring
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 1,500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Jan 2020to 31 Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adults, 18 and over, attending memory clinic with a new diagnosis of Alzheimer's, Mixed or Lewy Body type dementia indicated for AChIE treatment, will be invited to participate. These are patients who would be indicated to have an ECG as part of routine practice. All general adult and old age inpatient wards in Leeds and York Partnership NHS Foundation Trust.
Who may be able to join
- Any patient attending the memory clinic Any patient admitted to the acute psychiatric ward requiring antipsychotic medication
Who cannot join
- Patients who lack capacity and do not have a personal consultee to provide assent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Partnership NHS Foundation Trust
Leeds, West Yorkshire, LS7 9TF
George Crowther, MBChB PhD, georgecrowther@nhs.net
About this study
Acetylcholinesterase inhibitors and antipsychotics are drugs commonly prescribed in psychiatry, the former for dementia and the latter for acute and chronic psychotic illness. Both can cause cardiac arrhythmia therefore 12 lead ECG's are recommended before prescribing. The test is often difficult to obtain however, leading to either patients being inconvenienced or drugs prescribed without the test. There are two parts of this study, but both examine the utility of single lead ecg monitoring, one in the memory clinic and the other in inpatient psychiatry wards. The aim to to evaluate the safety and efficacy of the handheld ecg versus the 12 lead and 6 lead ecg, and whether the handheld ecg can be used to screen for ecg abnormalities that would generally lead to a caution or contra-indication for acetylcholinesterase inhibitors and anti-psychotic medication.
Patients will either be recruited from the outpatient memory clinic or in patient psychiatry wards. Following informed consent baseline demographic data will be collected, and patients will undergo a 12 lead and 6 lead ECG as well as a rhythm strip using the handheld device. Data from this point will be annonymised for future analysis. The psychiatrists ECG report will also be recorded, and a subset of patients will undergo an echocardiogram (to see what proportion of patients with psychiatric disorders have structural heart disease.)
- Conditions
- Cardiovascular Diseases, Dementia, Mental Health Disorder
- Being tested
- 12 lead ECG monitoring, 6 lead ECG monitoring, Hand held ECG monitoring
- Medical subject headings
- Cardiovascular Diseases, Dementia, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 lead ECG monitoringDevice
Rate, Rhythm, QTc and PR interval will be assessed
6 lead ECG monitoringDevice
Rate, Rhythm, QTc and PR interval will be assessed
Hand held ECG monitoringDevice
Also called AliveCor ECG device
Handheld ECG machines are portable, inexpensive, hand held devices that provide a 'real-time' rhythm strip, equivalent to lead I or II on a 12 lead machine, depending on how the device is held. The rhythm strip is displayed on a computer tablet or mobile phone, and are compatible with both android and iPhone platforms. To perform the test the patient places their fingers/thigh, or alternatively the device can be placed directly on the patient's chest. The process does not require the patient to be exposed, can be done in a seated position (negating the need an examination couch) and their ease of use and portability means they could be readily used in memory clinics or community settings.
| Study group | Role | What they receive |
|---|---|---|
| Mental Health | Not described Receives: Device: 12 lead ECG monitoring; Device: 6 lead ECG monitoring; Device: Hand held ECG monitoring | |
| Psychiatric | Not described Receives: Device: 12 lead ECG monitoring; Device: 6 lead ECG monitoring; Device: Hand held ECG monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG monitoring
12 lead, 6 lead and handheld ECG device monitoring will be undertaken.
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start24 Jan 2020
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Leeds and York Partnership NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227418
- Sponsor's protocol ID
- EVALECG MEPS Study
- Status last verified
- Feb 2020
- First submitted
- 4 Nov 2019
- Last updated
- 11 Feb 2020
- 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 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Safety and Clinical Utility of Handheld ECG Technology in Psychiatry
- ClinicalTrials.gov ID
- NCT04227418
- Acronym / sponsor ID
- EVALECG MEPS Study
- Conditions
- Cardiovascular Diseases, Dementia, Mental Health Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Leeds and York Partnership NHS Foundation Trust
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 13 Jan 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.
Acetylcholinesterase inhibitors and antipsychotics are drugs commonly prescribed in psychiatry, the former for dementia and the latter for acute and chronic psychotic illness. Both can cause cardiac arrhythmia therefore 12 lead ECG's are recommended before prescribing. The test is often difficult to obtain however, leading to either patients being inconvenienced or drugs prescribed without the test. There are two parts of this study, but both examine the utility of single lead ecg monitoring, one in the memory clinic and the other in inpatient psychiatry wards. The aim to to evaluate the safety and efficacy of the handheld ecg versus the 12 lead and 6 lead ecg, and whether the handheld ecg can be used to screen for ecg abnormalities that would generally lead to a caution or contra-indication for acetylcholinesterase inhibitors and anti-psychotic medication.
Patients will either be recruited from the outpatient memory clinic or in patient psychiatry wards. Following informed consent baseline demographic data will be collected, and patients will undergo a 12 lead and 6 lead ECG as well as a rhythm strip using the handheld device. Data from this point will be annonymised for future analysis. The psychiatrists ECG report will also be recorded, and a subset of patients will undergo an echocardiogram (to see what proportion of patients with psychiatric disorders have structural heart disease.)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mental Health | – | Device: 12 lead ECG monitoring, Device: 6 lead ECG monitoring, Device: Hand held ECG monitoring |
| Psychiatric | – | Device: 12 lead ECG monitoring, Device: 6 lead ECG monitoring, Device: Hand held ECG monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults, 18 and over, attending memory clinic with a new diagnosis of Alzheimer's, Mixed or Lewy Body type dementia indicated for AChIE treatment, will be invited to participate. These are patients who would be indicated to have an ECG as part of routine practice. All general adult and old age inpatient wards in Leeds and York Partnership NHS Foundation Trust.
Key inclusion criteria (1 listed)
- Any patient attending the memory clinic Any patient admitted to the acute psychiatric ward requiring antipsychotic medication
Key exclusion criteria (1 listed)
- Patients who lack capacity and do not have a personal consultee to provide assent
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 |
|---|---|---|
| 12 lead ECG monitoringRate, Rhythm, QTc and PR interval will be assessed | Device | Mental Health, Psychiatric |
| 6 lead ECG monitoringRate, Rhythm, QTc and PR interval will be assessed | Device | Mental Health, Psychiatric |
| Hand held ECG monitoringAlso: AliveCor ECG deviceHandheld ECG machines are portable, inexpensive, hand held devices that provide a 'real-time' rhythm strip, equivalent to lead I or II on a 12 lead machine, depending on how the device is held. The rhythm strip is displayed on a computer tablet or mobile phone, and are compatible with both android and iPhone platforms. To perform the test the patient places their fingers/thigh, or alternatively the device can be placed directly on the patient's chest. The process does not require the patient to be exposed, can be done in a seated position (negating the need an examination couch) and their ease of use and portability means they could be readily used in memory clinics or community settings. | Device | Mental Health, Psychiatric |
Primary outcome
ECG monitoring
Time frame: 45 minutes
12 lead, 6 lead and handheld ECG device monitoring will be undertaken.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
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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.
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 Cardiovascular Diseases and Dementia, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 1 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: status not confirmed, as of the sponsor's last update on 11 Feb 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muzahir Tayebjee (+441133926619, muzahir.tayebjee@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECG monitoring (time frame: 45 minutes). 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 11 Feb 2020.