NCT04227418

Brief 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. 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.)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

January 24, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

1.6 years

First QC Date

November 4, 2019

Last Update Submit

February 10, 2020

Conditions

Cardiovascular DiseasesDementiaMental Health Disorder

Outcome Measures

Primary Outcomes (1)

  • ECG monitoring

    12 lead, 6 lead and handheld ECG device monitoring will be undertaken.

    45 minutes

Study Arms (2)

Mental Health

Device: 12 lead ECG monitoringDevice: 6 lead ECG monitoringDevice: Hand held ECG monitoring

Psychiatric

Device: 12 lead ECG monitoringDevice: 6 lead ECG monitoringDevice: Hand held ECG monitoring

Interventions

12 lead ECG monitoringDEVICE

Rate, Rhythm, QTc and PR interval will be assessed

Mental HealthPsychiatric
6 lead ECG monitoringDEVICE

Rate, Rhythm, QTc and PR interval will be assessed

Mental HealthPsychiatric
Hand held ECG monitoringDEVICE

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.

Also known as: AliveCor ECG device
Mental HealthPsychiatric

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Any patient attending the memory clinic Any patient admitted to the acute psychiatric ward requiring antipsychotic medication

You may not qualify if:

  • Patients who lack capacity and do not have a personal consultee to provide assent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leeds Partnership NHS Foundation Trust

Leeds, West Yorkshire, LS7 9TF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cardiovascular DiseasesDementiaMental Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive Disorders

Central Study Contacts

Muzahir Tayebjee

CONTACT

+441133926619muzahir.tayebjee@nhs.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2019

First Posted

January 13, 2020

Study Start

January 24, 2020

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

February 11, 2020

Record last verified: 2020-02

Locations

GB(1)