An Evaluation of the Safety and Clinical Utility of Handheld ECG Technology in Psychiatry

Cardiovascular Diseases Clinical Trial

Official title:

An Evaluation of the Safety and Clinical Utility of Handheld ECG Technology in Psychiatry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04227418
• Other study ID #: EVALECG MEPS Study
• Status: Recruiting
• Start date: January 24, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: February 2020
• Source: The Leeds Teaching Hospitals NHS Trust
• Contact: Muzahir Tayebjee
• Phone: +441133926619
• Email: muzahir.tayebjee[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Dementia
• Mental Disorders
• Mental Health Disorder

Intervention

Device:
• 12 lead ECG monitoring
Rate, Rhythm, QTc and PR interval will be assessed
• 6 lead ECG monitoring
Rate, Rhythm, QTc and PR interval will be assessed
• Hand held ECG monitoring
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.

Locations

Country	Name	City	State
United Kingdom	Leeds Partnership NHS Foundation Trust	Leeds	West Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
The Leeds Teaching Hospitals NHS Trust	Leeds and York Partnership NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ECG monitoring	12 lead, 6 lead and handheld ECG device monitoring will be undertaken.	45 minutes