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

T

The Leeds Teaching Hospitals NHS Trust

Status

Unknown

Conditions

Mental Health Disorder
Cardiovascular Diseases
Dementia

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT04227418
EVALECG MEPS Study

Details and patient eligibility

About

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.)

Enrollment

1,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

1,500 participants in 2 patient groups

Mental Health
Treatment:
Device: 6 lead ECG monitoring
Device: 12 lead ECG monitoring
Device: Hand held ECG monitoring
Psychiatric
Treatment:
Device: 6 lead ECG monitoring
Device: 12 lead ECG monitoring
Device: Hand held ECG monitoring

Trial contacts and locations

1

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Central trial contact

Muzahir Tayebjee

Data sourced from clinicaltrials.gov

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