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Clinical Trials/NCT04227418
NCT04227418
Unknown
Not Applicable

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

The Leeds Teaching Hospitals NHS Trust1 site in 1 country1,500 target enrollmentJanuary 24, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
The Leeds Teaching Hospitals NHS Trust
Enrollment
1500
Locations
1
Primary Endpoint
ECG monitoring
Last Updated
6 years ago

Overview

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.)

Registry
clinicaltrials.gov
Start Date
January 24, 2020
End Date
August 31, 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
The Leeds Teaching Hospitals NHS Trust
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

ECG monitoring

Time Frame: 45 minutes

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

Study Sites (1)

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