An observational study in Cardiovascular Diseases, Dementia and Mental Health Disorder, sponsored by The Leeds Teaching Hospitals NHS Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-11.
Sponsored by The Leeds Teaching Hospitals NHS Trust · Observational
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.)
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →The Leeds Teaching Hospitals NHS Trust is the lead sponsor of 95 studies on the registry; 15 are open to participants now.
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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.
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
Device: 12 lead ECG monitoring · Device: 6 lead ECG monitoring · Device: Hand held ECG monitoring
Device: 12 lead ECG monitoring · Device: 6 lead ECG monitoring · Device: Hand held ECG monitoring
Rate, Rhythm, QTc and PR interval will be assessed
Rate, Rhythm, QTc and PR interval will be assessed
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
ECG monitoring
12 lead, 6 lead and handheld ECG device monitoring will be undertaken.
Time frame: 45 minutes
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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The Leeds Teaching Hospitals NHS Trust