Last reviewed · How we verify
NCT04227418
An Evaluation of the Safety and Clinical Utility of Handheld ECG Technology in Psychiatry
trial testing 12 lead ECG monitoring in Cardiovascular Diseases in 1,500 participants. Status unknown.
31 August 2021
Quick facts
| Lead sponsor | The Leeds Teaching Hospitals NHS Trust |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 1,500 |
| Start date | 24 January 2020 |
| Primary completion | 31 August 2021 |
| Estimated completion | 31 August 2021 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- 12 lead ECG monitoring
- 6 lead ECG monitoring
- Hand held ECG monitoring
Conditions studied
- Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
- Dementia — all drugs for Dementia →
- Mental Health Disorder — all drugs for Mental Health Disorder →
Sponsor
The Leeds Teaching Hospitals NHS Trust
Who can join
18 and older, any sex, with Cardiovascular Diseases or Dementia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.)
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04227418
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04227418 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Leeds Teaching Hospitals NHS Trust
- Last refreshed: 11 February 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04227418.
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