Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT04227418
Status:
UNKNOWN
Last Update Posted:
2020-02-11
First Post:
2019-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Evaluation of the Safety and Clinical Utility of Handheld ECG Technology in Psychiatry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-10', 'studyFirstSubmitDate': '2019-11-04', 'studyFirstSubmitQcDate': '2020-01-10', 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ECG monitoring', 'timeFrame': '45 minutes', 'description': '12 lead, 6 lead and handheld ECG device monitoring will be undertaken.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases', 'Dementia', 'Mental Health Disorder']}, 'descriptionModule': {'briefSummary': "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.\n\nPatients 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.)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "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.\n\nAll general adult and old age inpatient wards in Leeds and York Partnership NHS Foundation Trust.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAny patient attending the memory clinic Any patient admitted to the acute psychiatric ward requiring antipsychotic medication\n\nExclusion Criteria:\n\nPatients who lack capacity and do not have a personal consultee to provide assent'}, 'identificationModule': {'nctId': 'NCT04227418', 'briefTitle': 'An Evaluation of the Safety and Clinical Utility of Handheld ECG Technology in Psychiatry', 'organization': {'class': 'OTHER', 'fullName': 'The Leeds Teaching Hospitals NHS Trust'}, 'officialTitle': 'An Evaluation of the Safety and Clinical Utility of Handheld ECG Technology in Psychiatry', 'orgStudyIdInfo': {'id': 'EVALECG MEPS Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mental Health', 'interventionNames': ['Device: 12 lead ECG monitoring', 'Device: 6 lead ECG monitoring', 'Device: Hand held ECG monitoring']}, {'label': 'Psychiatric', 'interventionNames': ['Device: 12 lead ECG monitoring', 'Device: 6 lead ECG monitoring', 'Device: Hand held ECG monitoring']}], 'interventions': [{'name': '12 lead ECG monitoring', 'type': 'DEVICE', 'description': 'Rate, Rhythm, QTc and PR interval will be assessed', 'armGroupLabels': ['Mental Health', 'Psychiatric']}, {'name': '6 lead ECG monitoring', 'type': 'DEVICE', 'description': 'Rate, Rhythm, QTc and PR interval will be assessed', 'armGroupLabels': ['Mental Health', 'Psychiatric']}, {'name': 'Hand held ECG monitoring', 'type': 'DEVICE', 'otherNames': ['AliveCor ECG device'], 'description': "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.", 'armGroupLabels': ['Mental Health', 'Psychiatric']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS7 9TF', 'city': 'Leeds', 'state': 'West Yorkshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'George Crowther, MBChB PhD', 'role': 'CONTACT', 'email': 'georgecrowther@nhs.net'}], 'facility': 'Leeds Partnership NHS Foundation Trust', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'centralContacts': [{'name': 'Muzahir Tayebjee', 'role': 'CONTACT', 'email': 'muzahir.tayebjee@nhs.net', 'phone': '+441133926619'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Leeds Teaching Hospitals NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Leeds and York Partnership NHS Foundation Trust', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}