Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-29 @ 5:29 PM
Study NCT ID:
NCT04341506
Status:
UNKNOWN
Last Update Posted:
2020-09-09
First Post:
2020-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-contact ECG Sensor System for COVID19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-08', 'studyFirstSubmitDate': '2020-04-07', 'studyFirstSubmitQcDate': '2020-04-07', 'lastUpdatePostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ECG changes associated with COVID-19', 'timeFrame': '3 months', 'description': 'Assess different ECG changes in participants diagnosed with COVID-10'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['COVID-19', 'ECG', 'Arrhythmia'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is two-fold. First we would like to confirm that non-contact ECG provides equivalency to current contact methods of obtaining ECG data. Second we would like to investigate whether non-contact ECG can detect ECG changes prior to the onset symptoms from COVID19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '100 employees of Lake Forrest Memorial Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any employee of Lake Forrest Memorial Hospital presenting to work\n* Age greater than 18 years-old\n\nExclusion Criteria:\n\n* Age less than 18 years-old\n* Non-employee'}, 'identificationModule': {'nctId': 'NCT04341506', 'briefTitle': 'Non-contact ECG Sensor System for COVID19', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern Medicine'}, 'officialTitle': 'Evaluating Non-contact ECG Sensor System for Early Detection of COVID19', 'orgStudyIdInfo': {'id': '20-0407'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participant ECG', 'description': 'The study has one arm, I.e., we will collect daily ECGs in 100 participants and track their ECG over three months. We will then compare ECGs pre and post COVID-19 diagnosis in any participant diagnosed with COVID-19 to assess for any early ECG changes that may aid with diagnosing.', 'interventionNames': ['Device: Non-contact ECG']}], 'interventions': [{'name': 'Non-contact ECG', 'type': 'DEVICE', 'description': 'A non-contact ECG will be used to detect a patient cardiac electrical activity.', 'armGroupLabels': ['Participant ECG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60610', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andrew Gostine', 'role': 'CONTACT'}], 'facility': 'Northwestern Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Andrew Gostine, MD', 'role': 'CONTACT', 'email': 'andrew.gostine@nm.org', 'phone': '(312) 695-0061'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Andrew Gostine, MD', 'investigatorAffiliation': 'Northwestern Medicine'}}}}