Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT04445493
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2020-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EPISODE-PS-COVID: hEad Pulse for Ischemic StrOke DEtection Prehospital Study During the COVID-19 Pandemic ( EPISODEPSCOVID )
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 486}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-07', 'studyFirstSubmitDate': '2020-06-18', 'studyFirstSubmitQcDate': '2020-06-22', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of COVID-19 infection in suspected stroke population', 'timeFrame': 'Through Study Completion, an average of 6 months'}, {'measure': 'Quality head pulse recordings', 'timeFrame': 'Through Study Completion, an average 6 months', 'description': 'Proportion of head pulse studies deemed of high quality for further analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke, Acute', 'COVID-19']}, 'referencesModule': {'references': [{'pmid': '31591693', 'type': 'RESULT', 'citation': 'Smith WS, Keenan KJ, Lovoi PA. A Unique Signature of Cardiac-Induced Cranial Forces During Acute Large Vessel Stroke and Development of a Predictive Model. Neurocrit Care. 2020 Aug;33(1):58-63. doi: 10.1007/s12028-019-00845-x.'}]}, 'descriptionModule': {'briefSummary': 'Prehospital providers encounter patients with suspected stroke frequently. Stroke and COVID-19 are related potentially putting these healthcare workers at risk of COVID-19 infection. In addition, prehospital providers need tools to help triage large vessel stroke patients to comprehensive stroke centers.', 'detailedDescription': 'This observational prospective study will document COVID-19 status on patients seen in the prehospital environment for suspected stroke. This will provide an estimate of how frequently stroke occurs in stroke and also the exposure risk to providers in this setting.\n\nAdditionally, patients will have a headset placed to record their headpulse during the encounter. These measurements will be used to further develop an analytic model used to predict the presence of large vessel occlusion (LVO) stroke. This may help create a device that can be used in the prehospital environment to aid in the trade decision of destination hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are being evaluated in the prehospital environment by Detroit Paramedics/EMTs in whom stroke is suspected and who may be at risk fo COVID-19 infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* suspected stroke in the prehospital setting\n* patient at risk for COVID-19\n\nExclusion Criteria:\n\n* scalp laceration\n* Patient refusal\n* Prisoner, other vulnerable population\n* Prehospital provider feels that the recording may interfere with care'}, 'identificationModule': {'nctId': 'NCT04445493', 'acronym': 'EPISODE-PH-COV', 'briefTitle': 'EPISODE-PS-COVID: hEad Pulse for Ischemic StrOke DEtection Prehospital Study During the COVID-19 Pandemic ( EPISODEPSCOVID )', 'organization': {'class': 'INDUSTRY', 'fullName': 'MindRhythm, Inc.'}, 'officialTitle': 'EPISODE-PS-COVID: hEad Pulse for Ischemic StrOke DEtection Prehospital Study During the COVID-19 Pandemic', 'orgStudyIdInfo': {'id': 'EPISODE-PH-COVID'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Device: MindRhythm Harmony', 'description': 'Passive recording of the head pulse', 'interventionNames': ['Device: MindRhythm Harmony']}], 'interventions': [{'name': 'MindRhythm Harmony', 'type': 'DEVICE', 'otherNames': ['Cranial Accelerometry'], 'description': 'Passive recording of the head pulse', 'armGroupLabels': ['Device: MindRhythm Harmony']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'overallOfficials': [{'name': 'James Paxton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wayne State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MindRhythm, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Wayne State University', 'class': 'OTHER'}, {'name': 'Western Michigan University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}