Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-25 @ 8:32 PM
Study NCT ID:
NCT05230069
Status:
UNKNOWN
Last Update Posted:
2022-02-08
First Post:
2022-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Emergency Call for Heart Attack and Stroke (ECHAS) - ECHAS One Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-28', 'studyFirstSubmitDate': '2022-01-28', 'studyFirstSubmitQcDate': '2022-01-28', 'lastUpdatePostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Appropriate Emergency Activation', 'timeFrame': '3 months', 'description': 'Was the right call made for a possible heart attack or stroke'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Triage', 'Smartphone'], 'conditions': ['Heart Attack and Stroke']}, 'descriptionModule': {'briefSummary': 'ECHAS One will test the use of a smartphone app to assist patients to decide if it is necessary to call for emergency care with symptoms that could represent a heart attack or stroke.', 'detailedDescription': 'The ECHAS One Study will be conducted in 200 patients who have already called for emergency care for a heart or stroke, and have been evaluated. The endpoint of the study will be a decision if the initial call was an appropriate call for emergency care. The sensitivity of the app for detecting appropriate calls will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '200 patients who activated emergency system for symptoms of possible heart attack or stroke.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presented to ED via emergency medical services (EMS) for "Stroke alert" symptoms, including:\n\nSlurred speech Asymmetric weakness or numbness Balance problems Vision changes Headache\n\nAnd/or "MI alert" symptoms including:\n\nChest discomfort Chest pressure or pain Palpitations Shortness of breath Lightheadedness or presyncope Syncope Age ≥ 18 years Able to provide informed consent\n\nExclusion Criteria:\n\n* Non-English speaking\n* Moderate or greater dementia\n* Severe visual impairment\n* Inability to use smartphone (for physical, cognitive, or other reasons)\n* Unable to consent for study'}, 'identificationModule': {'nctId': 'NCT05230069', 'acronym': 'ECHAS', 'briefTitle': 'Emergency Call for Heart Attack and Stroke (ECHAS) - ECHAS One Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Emergency Call for Heart Attack and Stroke (ECHAS)'}, 'officialTitle': 'Assessment of a Prehospital Mobile App and Sensor Triage System to Detect Neurologic and Cardiac Emergencies: The ECHAS Assessment Study (ECHAS- One)', 'orgStudyIdInfo': {'id': 'ECHAS One'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients post emergency evaluation', 'description': 'Interview of patients post notification of emergency system', 'interventionNames': ['Other: Interview']}], 'interventions': [{'name': 'Interview', 'type': 'OTHER', 'description': 'Patients will be interviewed post an emergency call and evaluation.', 'armGroupLabels': ['Patients post emergency evaluation']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'James E Muller', 'role': 'CONTACT', 'email': 'james.muller19@gmail.com', 'phone': '6177178570'}], 'overallOfficials': [{'name': 'James E Muller', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CEO, ECHAS, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emergency Call for Heart Attack and Stroke (ECHAS)', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Saskatchewan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}