Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-30 @ 11:16 PM
Study NCT ID:
NCT03835403
Status:
RECRUITING
Last Update Posted:
2022-12-08
First Post:
2019-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The HeartRunner Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058687', 'term': 'Out-of-Hospital Cardiac Arrest'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-03', 'size': 656963, 'label': 'Study Protocol and Statistical Analysis Plan: Updated protocol', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-12-04T09:50', 'hasProtocol': True}, {'date': '2020-12-03', 'size': 145151, 'label': 'Study Protocol: Changes to protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_004.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-12-04T09:58', 'hasProtocol': True}, {'date': '2020-12-03', 'size': 190435, 'label': 'Statistical Analysis Plan: Detailed Final Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-12-04T09:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1600}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-07', 'studyFirstSubmitDate': '2019-02-07', 'studyFirstSubmitQcDate': '2019-02-07', 'lastUpdatePostDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day survival', 'timeFrame': '30 days after date of out-of-hospital cardiac arrest', 'description': 'Patient alive 30 days after date of out-of-hospital cardiac arrest'}], 'secondaryOutcomes': [{'measure': 'Rates of bystander defibrillation', 'timeFrame': 'During cardiac arrest', 'description': 'Percentage of patients who received defibrillation prior to EMS arrival'}, {'measure': 'Rates of bystander cardiopulmonary resuscitation', 'timeFrame': 'During cardiac arrest', 'description': 'Percentage of patients who received bystander cardiopulmonary resuscitation prior to EMS arrival'}, {'measure': 'Rates of return of spontaneuous circulation', 'timeFrame': 'Immediately after out-of-hospital cardiac arrest', 'description': 'sustained circulation indicating successful resuscitation'}, {'measure': 'Rates of survival after 1 year', 'timeFrame': '1 year after date of out-of-hospital cardiac arrest', 'description': 'percentage of patients alive 1 year after out-of-hospital cardiac arrest'}, {'measure': 'Rates of neurological intact survival', 'timeFrame': 'At hospital discharge', 'description': 'percentage of patients with cerebral performance category score of 1-2'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Out-Of-Hospital Cardiac Arrest']}, 'referencesModule': {'references': [{'pmid': '35060395', 'type': 'DERIVED', 'citation': 'Mottlau KH, Andelius LC, Gregersen R, Malta Hansen C, Folke F. Citizen Responder Activation in Out-of-Hospital Cardiac Arrest by Time of Day and Day of Week. J Am Heart Assoc. 2022 Feb;11(3):e023413. doi: 10.1161/JAHA.121.023413. Epub 2022 Jan 21.'}, {'pmid': '32616162', 'type': 'DERIVED', 'citation': 'Andelius L, Malta Hansen C, Lippert FK, Karlsson L, Torp-Pedersen C, Kjaer Ersboll A, Kober L, Collatz Christensen H, Blomberg SN, Gislason GH, Folke F. Smartphone Activation of Citizen Responders to Facilitate Defibrillation in Out-of-Hospital Cardiac Arrest. J Am Coll Cardiol. 2020 Jul 7;76(1):43-53. doi: 10.1016/j.jacc.2020.04.073.'}]}, 'descriptionModule': {'briefSummary': "The study will assess 30-day survival for cases where volunteer citizen responders ('heart runners') were activated through a smartphone app to retrieve an AED in case of suspected out-of-hospital cardiac arrest (OHCA) versus standard emergency medical services care. The study will randomize emergency medical dispatch center incoming calls which are suspected out-of-hospital cardiac arrest, such that half will be randomized to activation of heart runners and half to no activation of heart runners (standard care). The study will also assess physical or psychological risks involved for the activated heart runners.", 'detailedDescription': 'Chances of survival after out-of-hospital cardiac arrest decrease 10% per minute from collapse until defibrillation. Activating volunteer citizens through the emergency medical dispatch center can potentially increase rates of bystander defibrillation and survival. The HeartRunner trial will investigage the effect of activating registered volunteer citizens through a mobile app integrated with the emergency medical services on 30-day survival following out-of-hospital cardiac arrest. Both arms will receive standard care by the Emergency Medical Services. The intervention arm will additionally receive the activation of volunteer citizen responders. The randomization will take place independently in 3 different strata according to heart runner distance to OHCA (\\< 3 min, 3-9 min, \\> 9 min). The trial will also assess whether it is safe, both physically and psychologically, to activate volunteer citizen responders to respond to out-of-hospital cardiac arrests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All out-of-hospital cardiac arrests recognized by Emergency Medical Dispatcher and where the HeartRunner system is activated.\n* Non-traumatic etiology, this excludes intoxication, drowning or suicide.\n* Age \\> 7 years\n\nExclusion Criteria:\n\n* Caller is not in direct contact with the patient\n* If Emergency Medical Dispatcher deems AED is not indicated, e.g., in nursing homes where trained personal is present.\n* OHCAs not treated by the EMS due to ethical reasons or obvious signs of death\n* OHCAs with no heart runners within 1800 meters\n* Not true cardiac arrest (suspected, but not verified)\n* EMS-witnessed OHCAs\n\nEmergency medical dispatchers are instructed not to activate heart runners in case any of the exclusion criteria above. However, since it can be challenging for emergency medical dispatchers to gather sufficient information about the patient within the first few minutes, heart runners will admittedly be activated even though they should not have been. Since randomization will occur for all cases in which a heart runner is activated, cases with any of the exclusion criteria will be secondarily excluded.\n\nThese cases will be accounted for but not included in analyses of outcome. Our pilot study showed approximately 60% of suspected cardiac arrests were true cardiac arrests. Therefore, we expect 40% of cases for which heart runners were dispatched not to be true cardiac arrests.'}, 'identificationModule': {'nctId': 'NCT03835403', 'briefTitle': 'The HeartRunner Trial', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Emergency Medical Services, Capital Region, Denmark'}, 'officialTitle': 'Public Access Defibrillation by Activated Citizen First-responders - The HeartRunner Trial', 'orgStudyIdInfo': {'id': 'The HeartRunner Trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care (control arm)', 'description': 'These cardiac arrests will receive standard EMS response.'}, {'type': 'EXPERIMENTAL', 'label': 'HeartRunner Activation', 'description': 'For these cardiac arrests, HeartRunners will be activated in addition to standard EMS response.', 'interventionNames': ['Other: Activation of HeartRunners']}], 'interventions': [{'name': 'Activation of HeartRunners', 'type': 'OTHER', 'description': 'Activation of volunteer citizen first-responders to respond to nearby cardiac arrests', 'armGroupLabels': ['HeartRunner Activation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'state': 'Ballerup', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Carolina Malta Hansen, MD, PhD', 'role': 'CONTACT', 'email': 'carolina.malta.hansen.01@regionh.dk'}, {'name': 'Fredrik Folke, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Linn C Andelius, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Emergency Medical Services Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Fredrik Folke, MD, PhD', 'role': 'CONTACT', 'email': 'ff@heart.dk', 'phone': '+45 28182978'}, {'name': 'Carolina Malta Hansen, MD, PhD', 'role': 'CONTACT', 'email': 'carolina.malta.hansen.01@regionh.dk', 'phone': '+4560126127'}], 'overallOfficials': [{'name': 'Fredrik Folke, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Copenhagen EMS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emergency Medical Services, Capital Region, Denmark', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'TrygFonden, Denmark', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Head of Research', 'investigatorFullName': 'Fredrik Folke', 'investigatorAffiliation': 'Emergency Medical Services, Capital Region, Denmark'}}}}