Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-24 @ 4:36 PM
Study NCT ID:
NCT03940066
Status:
COMPLETED
Last Update Posted:
2025-04-06
First Post:
2019-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Ambulatory Monitoring of Patients After High-risk Acute Coronary Syndrome Using Two Different Systems: Biomonitor-2 and Kardia Mobile
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D013575', 'term': 'Syncope'}, {'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 169}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2019-05-05', 'studyFirstSubmitQcDate': '2019-05-05', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Atrial fibrilation (AF / atrial flutter)', 'timeFrame': '1 year', 'description': 'Detection rates for atrial fibrilation (AF / atrial flutter) during the follow up.'}, {'measure': 'Ventricular arrhythmia in the electrocardiogram (EKG)', 'timeFrame': '1 year', 'description': 'Detection rates of ventricular arrhythmia in the electrocardiogram (EKG) during the follow up.'}, {'measure': 'Advanced conduction abnormalities and significant ST shifts (> 1 mm) in the EKG', 'timeFrame': '1 year', 'description': 'Detection rates of advanced conduction abnormalities and significant ST shifts (\\> 1 mm) in the EKG.'}], 'secondaryOutcomes': [{'measure': 'Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)', 'timeFrame': '1 year', 'description': 'MACCE rates defined as cardiovascular and cerebrovascular events during the follow up.'}, {'measure': 'Re-hospitalization', 'timeFrame': '1 year', 'description': 'Number of Re-hospitalization during the follow up.'}, {'measure': 'Correlation of primary outcomes between Biomonitor-2 versus Kardia Mobile', 'timeFrame': '1 year', 'description': 'Correlation of primary outcomes between Biomonitor-2 versus Kardia Mobile during the follow up.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac Monitor'], 'conditions': ['Atrial Fibrillation', 'Syncope', 'Tachycardia', 'Arrhythmias, Cardiac', 'Heart Diseases']}, 'referencesModule': {'references': [{'pmid': '25586123', 'type': 'BACKGROUND', 'citation': 'Jernberg T, Hasvold P, Henriksson M, Hjelm H, Thuresson M, Janzon M. Cardiovascular risk in post-myocardial infarction patients: nationwide real world data demonstrate the importance of a long-term perspective. Eur Heart J. 2015 May 14;36(19):1163-70. doi: 10.1093/eurheartj/ehu505. Epub 2015 Jan 13.'}, {'pmid': '20805624', 'type': 'BACKGROUND', 'citation': "Bhatt DL, Eagle KA, Ohman EM, Hirsch AT, Goto S, Mahoney EM, Wilson PW, Alberts MJ, D'Agostino R, Liau CS, Mas JL, Rother J, Smith SC Jr, Salette G, Contant CF, Massaro JM, Steg PG; REACH Registry Investigators. Comparative determinants of 4-year cardiovascular event rates in stable outpatients at risk of or with atherothrombosis. JAMA. 2010 Sep 22;304(12):1350-7. doi: 10.1001/jama.2010.1322. Epub 2010 Aug 30."}, {'pmid': '15187054', 'type': 'BACKGROUND', 'citation': 'Eagle KA, Lim MJ, Dabbous OH, Pieper KS, Goldberg RJ, Van de Werf F, Goodman SG, Granger CB, Steg PG, Gore JM, Budaj A, Avezum A, Flather MD, Fox KA; GRACE Investigators. A validated prediction model for all forms of acute coronary syndrome: estimating the risk of 6-month postdischarge death in an international registry. JAMA. 2004 Jun 9;291(22):2727-33. doi: 10.1001/jama.291.22.2727.'}, {'pmid': '25343586', 'type': 'BACKGROUND', 'citation': 'Chua SK, Lo HM, Chiu CZ, Shyu KG. Use of CHADS(2) and CHA(2)DS(2)-VASc scores to predict subsequent myocardial infarction, stroke, and death in patients with acute coronary syndrome: data from Taiwan acute coronary syndrome full spectrum registry. PLoS One. 2014 Oct 24;9(10):e111167. doi: 10.1371/journal.pone.0111167. eCollection 2014.'}, {'pmid': '29760234', 'type': 'BACKGROUND', 'citation': 'Halcox JPJ, Wareham K. Response by Halcox and Wareham to Letter Regarding Article, "Assessment of Remote Heart Rhythm Sampling Using the AliveCor Heart Monitor to Screen for Atrial Fibrillation: The REHEARSE-AF Study". Circulation. 2018 May 15;137(20):2193-2194. doi: 10.1161/CIRCULATIONAHA.118.033773. No abstract available.'}, {'pmid': '40901364', 'type': 'DERIVED', 'citation': 'De La Torre Hernandez JM, Exposito V, Gonzalez Enriquez S, Rodriguez Entem F, Margarida A, Garcia Camarero T, Veiga G, Sainz Laso F, Lee DH, Gil Ongay A, Barrera S, Catoya S, Garilleti C, Hernandez R, Obregon C, Olalla JJ. Evaluation of ambulatory electrocardiographic monitoring of patients after high-risk acute coronary syndrome: the MONITOR ACS-Epic 13 randomized trial. Front Cardiovasc Med. 2025 Aug 18;12:1646175. doi: 10.3389/fcvm.2025.1646175. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the efficacy of monitoring after discharge of patients with high-risk acute coronary syndrome.', 'detailedDescription': 'The objective of the study is to evaluate the efficacy of monitoring after discharge of patients with high-risk acute coronary syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is able to understand the nature of study and has provided written informed consent.\n* Patient with Acute Coronary Syndrome, with or without elevation of the ST segment at the EKG (the last with elevation of troponins).\n* Patient with coronariography at the episode of ACS showing severe lesions treated with stent.\n* Patient with risk index for 6-month mortality (GRACE score) of more than 118.\n* Patient with risk index for stroke (CHA2DS2-VACS score) of more than 2.\n\nExclusion Criteria:\n\n* Patient with history of AF.\n* Patient with episodes of AF during admission at the current episode.\n* Patient with pacemaker or ICD (implantable cardioverter-defibrillator) previously.\n* Patient with indication of pacemaker or ICD in current or short-term phase.\n* Patient is participating in another interventional clinical investigation.\n* Patient is pregnant or breast feeding.\n* Patient´s life-expectancy is less than 24 months.'}, 'identificationModule': {'nctId': 'NCT03940066', 'acronym': 'Monitor- ACS', 'briefTitle': 'Evaluation of Ambulatory Monitoring of Patients After High-risk Acute Coronary Syndrome Using Two Different Systems: Biomonitor-2 and Kardia Mobile', 'organization': {'class': 'OTHER', 'fullName': 'Fundación EPIC'}, 'officialTitle': 'Evaluation of Ambulatory Monitoring of Patients After High-risk Acute Coronary Syndrome Using Two Different Systems: Biomonitor-2 and Kardia Mobile', 'orgStudyIdInfo': {'id': 'Monitor- ACS - EPIC 013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Monitoring group', 'interventionNames': ['Device: Biomonitor-2 and Kardia mobile']}, {'type': 'OTHER', 'label': 'Standard Care', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'Biomonitor-2 and Kardia mobile', 'type': 'DEVICE', 'description': 'Implantable cardiac monitor and Smart-phone based electrocardiogram recording', 'armGroupLabels': ['Monitoring group']}, {'name': 'No Intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39008', 'city': 'Santander', 'country': 'Spain', 'facility': 'Hospital Universitario Marques de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}], 'overallOfficials': [{'name': 'Felipe Rodríguez Entem, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Marqués de Valdecilla'}, {'name': 'José M De la Torre Hernández, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Marqués de Valdecilla'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación EPIC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}