Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT05485532
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-21
First Post:
2022-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development and Validation of a Telemonitoring System for High-risk Cardiovascular Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2022-07-21', 'studyFirstSubmitQcDate': '2022-08-02', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cardiac Autonomic Function', 'timeFrame': 'from inclusion to end of study (max. 3 years)', 'description': 'Heart Rate Variability (HRV), Deceleration Capacity (DC), Periodic Repolarization Dynamics (PRD), Baroreflex Sensitivity, ...'}], 'primaryOutcomes': [{'measure': 'occurence of combination of cardiovascular mortality, stroke, myocardial infarction and hospitalization due to decompensated heart failure', 'timeFrame': 'from inclusion to end of study (max. 3 years)'}], 'secondaryOutcomes': [{'measure': 'occurence of all cause mortality', 'timeFrame': 'from inclusion to end of study (max. 3 years)'}, {'measure': 'occurence of cardiovascular mortality', 'timeFrame': 'from inclusion to end of study (max. 3 years)'}, {'measure': 'occurence of stroke', 'timeFrame': 'from inclusion to end of study (max. 3 years)'}, {'measure': 'occurence of myocardial infarction', 'timeFrame': 'from inclusion to end of study (max. 3 years)'}, {'measure': 'number of patients with hospitalization due to decompensated heart failure', 'timeFrame': 'from inclusion to end of study (max. 3 years)'}, {'measure': 'number of patients with hospitalization due to other cardiovascular condition', 'timeFrame': 'from inclusion to end of study (max. 3 years)'}, {'measure': 'number of patients admitted to intensive care unit', 'timeFrame': 'from inclusion to end of study (max. 3 years)'}, {'measure': 'number of days with successful telemonitoring', 'timeFrame': 'from inclusion to end of study (max. 3 years)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'Development and validation of a telemonitoring system for high-risk cardiovascular patients.\n\nThe main purpose of this study is to investigate the beneficial effect of continuous telemonitoring in patients with cardiovascular diseases in different clinical settings (hospitalized patients, ambulant patients, patients during cardiac rehabilitation,...) Beside established risk parameters such as HRV (heart rate variability) and DC (Deceleration Capacity) new risk stratification models should be established from the continuously recorded biosignals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with presence of inclusion criteria presenting at one of the participating centres.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* decidable male and female patients \\> 18 years of age\n* cardiovascular disease with at least one of the following criteria:\n* LVEF ≤ 40%\n* cardiac autonomic dysfunction\n* St. p. myocardial infarction\n* St. p. cardiopulmonary resuscitation\n* St. p. pulmonalartery embolism\n* St. p. decompensated heart failure\n* Informed consent for participation in the clinical trial\n\nExclusion Criteria:\n\n* missing informed consent\n* pregnant and breast-feeding women'}, 'identificationModule': {'nctId': 'NCT05485532', 'acronym': 'TELE-CARDIO', 'briefTitle': 'Development and Validation of a Telemonitoring System for High-risk Cardiovascular Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'officialTitle': 'Development and Validation of a Telemonitoring System for High-risk Cardiovascular Patients', 'orgStudyIdInfo': {'id': '1282/2020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Telemonitoring System using Cosinuss° Two and/or Garmin Vivoactive 4', 'type': 'DEVICE', 'description': 'Development and validation of a telemonitoring system using smart devices'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'country': 'Austria', 'facility': 'Medizinische Universität Innsbruck, Univ.-Klinik für Innere Medizin III, Kardiologie und Angiologie', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '6232', 'city': 'Münster', 'state': 'Tyrol', 'country': 'Austria', 'facility': 'Reha Zentrum Münster', 'geoPoint': {'lat': 47.42164, 'lon': 11.83356}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Department for Internal Medicine III - Cardiology and Angiology', 'investigatorFullName': 'Univ. Prof. Dr. Axel Bauer', 'investigatorAffiliation': 'Medical University Innsbruck'}}}}