Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-02-24 @ 5:03 PM
Study NCT ID:
NCT03107351
Status:
COMPLETED
Last Update Posted:
2018-02-09
First Post:
2017-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Linear and Torsional Contractility Measurements With a New Technology: Multi Dimensional Kineticardiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Double blind randomized crossover active vs placebo'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-07', 'studyFirstSubmitDate': '2017-02-22', 'studyFirstSubmitQcDate': '2017-04-04', 'lastUpdatePostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HK reproducibility validation', 'timeFrame': 'day 1', 'description': 'Validate the reproducibility of HK measurements in a clinical environment.'}, {'measure': 'Cardiac contractility tracking with HK', 'timeFrame': 'day 1', 'description': 'Proof that the HK technology can track physiological cardiac changes while comparing with gold standard echocardiography and inducing a cardiac contractility change with dobutamine infusion.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '33407507', 'type': 'DERIVED', 'citation': 'Hossein A, Rabineau J, Gorlier D, Pinki F, van de Borne P, Nonclercq A, Migeotte PF. Effects of acquisition device, sampling rate, and record length on kinocardiography during position-induced haemodynamic changes. Biomed Eng Online. 2021 Jan 6;20(1):3. doi: 10.1186/s12938-020-00837-5.'}]}, 'descriptionModule': {'briefSummary': "This study aims to validate the possibility to track cardiac contractility changes with a new technology called 'Heart Kinetic' (HK). HK measurements will be realized and compared echocardiography."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult between 18 and 50 years old.\n* Healthy without medical cardiac conditions history.\n* Non smoker.\n* Does not take any drugs or medications.\n* Does not participate in other clinical study or trial.\n* BMI (Body Mass Index) in between 20 and 25 kg/m2.\n\nExclusion Criteria:\n\n* Being younger than 18 or older than 50 years old.\n* Having had previous cardiac conditions or present disease.\n* Being a regular smoker.\n* Taking any drugs or medications\n* Taking part in another clinical study or trial.\n* BMI (Body Mass Index) lower than 20 or higher than 25 kg/m2.'}, 'identificationModule': {'nctId': 'NCT03107351', 'acronym': 'MultiKinVal', 'briefTitle': 'Cardiac Linear and Torsional Contractility Measurements With a New Technology: Multi Dimensional Kineticardiography', 'organization': {'class': 'OTHER', 'fullName': 'Erasme University Hospital'}, 'officialTitle': 'Validation Study of Cardiac Linear and Torsional Contractility Measurements With a New Technology: Multi Dimensional Kineticardiography (MKCG)', 'orgStudyIdInfo': {'id': 'P2016/474'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'repeatability measures', 'description': 'In this arm, healthy subjects will undergo repeated measures at different times of the day.', 'interventionNames': ['Device: Cardiac assessment repeatability with Kino-cardiograph']}, {'type': 'EXPERIMENTAL', 'label': 'Contractility changes measures', 'description': 'In this arm, healthy subjects will have their cardiac contractility increased in a controlled way and assessed with both HK and echocardiography.', 'interventionNames': ['Device: Cardiac contractility assessments with Kino-cardiograph']}], 'interventions': [{'name': 'Cardiac contractility assessments with Kino-cardiograph', 'type': 'DEVICE', 'description': 'Cardiac contractility will be assessed with Kino-cardiograph device. Echocardiography will also be used for the experimental arm', 'armGroupLabels': ['Contractility changes measures']}, {'name': 'Cardiac assessment repeatability with Kino-cardiograph', 'type': 'DEVICE', 'description': 'Cardiac contractility will be assessed with Kino-cardiograph device only, at different times of the day to assess the repeatability of the measures.', 'armGroupLabels': ['repeatability measures']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Brussels', 'state': 'Anderlecht', 'country': 'Belgium', 'facility': 'Hôpital Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasme University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Philippe Van de Borne', 'investigatorAffiliation': 'Erasme University Hospital'}}}}