Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-25 @ 7:21 PM
Study NCT ID:
NCT04205032
Status:
COMPLETED
Last Update Posted:
2021-07-28
First Post:
2019-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation in Healthy Volunteers of CARDIOSPACE II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-21', 'studyFirstSubmitDate': '2019-12-11', 'studyFirstSubmitQcDate': '2019-12-18', 'lastUpdatePostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of the ECG signal given by CARDIOSPACE II: scale', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'ECG signal will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise'}, {'measure': 'Quality of the vascular Doppler signal: scale', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Doppler signal will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise'}, {'measure': 'Quality of the laser doppler signal: scale', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Laser Doppler signal will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise'}, {'measure': 'Quality of the ultrasound images: scale', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Ultrasound images will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable image and 5 is a very clear image'}, {'measure': 'Quality of the blood pressure wave: scale', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Blood pressure wave signal will be estimated by by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise'}, {'measure': 'Quality of the ambulatory measurements (ECG / SAO2)', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'ECG and SaO2 ambulatory measurements will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The aim of this project is to test the CARDIOSPACE II system that integrates several medical devices. This system is dedicated to physiological studies in space environment.\n\n* Electrocardiogram\n* Vascular doppler\n* Laser doppler with iontophoresis\n* Continuous blood pressure recording at the finger level\n* Brachial blood pressure\n* Ultrasound\n* Ambulatory Electrocardiogram and SAO2 (arterial oxygen saturation) recorder'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Height between 160 et 180 cm\n* Body mass index between 18 et 24\n* Normal blood pressure, heart rate and cardio-pulmonary auscultation at rest\n* Normal electrocardiogram\n* Possibility to perform transcranial doppler\n* Able to understand aims and constraints of this study\n* National health insurance\n* Signature of the informed consent form\n\nExclusion Criteria:\n\n* Pregnant woman (Beta HCG - human chorionic gonadotropin - with urinary test) or breastfeeding\n* Participating at the time to another clinical trial investigating\n* Reached or surpassed the annual amount of financial compensation allowed by clinical trials (according to French regulation)\n* Taking any chronic treatment\n* Any sign of cardiovascular or respiration disease\n* Any sign of syncopal events by questioning (\\>2 events per year)\n* Contraindication to perform physical activity'}, 'identificationModule': {'nctId': 'NCT04205032', 'acronym': 'CDSII', 'briefTitle': 'Evaluation in Healthy Volunteers of CARDIOSPACE II', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Evaluation in Healthy Volunteers of CARDIOSPACE II for Physiological Studies in Space', 'orgStudyIdInfo': {'id': 'IRCB:2019-AO1519-48'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CARDIOSPACE II', 'description': 'Test of the different devices integrated in cardiospace II.', 'interventionNames': ['Device: Test of the different devices integrated in cardiospace II']}], 'interventions': [{'name': 'Test of the different devices integrated in cardiospace II', 'type': 'DEVICE', 'description': 'The different devices included in CARDIOSPACE II will be tested\n\n* Electrocardiogram\n* Vascular Doppler\n* LaserDoppler and iontophoresis\n* Brachial blood pressure\n* Continuous blood pressure recorded at the finger level\n* Ultrasound\n* Ambulatory Electrocardiogram / SAO2 (arterial oxygen saturation)', 'armGroupLabels': ['CARDIOSPACE II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49000', 'city': 'Angers', 'state': 'Maine Et Loire', 'country': 'France', 'facility': "CHU d'Angers, Clinical Research Center", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Centre National des Etudes Spatiales - French Space Agency (CNES)', 'class': 'UNKNOWN'}, {'name': 'Astronautic Center of China (ACC)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}