Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-01-18 @ 4:59 AM
Study NCT ID:
NCT04558450
Status:
RECRUITING
Last Update Posted:
2021-11-22
First Post:
2020-08-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Covid-19 Effects on Arterial Stiffness and Vascular Aging (CARTESIAN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000080909', 'term': 'Carotid-Femoral Pulse Wave Velocity'}], 'ancestors': [{'id': 'D063177', 'term': 'Pulse Wave Analysis'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective cohort study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2033-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-15', 'studyFirstSubmitDate': '2020-08-31', 'studyFirstSubmitQcDate': '2020-09-21', 'lastUpdatePostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'total mortality', 'timeFrame': '2 years', 'description': 'individual data will be meta-analyzed with sister studies running in parallel worldwide'}, {'measure': 'total mortality', 'timeFrame': '5 years', 'description': 'individual data will be meta-analyzed with sister studies running in parallel worldwide'}, {'measure': 'total mortality', 'timeFrame': '10 years', 'description': 'individual data will be meta-analyzed with sister studies running in parallel worldwide'}, {'measure': 'CV events', 'timeFrame': '2 years', 'description': 'fatal+non-fatal'}, {'measure': 'CV events', 'timeFrame': '5 years', 'description': 'fatal+non-fatal'}, {'measure': 'CV events', 'timeFrame': '10 years', 'description': 'fatal+non-fatal'}], 'primaryOutcomes': [{'measure': 'PWV', 'timeFrame': '6 months after COVID19 infection', 'description': 'carotid-femoral pulse wave velocity measured by application tonometry'}, {'measure': 'PWV', 'timeFrame': '12 months after COVID19 infection', 'description': 'carotid-femoral pulse wave velocity measured by application tonometry'}, {'measure': 'PWV change', 'timeFrame': 'difference between PWV at 12 and 6 months after COVID19 infection', 'description': 'carotid-femoral pulse wave velocity measured by application tonometry'}], 'secondaryOutcomes': [{'measure': 'arterial distensibility', 'timeFrame': '6 months after COVID19 infection', 'description': 'carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound'}, {'measure': 'arterial distensibility', 'timeFrame': '12 months after COVID19 infection', 'description': 'carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound'}, {'measure': 'arterial distensibility change', 'timeFrame': 'difference between arterial distensibility at 12 and 6 months after COVID19 infection', 'description': 'carotid, radial and digital distensibility by standard and ultrahigh frequency ultrasound'}, {'measure': 'brachial artery FMD', 'timeFrame': '6 months after COVID19 infection', 'description': 'brachial artery flow-mediated dilation for non-invasive evaluation of endothelial dysfunction, by ultrasound and automatic edge detection analysis'}, {'measure': 'brachial artery FMD', 'timeFrame': '12 months after COVID19 infection', 'description': 'brachial artery flow-mediated dilation for non-invasive evaluation of endothelial dysfunction, by ultrasound and automatic edge detection analysis'}, {'measure': 'brachial artery FMD change', 'timeFrame': 'difference between FMD at 12 and 6 months after COVID19 infection', 'description': 'brachial artery flow-mediated dilation for non-invasive evaluation of endothelial dysfunction, by ultrasound and automatic edge detection analysis'}, {'measure': 'central blood pressure', 'timeFrame': '6 months after COVID19 infection', 'description': 'central blood pressure obtained non-invasively by application tonometry and validated transfer function'}, {'measure': 'central blood pressure', 'timeFrame': '12 months after COVID19 infection', 'description': 'central blood pressure obtained non-invasively by application tonometry and validated transfer function'}, {'measure': 'central blood pressure (BP) change', 'timeFrame': 'difference between central BP at 12 and 6 months after COVID19 infection', 'description': 'central blood pressure obtained non-invasively by application tonometry and validated transfer function'}, {'measure': 'wave separation/wave intensity analysis (WSA/WIA)', 'timeFrame': '6 months after COVID19 infection', 'description': 'peripheral arterial waveform analysis aimed at exploring wave reflection and micro-macrocirculation crosstalk'}, {'measure': 'wave separation/wave intensity analysis (WSA/WIA)', 'timeFrame': '12 months after COVID19 infection', 'description': 'peripheral arterial waveform analysis aimed at exploring wave reflection and micro-macrocirculation crosstalk'}, {'measure': 'WSA/WIA change', 'timeFrame': 'difference between WSA/WIA at 12 and 6 months after COVID19 infection', 'description': 'peripheral arterial waveform analysis aimed at exploring wave reflection and micro-macrocirculation crosstalk'}, {'measure': 'cardiac diastolic dysfunction', 'timeFrame': '6 months after COVID19 infection', 'description': "E/e' at rest and after low-level exercise"}, {'measure': 'cardiac diastolic dysfunction', 'timeFrame': '12 months after COVID19 infection', 'description': "E/e' at rest and after low-level exercise"}, {'measure': 'cardiac diastolic dysfunction change', 'timeFrame': 'difference between cardiac diastolic dysfunction at 12 and 6 months after COVID19 infection', 'description': "E/e' at rest and after low-level exercise"}, {'measure': 'myocardial stiffness', 'timeFrame': '6 months after COVID19 infection', 'description': 'cardioelastography by ultrafast ultrasound'}, {'measure': 'myocardial stiffness', 'timeFrame': '12 months after COVID19 infection', 'description': 'cardioelastography by ultrafast ultrasound'}, {'measure': 'myocardial stiffness change', 'timeFrame': 'difference between myocardial stiffness at 12 and 6 months after COVID19 infection', 'description': 'cardioelastography by ultrafast ultrasound'}, {'measure': 'carotid femoral and hearth carotid change', 'timeFrame': '6 months after COVID19 infection', 'description': 'Mesure by laser doppler vibrometry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'Arterial Stiffness', 'Endothelial Dysfunction', 'Diastolic Dysfunction']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.arterysociety.org/our-activities-2/cartesian-2/', 'label': 'general description of the study'}, {'url': 'http://vascagenet.eu/successful-information-session-on-the-cartesian-study', 'label': 'summary and presentation of the global CARTESIAN initiative'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the presence of early vascular aging 6 months and 12 months after COVID-19 infection.', 'detailedDescription': 'After being informed about the study and potential risks, all eligible patients giving written informed consent will undergo a comprehensive non-invasive assessment of vascular and cardiac function 6 months and 12 months after COVID-19 infection. Cardiovascular events and mortality will be collected 2, 5 and 10 years after inclusion'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>18 years, both sexes;\n* written informed consent;\n* affiliation to a social security regime;\n* a recent diagnosis of COVID19 (6±3 months) proven by PCR or serology (for group 1,2,3)\n* hospitalization in intensive care unit for COVID19 (for group 1)\n* hospitalization in a medicine unit for COVID19 (for group 2)\n* no hospitalization for COVID19 or hospitalization less than 24h (for group 3)\n* a negative test for SARS-nCOV2 infection (PCR or serology)(for group 4)\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Inability to express consent of the study\n* Diseases carrying out a life -expectancy \\<1 year according to clinical judgment\n* Pregnancy and breastfeeding\n* Foreseen inability to attend scheduled visits'}, 'identificationModule': {'nctId': 'NCT04558450', 'acronym': 'CARTESIAN', 'briefTitle': 'Covid-19 Effects on Arterial Stiffness and Vascular Aging (CARTESIAN)', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Covid-19 Effects on ARTErial StIffness and Vascular AgiNg', 'orgStudyIdInfo': {'id': 'APHP200762'}, 'secondaryIdInfos': [{'id': 'APHP200762', 'type': 'OTHER', 'domain': 'ANSM'}, {'id': '20.07.24.57438', 'type': 'OTHER', 'domain': 'CNRIPH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group 1', 'description': 'Patients with confirmed infection by SARS-Cov-2, requiring a hospitalization in intensive care unit', 'interventionNames': ['Diagnostic Test: carotid-femoral pulse-wave velocity']}, {'type': 'OTHER', 'label': 'Group 2', 'description': 'Patients with confirmed infection by SARS-Cov-2, requiring a hospitalization in a medicine unit', 'interventionNames': ['Diagnostic Test: carotid-femoral pulse-wave velocity']}, {'type': 'OTHER', 'label': 'Group 3', 'description': 'Patients with confirmed infection by SARS-Cov-2, not requiring hospitalization', 'interventionNames': ['Diagnostic Test: carotid-femoral pulse-wave velocity']}, {'type': 'OTHER', 'label': 'Group 4', 'description': '4\\) individuals having performed a test for SARS-Cov-2 infection, but resulted to be negative', 'interventionNames': ['Diagnostic Test: carotid-femoral pulse-wave velocity']}], 'interventions': [{'name': 'carotid-femoral pulse-wave velocity', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['arterial distensibility', 'wave separation/intensity analysis', 'flow-mediated dilation', 'cardiac diastolic dysfunction', 'myocardial stiffness', 'central blood pressure'], 'description': 'early vascular aging tests', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Athanase BENETOS, PhD', 'role': 'CONTACT', 'email': 'a.benetos@chru-nancy.fr', 'phone': '+ 33 3 83 15 33 22'}], 'facility': 'CHRU Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '75015', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre BOUTOUYRIE, PUPH', 'role': 'CONTACT', 'email': 'Pierre.boutouyrie@aphp.fr', 'phone': '+33 1 56 09 39 91'}], 'facility': 'Hôpital Européen Georges Pompidou - APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '76031', 'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jérémy BELLIEN, PUPH', 'role': 'CONTACT', 'email': 'jeremy.bellien@chu.rouen.fr', 'phone': '+33 2 32 88 14 28'}], 'facility': 'CHU Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'centralContacts': [{'name': 'Rosa Maria BRUNO, MD', 'role': 'CONTACT', 'email': 'rosa-maria.bruno@inserm.fr', 'phone': '+33 1 53 98 79 67'}, {'name': 'Laura LE MAO, MSc', 'role': 'CONTACT', 'email': 'laura.le-mao@aphp.fr', 'phone': '+33 1 56 09 54 97'}], 'overallOfficials': [{'name': 'Pierre BOUTOUYRIE, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'One year after the last publication', 'ipdSharing': 'YES', 'description': 'Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared', 'accessCriteria': 'Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team. The founder could be involved in the decision.\n\nTeams wishing obtain IPD must meet the sponsor and PI team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Association for Research into Arterial Structure and Physiology', 'class': 'UNKNOWN'}, {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}