Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-04-20 @ 5:02 PM
Study NCT ID:
NCT03064503
Status:
UNKNOWN
Last Update Posted:
2023-06-13
First Post:
2017-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myocardial Fibrosis, Function and Aging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-06-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-12', 'studyFirstSubmitDate': '2017-02-21', 'studyFirstSubmitQcDate': '2017-02-22', 'lastUpdatePostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Regional myocardial strain', 'timeFrame': 'The day of MRI', 'description': 'Segmental measures of systolic and diastolic strains with magnetic resonance imaging (MRI)'}], 'secondaryOutcomes': [{'measure': 'MRI T1 value', 'timeFrame': 'The day of MRI, before gadolinium injection', 'description': 'This value is an indicator of interstitial fibrosis and extracellular volume'}, {'measure': 'MRI T1 value', 'timeFrame': 'The day of MRI, 15 minutes after gadolinium injection', 'description': 'Diminution of this value after gadolinium injection is an indicator of increasing quantity of interstitial fibrosis and extracellular volume'}, {'measure': 'Apparent Diffusion Coefficient (ADC) with MRI', 'timeFrame': 'The day of MRI', 'description': 'ADC is measured with diffusion weighted imaging'}, {'measure': 'Blood carboxy-terminal propeptide of procollagen type I (PICP) rate', 'timeFrame': 'The day of MRI', 'description': 'Collagen blood biomarker analysis'}, {'measure': 'Blood amino-terminal propeptide of procollagen type III (PIIINP) rate', 'timeFrame': 'The day of MRI', 'description': 'Collagen blood biomarker analysis'}, {'measure': 'Advanced Glycation End-products (AGE) rate', 'timeFrame': 'The day of MRI', 'description': 'Skin auto-fluorescence AGE measures'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['myocardial fibrosis', 'cardiac function', 'ageing'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'In normal ageing, the impact of myocardial fibrosis on myocardial function is unclear as diastolic function is reported to change according to age. The objective is to explore the relationship between myocardial function changes, with local (T1 and diffusion) fibrosis measures with Magnetic Resonance Imaging (MRI) as well as global measures of fibrosis (skin auto-fluorescence and collagen blood-biomarkers).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* physical activity ≤ 3 x(30') per week\n* no history of smoking, diabetes, myocardial infarction, heart failure, hypertension (\\<140 or \\<90 mmHg) and no anti-hypertensive or cardiovascular-related medications\n* no familial history of early myocardial ischemia\n* body mass index (BMI) \\<30kg/m2\n* normal routine lipid blood analysis\n* glycemia \\<1.26g/l\n* normal electrocardiogram (ECG)\n\nExclusion Criteria:\n\n* arrhythmia\n* hepatic insufficiency\n* pregnancy\n* claustrophobia\n* MRI contrast allergy,\n* general contraindications to MRI such as pacemaker, etc."}, 'identificationModule': {'nctId': 'NCT03064503', 'acronym': 'MARVEL', 'briefTitle': 'Myocardial Fibrosis, Function and Aging', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Myocardial Fibrosis and Changes of Myocardial Function Related to Aging', 'orgStudyIdInfo': {'id': '69HCL15_0744'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy volunteers', 'description': 'Sedentary healthy subjects will be recruited in this study. MRI, skin auto-fluorescence measures and blood sampling will be performed', 'interventionNames': ['Biological: Blood sampling', 'Device: MRI', 'Biological: Skin auto-fluorescence']}], 'interventions': [{'name': 'Blood sampling', 'type': 'BIOLOGICAL', 'description': 'Blood sampling will be performed at inclusion to investigate some biological eligibility criteria, and the day of MRI in order to analyse fibrosis biomarkers and collagen synthesis biomarkers', 'armGroupLabels': ['Healthy volunteers']}, {'name': 'MRI', 'type': 'DEVICE', 'description': 'MRI will be performed to measure interstitial fibrosis', 'armGroupLabels': ['Healthy volunteers']}, {'name': 'Skin auto-fluorescence', 'type': 'BIOLOGICAL', 'description': 'Skin auto-fluorescence measures will be performed to measure advanced glycation end-products (AGE) produced by collagen degradation', 'armGroupLabels': ['Healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42270', 'city': 'Saint-Etienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre CROISILLE, MD, PhD', 'role': 'CONTACT', 'email': 'croisille@creatis.insa-lyon.fr', 'phone': '+33 477 127 584'}, {'name': 'Pierre CROISILLE, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Département de Radiologie, CHU Saint-Etienne - Hôpital Nord', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'centralContacts': [{'name': 'Pierre CROISILLE, MD, PhD', 'role': 'CONTACT', 'email': 'croisille@creatis.insa-lyon.fr', 'phone': '+33 477 127 584'}], 'overallOfficials': [{'name': 'Pierre CROISILLE, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}