Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-02-13 @ 3:44 PM
Study NCT ID:
NCT02961868
Status:
COMPLETED
Last Update Posted:
2019-09-23
First Post:
2016-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cohort Follow-up of Patients With Renal or Craniocervical Fibromuscular Dysplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005352', 'term': 'Fibromuscular Dysplasia'}, {'id': 'D012078', 'term': 'Renal Artery Obstruction'}, {'id': 'D002340', 'term': 'Carotid Artery Diseases'}], 'ancestors': [{'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D015415', 'term': 'Biomarkers'}], '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'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 340}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-20', 'studyFirstSubmitDate': '2016-11-07', 'studyFirstSubmitQcDate': '2016-11-10', 'lastUpdatePostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression of fibromuscular dysplasia lesions confirmed by imaging', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Glomerular filtration rate (GFR)', 'timeFrame': 'Inclusion, 3 years'}, {'measure': 'Kidney height', 'timeFrame': 'Inclusion, 3 years'}, {'measure': 'Clinical event: revascularization procedure in a lesion site', 'timeFrame': 'Through study completion'}, {'measure': 'Clinical event: renal infarction', 'timeFrame': 'Through study completion'}, {'measure': 'Clinical event: ischemic stroke', 'timeFrame': 'Through study completion'}, {'measure': 'Clinical event: arterial dissection in a lesion site or downstream from a lesion site', 'timeFrame': 'Through study completion'}, {'measure': 'Clinical event: aneurysm rupture in a lesion site or downstream from a lesion site', 'timeFrame': 'Through study completion'}, {'measure': 'Prevalence of multisite fibromuscular dysplasia confirmed by imaging', 'timeFrame': 'Inclusion, 3 years'}, {'measure': 'Single nucleotide polymorphisms', 'timeFrame': 'Inclusion', 'description': 'Assessed by genome-wide association'}, {'measure': 'Plasminogen/plasmin level', 'timeFrame': 'Inclusion'}, {'measure': 'Matrix metalloproteinases level', 'timeFrame': 'Inclusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Renal Artery Obstruction', 'Carotid Artery Diseases', 'Genetic Association Studies'], 'conditions': ['Fibromuscular Dysplasia']}, 'descriptionModule': {'briefSummary': 'PROFILE is a cohort study evaluating the progression of fibromuscular dysplasia lesions. This study is the prospective dimension of ARCADIA registry (ClinicalTrials.gov Identifier: NCT02884141), which aims to document phenotypic and genetic traits in patients with renal and/or cervical artery fibromuscular dysplasia.', 'detailedDescription': "Background\n\nFibromuscular dysplasia (FMD) is a group of nonatherosclerotic, noninflammatory arterial diseases that usually involve renal and carotid arteries. Patients with FMD may present with renovascular hypertension and/or with cerebrovascular symptoms. The prevalence of FMD in hypertensive patients is estimated at 4/1000. Angiographic classification includes the multifocal type, with multiple stenoses and the 'string-of-beads' appearance that is related to medial FMD, and tubular and focal types which are not clearly related to specific histological lesions. FMD may affect one or more vascular beds and progress to more severe stenosis and to renal or cerebrovascular complications. FMD appears to be familial in 10% of cases (OMIM #135580).\n\nRenal artery FMD may progress to more severe stenosis and to renal atrophy, and/or to stenoses affecting more arteries within or outside the renal vasculature. The risk of progression as assessed from available studies was probably overestimated because documentation of progression was obtained from angiography, a procedure which is not routinely undertaken in patients with favourable clinical and biological outcomes. The disease is progressive, however, and literature stated that patients with FMD should undergo yearly duplex ultrasonography to detect progression of disease, restenosis, or loss of kidney volume.\n\nThere are very few data on prognosis of patients with symptomatic carotid or vertebral artery FMD. The risk of arterial disease progression over time is unknown. The risk of ischemic stroke ranged from 0 to about 3% per year in the few studies which assessed that issue.\n\nObjectives\n\nThe primary objective is to estimate the incidence and risk factors for progression of FMD lesions. This will be assessed by comparison between initial and 3 years abdominal and supra-aortic trunks vascular imaging (angiography, CT-angiography or Magnetic Resonance (MR) angiography), monitoring of downstream consequences development of lesions progression and clinical events.\n\nThe secondary objectives are:\n\n* to estimate rate of genetic polymorphism that may influence disease progression or be associated with complications\n* to assess the frequency of multi-site FMD (common objective with the ARCADIA study)\n* to collect standardized clinical, radiological, and biological data in patients with FMD through a national registry (common objective with the ARCADIA study)\n* to organize a clinical, radiological and biological database and a biobank that will constitute a unique resource to initiate further clinical research (common objective with the ARCADIA study)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with renal or craniocervical fibromuscular dysplasia diagnosed during the 2 years before inclusion\n* The fibromuscular dysplasia is documented by imaging (angiography, CT-angiography, MR-angiography) of less than 2 years and validated by a radiologist investigator\n* Patient who understood and signed inform consent form\n* Affiliated to the French health insurance system\n* Available for a 3 years follow-up\n\nExclusion Criteria:\n\n* Patient with renal or craniocervical atherosclerosis, or inflammatory vascular disease as dominant pathological features\n* Patient with renal or craniocervical arteries dissection or aneurysm without any other evidence of fibromuscular dysplasia\n* Patient under 18 or under tutorship\n* Known pregnancy'}, 'identificationModule': {'nctId': 'NCT02961868', 'acronym': 'PROFILE', 'briefTitle': 'Cohort Follow-up of Patients With Renal or Craniocervical Fibromuscular Dysplasia', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'PROgression of FIbromuscular LEsions', 'orgStudyIdInfo': {'id': 'P071241'}, 'secondaryIdInfos': [{'id': 'P071241', 'type': 'OTHER', 'domain': 'Assistance Publique - Hopitaux de Paris'}, {'id': '2009-A00288-49', 'type': 'OTHER', 'domain': 'Agence Française de Securite Sanitaire des Produits de Sante'}, {'id': 'PHRC-08-192', 'type': 'OTHER_GRANT', 'domain': "Direction Generale de l'Offre de Soin"}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prospective cohort', 'description': '3 years follow-up', 'interventionNames': ['Other: Abdominal and supra-aortic trunks vascular imaging', 'Genetic: Blood sampling (genetic)', 'Other: Blood sampling (biomarkers)', 'Other: Urine sampling']}], 'interventions': [{'name': 'Abdominal and supra-aortic trunks vascular imaging', 'type': 'OTHER', 'description': 'Abdominal and supra-aortic trunks vascular imaging (angiography, CT-angiography or MR-angiography) will be performed 3 years after inclusion. This imaging will be compare to initial imaging (which is a part of usual care, not an intervention added by the study) in order to assess FMD progression.', 'armGroupLabels': ['Prospective cohort']}, {'name': 'Blood sampling (genetic)', 'type': 'GENETIC', 'description': 'A sample of blood will be taken to meet the objective of estimating the rate of genetic polymorphism that may influence disease progression or be associated with complications.', 'armGroupLabels': ['Prospective cohort']}, {'name': 'Blood sampling (biomarkers)', 'type': 'OTHER', 'description': 'A sample of blood will be taken to biomarkers analysis to meet the primary objective of assessing the risk factors for progression of FMD lesions.', 'armGroupLabels': ['Prospective cohort']}, {'name': 'Urine sampling', 'type': 'OTHER', 'description': 'A sample of urine will be taken to biomarkers analysis to meet the primary objective of assessing the risk factors for progression of FMD lesions.', 'armGroupLabels': ['Prospective cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'Cliniques universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '33000', 'city': 'Bordeaux', 'state': 'Aquitaine-Limousin-Poitou-Charentes', 'country': 'France', 'facility': 'CHU de Bordeaux hopital Saint-Andre', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '63000', 'city': 'Clermont-Ferrand', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'CHU de Clermont-Ferrand hopital Gabriel-Montpied', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '38700', 'city': 'La Tronche', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'CHU de Grenoble hopital Albert-Michallon', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}, {'zip': '54500', 'city': 'Vandeuvre-les-Nancy', 'state': 'Grand Est', 'country': 'France', 'facility': 'CHU de Nancy institut Louis-Mathieu'}, {'zip': '59000', 'city': 'Lille', 'state': 'Hauts-de-France', 'country': 'France', 'facility': 'CHRU de Lille hopital cardiologique', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59000', 'city': 'Lille', 'state': 'Hauts-de-France', 'country': 'France', 'facility': 'CHRU de Lille hopital Roger-Salengro', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '14000', 'city': 'Caen', 'state': 'Normandy', 'country': 'France', 'facility': 'CHU de Caen hopital Cote de Nacre', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '31000', 'city': 'Toulouse', 'state': 'Occitanie', 'country': 'France', 'facility': 'CHU de Toulouse hopital Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '13385', 'city': 'Marseille', 'state': "Provence-Alpes-Côte d'Azur Region", 'country': 'France', 'facility': 'AP-HM hopital de la Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '78157', 'city': 'Le Chesnay', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Centre Hospitalier de Versailles hopital Andre Mignot', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}, {'zip': '75010', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'AP-HP hopital Lariboisiere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75013', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'AP-HP hopital Pitie-Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Centre hospitalier Sainte-Anne', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Groupe Hospitalier Paris Saint-Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75018', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'AP-HP hopital Bichat-Claude-Bernard', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75020', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'AP-HP hopital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Pierre-François Plouin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': "Fondation de Recherche sur l'Hypertension Artérielle", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}