Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT06960902
Status:
RECRUITING
Last Update Posted:
2025-10-03
First Post:
2025-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia (ATHERO-FH Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pathophysiology study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-09-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-04-29', 'studyFirstSubmitQcDate': '2025-04-29', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of subclinical coronary atherosclerosis', 'timeFrame': 'At the time of performing the coronary CT scan', 'description': 'The criterion defining the presence of subclinical coronary atherosclerosis is the presence of at least one coronary stenosis greater than 50% in a main artery on coronary CT angiography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Familial hypercholesterolemia', 'atherosclerotic cardiovascular disease'], 'conditions': ['Familial Hypercholesterolemias', 'Atherosclerotic Cardiovascular Disease (ASCVD)']}, 'descriptionModule': {'briefSummary': 'The goal of this study (interventional clinical research not involving a health product) is to assess the prevalence of subclinical coronary atherosclerosis diagnosed by coronary CT angiography in heart failure patients in primary prevention, across different levels of cardiovascular risk defined by coronary artery calcium (CAC) score percentiles (based on data from the MESA study): low risk (≤25th percentile for age, sex, and ethnicity), intermediate risk (25th \\< CAC ≤ 75th percentile), and high risk (\\>75th percentile). The Patients will attend an on-site visit at inclusion (and must undergo a coronary CT angiography within 6 months following this visit), will be contacted by phone at 1 year and 2 years, and will return for an on-site visit at 30 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Person willing to sign the study consent form\n* Person affiliated with a current social security scheme\n* Person with a definite diagnosis of Familial Hypercholesterolemia, defined by a Dutch Lipid Clinic Network (DLCN) clinical-biological score \\> 8 and/or an identified causal mutation in the LDL receptor (LDLR) gene, apolipoprotein B100 gene, PCSK9 gene, or apolipoprotein E gene\n* Male aged 40 years or older, or female aged 50 years or older\n* Ability to understand French for questionnaire completion\n* Person not taking any lipid-lowering medication or on a stable dose of lipid-lowering therapy for at least one month prior to inclusion (three months for PCSK9 inhibitors) at Visit 1\n* Person not taking any antihypertensive medication or on a stable dose of antihypertensive therapy for at least one month at Visit 1\n* Person not taking any antidiabetic medication or on a stable dose of antidiabetic therapy for at least 3 months at Visit 1\n\nExclusion Criteria:\n\n* Subject with a technical contraindication for coronary CT scan: patient diameter \\> 70 cm and/or weight \\> 250 kg\n* Patient with a history of atherosclerotic cardiovascular event (myocardial infarction, ischemic heart disease, coronary revascularization, ischemic stroke, carotid endarterectomy, lower limb arterial revascularization)\n* Patient allergic to iodinated contrast agents\n* Severe renal insufficiency: estimated glomerular filtration rate (eGFR) according to the CKD-EPI formula ≤ 30 ml/min\n* Subject with active cancer or in remission for less than 3 years\n* Subject who has received oral or intravenous corticosteroid therapy within the last 6 months\n* Subject with untreated or poorly controlled hypothyroidism\n* Subject receiving immunosuppressive or anticancer therapy\n* Subject refusing to participate\n* Subject under guardianship, curatorship, or judicial protection, or without social insurance coverage\n* Pregnant woman'}, 'identificationModule': {'nctId': 'NCT06960902', 'acronym': 'ATHERO-FH', 'briefTitle': 'Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia (ATHERO-FH Study)', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia', 'orgStudyIdInfo': {'id': 'RC24_0343'}, 'secondaryIdInfos': [{'id': '2025-A00453-46', 'type': 'REGISTRY', 'domain': 'National number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single arm', 'description': 'Visit 1: Inclusion Visit: Verification of eligibility criteria. Consent form signing, collection of clinical information, and completion of questionnaires. Fasting blood draw for biological analyses and biobanking. Collection of urine and stool samples (optional). POpmeter (optional), Fibroscan (optional), completion of the CONSTANCES and SF36 questionnaires.\n\nVisit 2 (30 months): Collection of the CAC score result (dated less than 6 months prior). Collection of clinical information and completion of questionnaires. Fasting blood draw for biological analyses and biobanking. Collection of urine and stool samples (optional). pOpmeter (optional), Fibroscan (optional), completion of the CONSTANCES and SF36 questionnaires.\n\nMajor cardiovascular events will be collected from patients during telephone calls at 1 and 2 years, and during the 30-month visit.', 'interventionNames': ['Other: Coronary CT scan with CAC score measurement']}], 'interventions': [{'name': 'Coronary CT scan with CAC score measurement', 'type': 'OTHER', 'description': 'Coronary CT scan with CAC score measurement (on the same day or within 6 months after the inclusion visit).', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dijon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yves COTTIN', 'role': 'CONTACT', 'email': 'yves.cottin@chu-dijon.fr', 'phone': '+33 3 80 29 35 36'}, {'name': 'Yves COTTIN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Lille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cécile YELNIK', 'role': 'CONTACT', 'email': 'cecile.yelnik@chu-lille.fr', 'phone': '+33 3 20 44 59 62'}, {'name': 'Cecile YELNIK', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHRU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sybil CHARRIERE', 'role': 'CONTACT', 'email': 'sybil.charriere@chu-lyon.fr', 'phone': '+33 4 27 85 66 66'}, {'name': 'Sybil CHARRIERE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sophie BELIARD-LASSERRE', 'role': 'CONTACT', 'email': 'Sophie.beliard@ap-hm.fr', 'phone': '+33 4 91 38 36 50'}, {'name': 'Sophie BELIARD-LASSERRE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital de la Conception, AP-HM', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bertrand CARIOU, Pr', 'role': 'CONTACT', 'email': 'bertrand.cariou@chu-nantes.fr', 'phone': '+33 2 53 48 27 10'}, {'name': 'Bertrand CARIOU CARIOU', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Antonio GALLO', 'role': 'CONTACT', 'email': 'Antonio.gallo@aphp.fr', 'phone': '+33 1 42 17 57 85'}, {'name': 'Antonio GALLO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital de la Pitié-Salpêtrière, AP-HP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Franck BOCCARA', 'role': 'CONTACT', 'email': 'franck.boccara@aphp.fr', 'phone': '+33 1 49 28 24 49'}, {'name': 'Franck BOCCARA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Saint-Antoine, AP-HP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Rennes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'François PAILLARD', 'role': 'CONTACT', 'email': 'francois.paillard@chu-rennes.fr', 'phone': '+33 2 99 28 25 40'}, {'name': 'François PAILLARD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Strasbourg', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alain PRADIGNAC', 'role': 'CONTACT', 'email': 'alain.pradignac@chru-strasbourg.fr', 'phone': '+33 3 88 12 75 89'}, {'name': 'Alain PRADIGNAC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Bertrand CARIOU, Pr', 'role': 'CONTACT', 'email': 'bertrand.cariou@chu-nantes.fr', 'phone': '+33 2 53 48 27 10'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'France 2030 program', 'class': 'UNKNOWN'}, {'name': 'European Union Next Generation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}