Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT04774302
Status:
COMPLETED
Last Update Posted:
2025-06-10
First Post:
2021-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Correlation Between Hepatic Fibrosis and Cardiovascular Risk Evaluated by Non-invasive Tests in Patients With NAFLD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 292}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2021-02-24', 'studyFirstSubmitQcDate': '2021-02-24', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coronary calcium score', 'timeFrame': 'At inclusion', 'description': 'Score in Agatston IU of coronary atherosclerosis risk;ranging from 0 to 100 : low risk; 100 to 400 : intermediate risk and \\> 400 : high risk of coronary atherosclerosis.'}, {'measure': 'Shear wave liver elastography', 'timeFrame': 'At inclusion', 'description': 'Hepatic elasticity assessed in kPa : \\<5 Kpa : normal; 5 to 8 kPa : low to moderate fibrosis ; \\> 8 kPa : advanced fibrosis; \\>15 kPa : cirrhosis'}], 'secondaryOutcomes': [{'measure': 'ARFI Hepatic elasticity', 'timeFrame': 'At inclusion', 'description': 'Hepatic elasticity assessed by Acoustic radiation force impulse (ARFI) (in kPa) Hepatic elasticity assessed in kPa : \\<5 Kpa : normal; 5 to 8 kPa : low to moderate fibrosis ; \\> 8 kPa : advanced fibrosis; \\>15 kPa : cirrhosis .'}, {'measure': 'Cardiovascular risk', 'timeFrame': 'At inclusion', 'description': 'Systemic Coronary Risk Estimation (SCORE) ranging from \\<1% very low risk to \\>15% very high risk of cardiovascular mortality'}, {'measure': 'Coronary heart disease', 'timeFrame': '3 month', 'description': 'Diagnosis of coronary heart disease'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CAC score', 'Liver fibrosis', 'Cardiovascular risk', 'Metabolic syndrome'], 'conditions': ['NAFLD']}, 'descriptionModule': {'briefSummary': 'This study aims to examine the link between Non-Alcoholic Fatty Liver Disease (NAFLD) and cardiovascular diseases by studying the association between liver fibrosis degree and cardiovascular risk factors. The study would clarify the value and the role of the Coronary calcium score (CAC score) in the screening for coronary disease in this population at high cardiovascular risk.', 'detailedDescription': 'Hepatic Fibrosis and Cardiovascular Risk are evaluated by non invasive tests'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male or female evaluated in a dedicated hepatology day hospital, as part of a first diagnostic workup or follow-up for already known NAFLD', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NAFLD patients regardless of disease stage of severity (from simple steatosis to cirrhosis)\n* Patient without known heart disease\n* Patient agreeing to participate and who has given his non opposition\n\nExclusion Criteria:\n\n* Association with another cause of liver disease\n* Already known coronary artery disease\n* Pregnancy or breastfeeding in progress'}, 'identificationModule': {'nctId': 'NCT04774302', 'acronym': 'Cardio-NASH', 'briefTitle': 'Correlation Between Hepatic Fibrosis and Cardiovascular Risk Evaluated by Non-invasive Tests in Patients With NAFLD', 'organization': {'class': 'OTHER', 'fullName': 'Clinique Pasteur'}, 'officialTitle': 'Study of Correlation Between Hepatic Fibrosis and Cardiovascular Risk Evaluated by Non-invasive Tests in Patients With Nonalcoholic Fatty Liver Disease', 'orgStudyIdInfo': {'id': '2020-A03423-36'}}, 'contactsLocationsModule': {'locations': [{'zip': '31 076', 'city': 'Toulouse', 'country': 'France', 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Maeva GUILLAUME, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique Pasteur'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique Pasteur', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, MD', 'investigatorFullName': 'Dr Maeva GUILLAUME', 'investigatorAffiliation': 'Clinique Pasteur'}}}}