Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-02-22 @ 9:39 AM
Study NCT ID:
NCT02792868
Status:
COMPLETED
Last Update Posted:
2017-04-07
First Post:
2016-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biological Phosphocalcic Metabolism and Coronary Artery Calcifications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood 24h urines'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-06', 'studyFirstSubmitDate': '2016-05-26', 'studyFirstSubmitQcDate': '2016-06-02', 'lastUpdatePostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plasma levels of FGF23 according to the calcium score, determined by an ELISA method', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': 'Study a sample of patients in primary prevention, moderate cardiovascular risk (n = 83 patients), with normal, non-diabetic renal function. The investigators quantify the phophocalcic intake and excretion, realizing a food examination and a urine collection of 24 particular. The investigators will measure plasma levels of FGF23 serum calcium, phosphatemia, the investigators will calculate the tubular reabsorption of phosphate. The investigators will conduct a quantitative assessment of coronary calcification by a non-injected CT scan, measuring semi automated way Agatston calcium score. There will be an analysis of collinearity. An adjustment will be made for confounding variables in a generalized linear regression model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patient with cardiovascular risk', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalization for a cardiovascular check in the Detection Centre and the Atherosclerosis Prevention (CHU Rangueil Toulouse)\n* In primary prevention of coronary heart disease\n* Introducing an intermediate cardiovascular risk according to the European SCORE equation, that is to say, a risk of cardiovascular death at 10 years greater than or equal to 1% and less than 5%\n* signed the informed consent,\n\nExclusion Criteria:\n\n* Chronic renal failure patients with an estimated GFR less than 60 mL / min / 1.73m2, due to alterations in phosphate metabolism,\n* Patients receiving glucose-lowering therapy,\n* Patients with a fasting blood glucose greater capillary or equal to 1.10 g / l, confirmed by a plasma glucose greater than or equal to 1.10g / l.\n* The diuretic therapy patients (due to a change in urinary electrolytes)\n* HIV-positive patients for HIV, antiretroviral (due to a change in urinary electrolytes)\n* Pregnant women,\n* Patients under judicial protection, guardianship or trusteeship.'}, 'identificationModule': {'nctId': 'NCT02792868', 'acronym': 'BIOCAC', 'briefTitle': 'Biological Phosphocalcic Metabolism and Coronary Artery Calcifications', 'organization': {'class': 'OTHER', 'fullName': 'French Cardiology Society'}, 'officialTitle': 'Biological Phosphocalcic Metabolism and Coronary Artery Calcifications', 'orgStudyIdInfo': {'id': '2015.02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patient', 'description': 'patient with cardiovascular risk (moderate)', 'interventionNames': ['Other: 24 h urines analyses']}], 'interventions': [{'name': '24 h urines analyses', 'type': 'OTHER', 'description': 'patient collects urines during 24h', 'armGroupLabels': ['patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'Chu Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Jean FERRIERES', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU RANGUEIL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French Cardiology Society', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}