Ignite Creation Date:
2025-12-26 @ 5:17 PM
Ignite Modification Date:
2025-12-31 @ 11:27 AM
Study NCT ID:
NCT01109706
Status:
COMPLETED
Last Update Posted:
2021-09-20
First Post:
2010-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relevance of Plasma PCSK9 Concentration as a Biomarker in Acute Coronary Syndrome.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2015-07-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-13', 'studyFirstSubmitDate': '2010-04-20', 'studyFirstSubmitQcDate': '2010-04-22', 'lastUpdatePostDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Syntax score (for evaluate coronary damages) and plasmatic concentration of PCSK9', 'timeFrame': 'Day 1, Day 2, Day 3, Day 4', 'description': 'Assessing the correlation between plasma concentration of PCSK9 and coronary damage severity in patients with acute coronary syndrome. Coronary lesions will be measured using the SYNTAX score (J0: admission day), and PCSK9 concentration will be evaluated using blood analysis (J0 (admission), J1, J2, J3 \\& J4).'}], 'secondaryOutcomes': [{'measure': 'Correlation between PCSK9 and morbidity/mortality', 'timeFrame': 'Day 1, Day 2, Day 3, Day 4', 'description': 'Assessing the correlation between plasma PCSK9 (J1, J2, J3, J4) concentration and one-year morbidity/mortality of patients with acute coronary syndrome'}, {'measure': 'association between PCSK9 and metabolic/inflammatory factors', 'timeFrame': 'Day 1, Day 2, Day 3, Day 4', 'description': 'Identification of metabolic and inflammatory factors (glycemia, insulinemia, HbA1C, CRPus…) associated to plasma PCSK9 concentration'}, {'measure': 'kinetic of PCSK9 for statin-treated patients', 'timeFrame': 'Day 1, Day 2, Day 3, Day 4', 'description': 'Measurement of PCSK9 kinetic variation during ACS acute phase in patients treated with artovastatin 80 mg/day (J1, J2, J3, and J4)'}, {'measure': 'kinetic of PCSK9 after intensive care', 'timeFrame': 'Day 1, Day 2, Day 3, Day 4', 'description': 'Determination of PCSK9 kinetic variation at 1 and 6 months after intensive care, during their normal follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute coronary syndrome', 'PCSK9', 'cardiovascular safety'], 'conditions': ['Acute Coronary Syndrome']}, 'descriptionModule': {'briefSummary': 'PCSK9 (Proprotein convertase subtilisin kexin type 9) plays a key role in LDL-cholesterol (LDLC) metabolism by inhibiting LDL receptor (LDLR) at post-transcriptional level. PCSK9 loss of function mutations are associated to decreased LDLC levels and a cardiovascular protection. In this context, the development of pharmacological inhibitors of PCSK9, in association with statins treatment, represents a major therapeutic issue for LDLC modulation. It was previously shown that PCSK9 plasmatic concentration correlated with plasmatic LDLC, TG and glucose concentrations. However, no data are available on predictive value of PCSK9 plasmatic level concerning coronary disease severity.\n\nThe main objective of this study is to determine whether plasmatic PCSK9 concentration is linked to coronary damage severity in patients with acute coronary syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of both sexes, 18 years old minimum, with an acute coronary syndrome, treated or not with statins, admitted to cardiological intensive care unit.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* more than 18 years old\n* Acute coronary syndrome (ST+ or ST-)\n* 2 groups of patients: with statin, and without statin treatment\n\nExclusion criteria:\n\n* Patient who had cancer during the last 5 years or with cancer in progress\n* Patient with severe infection in progress\n* Hepatic failure (TP\\<50%)\n* Severe kidney failure\n* Patient unable to give his consent to the study'}, 'identificationModule': {'nctId': 'NCT01109706', 'acronym': 'PC-SCA-9', 'briefTitle': 'Relevance of Plasma PCSK9 Concentration as a Biomarker in Acute Coronary Syndrome.', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Relevance of Plasma PCSK9 Concentration as a Biomarker in Acute Coronary Syndrome.', 'orgStudyIdInfo': {'id': 'BRD/10/03-ZE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patient treated by statines', 'interventionNames': ['Other: biological parameters dosage']}, {'label': 'patient without normolipidemic treatment', 'interventionNames': ['Other: biological parameters dosage']}], 'interventions': [{'name': 'biological parameters dosage', 'type': 'OTHER', 'description': '200 patients will be enrolled in the study (n=100 patients under statin treatment, n=100 patients without statin).\n\nAfter checking inclusion and non-inclusion criteria and obtaining informed consent from the patients. The SYNTAX score will be calculated and will allow to determine coronary analysis will be done at J1 and J4 (glucose, HbA1C, lipids, ApoA1, ApoB, sterols, plasmatic bile acids, insulinemia, creatinin clearance, hepatic function panel, CRPus and PCSK9 level assessment).\n\nThen, a sub-group of 30 patients will have supplementary blood analysis at 1 and 6 months after their admission, during their usual follow-up.', 'armGroupLabels': ['patient treated by statines', 'patient without normolipidemic treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Nantes', 'country': 'France', 'facility': 'Nantes University hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'Bertrand Cariou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}