Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-02 @ 11:04 AM
Study NCT ID:
NCT03075566
Status:
UNKNOWN
Last Update Posted:
2017-03-09
First Post:
2017-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coronary Artery Disease: a Case- Control Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum, Plasma, DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 517}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-03', 'studyFirstSubmitDate': '2017-02-05', 'studyFirstSubmitQcDate': '2017-03-03', 'lastUpdatePostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemical parameters', 'timeFrame': '1 Days', 'description': '* Glucose (mmol/l), urae (mmol/l), creatinin (µmol/l), total cholesterol (mmol/l), high density lipoprotein cholesterol, HDL-C (mmol/l), triglycerides (mmol/l), lipoprotein(a) (g/l), apolipoproteins, apo (g/l) were measured only once in each patient at admission, before angiography and in each control group participant using the COBAS INTEGRA 400 chemical analyzer (Roche Diagnostic, Germany).\n* Troponin I (ng/ml), creatine kinase (CK) (UI/L), creatine kinase MB Isoenzyme (CK-MB)(UI/L), glutamic-oxaloacetic transaminase (ASAT) (UI/L) were measured using the COBAS INTEGRA 400 chemical analyzer (Roche Diagnostic, Germany). Only one measure was performed for each participant regarding all these parameters.\n* Light density lipoprotein cholesterol, LDL-C (mmol/l) was estimated using the Friedewald equation. Only one measure was performed for each participant.\n* Values which were out of the confidence range were considered as abnormal values.'}, {'measure': 'Inflammatory markers', 'timeFrame': '2 Days', 'description': '* Serum Amyloid A (SAA) (mg/l) was measured using the BN Prospec, Siemens.\n* High sensitivity C reactive protein, hsCRP (mg/l) was measured using the COBAS INTEGRA 400 chemical analyzer (Roche Diagnostic, Germany).\n* Activin A (pg/ml) was quantified at 450nm using a commercially available ELISA kit (AbFrontier, Young In Frontier Co., Ltd, Korea). Only one measure was performed for each participant.\n* Interleukin-6 (pg/ml) was measured using a Cobas E601 analyzer (Roche Diagnostics, Germany). Only one measure was performed for each participant.\n* Values which were out of the confidence range were considered as abnormal values.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coronary artery disease', 'risk factors', 'inflammation', 'biomarkers', 'atherosclerosis'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '38017432', 'type': 'DERIVED', 'citation': 'Bouzidi N, Gamra H. Relationship between serum interleukin-6 levels and severity of coronary artery disease undergoing percutaneous coronary intervention. BMC Cardiovasc Disord. 2023 Nov 28;23(1):586. doi: 10.1186/s12872-023-03570-8.'}]}, 'descriptionModule': {'briefSummary': 'Atherosclerosis is a chronic inflammatory condition, which is associated by the involvement of several pathological events, and alteration in the serum levels of pro- and anti-inflammatory, and lipid markers.\n\nThe investigators evaluated the contribution of serum biomarkers levels to the pathogenesis of coronary artery disease, namely their association with risk factors, clinical presentation, extent and severity of atherosclerotic changes accompanying coronary artery disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '* 310 patients with Coronary Artery Disease\n* 207 healthy subjects', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Coronary Artery Disease\n\nExclusion Criteria:\n\n* Severe respiratory disease\n* Liver disease\n* kidney disease\n* Inflammatory diseases (infections, autoimmune disorders, malignancy).'}, 'identificationModule': {'nctId': 'NCT03075566', 'briefTitle': 'Coronary Artery Disease: a Case- Control Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Monastir'}, 'officialTitle': 'Clinical and Biochemical Markers in Coronary Artery Disease', 'orgStudyIdInfo': {'id': '1500170'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Healthy subjects', 'type': 'BIOLOGICAL', 'description': '\\- 207 healthy subjects were donors,(33.2±12.2 years) recruited from the Blood Bank Department of the University Hospital (Mahdia, Tunisia).'}, {'name': 'Patients', 'type': 'BIOLOGICAL', 'description': '\\- 310 subjects with CAD (60.3±11.0 years) were admitted to the Department of Cardiology, University Hospital (Monastir, Tunisia).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Monastir', 'state': 'Ibn Sina Street', 'status': 'RECRUITING', 'country': 'Tunisia', 'contacts': [{'name': 'NADIA BOUZIDI, PhD', 'role': 'CONTACT', 'email': 'nadiabouzidi1@gmail.com', 'phone': '21622987518'}], 'facility': 'Faculty of Pharmacy', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}], 'centralContacts': [{'name': 'NADIA BOUZIDI, PhD', 'role': 'CONTACT', 'email': 'nadiabouzidi1@gmail.com', 'phone': '21622987518'}], 'overallOfficials': [{'name': 'Salima Ferchichi, Pr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Monastir, Faculty of Pharmacy of Monastir, Tunisia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nadia Bouzidi, PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Bouzidi Nadia, PhD', 'investigatorFullName': 'Nadia Bouzidi, PhD', 'investigatorAffiliation': 'University of Monastir'}}}}