Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-02-20 @ 10:32 PM
Study NCT ID:
NCT02089360
Status:
UNKNOWN
Last Update Posted:
2014-03-17
First Post:
2014-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adavanced Glycated Endproducts and Development of CAD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood sample is taken for all patients underwent coronary angiogram after getting informed consent, and stored in requested condition, for measuring serum levels of different kinds of factors.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'lastUpdateSubmitDate': '2014-03-14', 'studyFirstSubmitDate': '2014-03-13', 'studyFirstSubmitQcDate': '2014-03-14', 'lastUpdatePostDateStruct': {'date': '2014-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Serum level of AGEs', 'timeFrame': 'baseline', 'description': 'serum levels of AGEs will be measured and the relationship between clinical outcomes will be analyzed.'}], 'primaryOutcomes': [{'measure': 'MACE', 'timeFrame': '5-year', 'description': 'including death, occurrence of myocardial infarction, and coronary revascularization'}], 'secondaryOutcomes': [{'measure': 'progression in coronary atherosclerosis', 'timeFrame': '5-year', 'description': 'repeated coronary angiogram in patients with symptom aggravation or occurrence of myocardial infarction, to evaluate the progression of coronary lesions, comparing to the baseline results.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Advanced glycation end product', 'coronary', 'atherosclerosis', 'inflammation', 'outcome'], 'conditions': ['Atherosclerosis', 'Inflammation']}, 'referencesModule': {'references': [{'pmid': '32887588', 'type': 'DERIVED', 'citation': 'Yang CD, Shen Y, Lu L, Yang ZK, Hu J, Zhang RY, Shen WF, Ding FH, Wang XQ. Visit-to-visit HbA1c variability is associated with in-stent restenosis in patients with type 2 diabetes after percutaneous coronary intervention. Cardiovasc Diabetol. 2020 Sep 4;19(1):133. doi: 10.1186/s12933-020-01111-7.'}, {'pmid': '32878604', 'type': 'DERIVED', 'citation': 'Yang CD, Shen Y, Ding FH, Yang ZK, Hu J, Shen WF, Zhang RY, Lu L, Wang XQ. Visit-to-visit fasting plasma glucose variability is associated with left ventricular adverse remodeling in diabetic patients with STEMI. Cardiovasc Diabetol. 2020 Sep 2;19(1):131. doi: 10.1186/s12933-020-01112-6.'}, {'pmid': '31391045', 'type': 'DERIVED', 'citation': 'Yang CD, Shen Y, Lu L, Ding FH, Yang ZK, Zhang RY, Shen WF, Jin W, Wang XQ. Insulin resistance and dysglycemia are associated with left ventricular remodeling after myocardial infarction in non-diabetic patients. Cardiovasc Diabetol. 2019 Aug 7;18(1):100. doi: 10.1186/s12933-019-0904-3.'}]}, 'descriptionModule': {'briefSummary': "Blood sample is prospectively taken from consecutive patients underwent coronary angiogram in our center, after getting informed consent from the patients. Serum level of advanced glycation end products (AGEs) was measured and the clinical features of patients (including angiographic results) were entered into our database. Clinical follow-up was performed for all patients, and the relationship between AGEs and paitents' outcome were analyzed. Further intervention will be adjusted according to the results,including clinical and basic research in lab.", 'detailedDescription': 'Serum levels of HMGB1, HMGB2, ADAM10, etc. will be measured in lab and animal studies will be designed to intervene the adverse interaction between abnormal serum concentration of AGEs, etc. and worse clinical results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients underwent coronary angiogram', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients underwent coronary angiogram for suspected coronary artery disease and potential percutaneous coronary intervention\n\nExclusion Criteria:\n\n* patients underwent coronary angiogram for other reasons, including pre-surgery examination\n* patients with severe co-morbidity, and life expectancy less than one-year'}, 'identificationModule': {'nctId': 'NCT02089360', 'acronym': 'AGENDA', 'briefTitle': 'Adavanced Glycated Endproducts and Development of CAD', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Study of Serum Level of Advanced Glycated Endproducts and Development of Coronary Atherosclerosis in Patients Undergoing Coronary Angiogram', 'orgStudyIdInfo': {'id': 'RJH20140311'}}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lin Lu, PhD', 'role': 'CONTACT', 'email': 'rjlulin1965@163.com', 'phone': '86-21-64370045', 'phoneExt': '610910'}, {'name': 'Lin Lu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ruijin Hospital, Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Qi Zhang, PhD', 'role': 'CONTACT', 'email': 'rjheart@gmail.com', 'phone': '86-21-64370045', 'phoneExt': '665380'}, {'name': 'Wei Feng Shen, PhD', 'role': 'CONTACT', 'email': 'rjshenweifeng@gmail.com', 'phone': '86-21-64370045', 'phoneExt': '665215'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Cardiac Catheterization Lab', 'investigatorFullName': 'Zhang Qi, MD', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}