Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-04-09 @ 4:53 AM
Study NCT ID:
NCT01399203
Status:
UNKNOWN
Last Update Posted:
2011-08-03
First Post:
2011-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contrast Medium Volume and Contrast-induced Nephropathy After Percutaneous Coronary Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-08-02', 'studyFirstSubmitDate': '2011-07-19', 'studyFirstSubmitQcDate': '2011-07-20', 'lastUpdatePostDateStruct': {'date': '2011-08-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contrast-Induced Nephropathy', 'timeFrame': '48-72 h', 'description': 'Contrast-Induced Nephropathy was defined as an increase in serum creatinine of more than 0.5 mg/dl from the baseline within 48-72 h of contrast exposure'}], 'secondaryOutcomes': [{'measure': 'Major adverse clinical events', 'timeFrame': '1 year', 'description': 'Major adverse clinical events: death, requiring renal replacement therapy, 2nd myocardial infarction,target revascularization,acute heart failure, mechanical ventilation,2nd angina,tachyarrhythmia,hypotension,intra-aortic balloon pump and stroke'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['contrast-induced nephropathy', 'contrast medium', 'creatinine clearance', 'percutaneous coronary intervention'], 'conditions': ['Contrast Induced Nephropathy']}, 'descriptionModule': {'briefSummary': 'To investigate the predictive value of the contrast media volume to creatinine clearance (V/CrCl) ratio for the risk of contrast-induced nephropathy (CIN) (i.e., within 48-72 h) and to determine a relatively safe V/CrCl cut-off value to avoid CIN in patients following PCI', 'detailedDescription': 'contrast media volume to creatinine clearance (V/CrCl) ratios were obtained from consecutive consenting patients after unselective PCI. Receiver-operator characteristic (ROC) curves were used to identify the optimal sensitivity for the observed range of V/CrCl. The predictive value of V/CrCl for the risk of CIN was assessed using multivariate logistic regression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The investigators reviewed all consecutive patients who were undergoing percutaneous coronary intervention', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who agreed to stay in the hospital for 2-3 days after percutaneous coronary intervention\n* provided written informed consent\n* Creatinine Clearance:15-60ml/min\n\nExclusion Criteria:\n\n* pregnancy\n* lactation\n* intravascular administration of an contrast medium within the previous seven days\n* treatment with metformin\n* aminoglycosides\n* N-acetylcysteine (NAC)\n* nonsteroidal anti-inflammatory drugs within the previous 48 h\n* intake of nephrotoxic drugs within the previous seven days\n* history of serious reactions to contrast mediums\n* severe concomitant disease\n* renal transplantation , or end-stage renal disease necessitating dialysis patients who died during percutaneous coronary intervention'}, 'identificationModule': {'nctId': 'NCT01399203', 'acronym': 'CONVIN', 'briefTitle': 'Contrast Medium Volume and Contrast-induced Nephropathy After Percutaneous Coronary Intervention', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'Contrast Medium Volume and Contrast-induced Nephropathy After Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': '2009X41'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'percutaneous coronary intervention', 'description': 'The investigators reviewed all consecutive patients who were undergoing percutaneous coronary intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510100', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ning Tan, MD', 'role': 'CONTACT', 'email': 'tanning100@126.com', 'phone': '8620-83819161'}, {'name': 'Yong Liu, MD', 'role': 'CONTACT', 'email': 'liuyongyisheng@126.com', 'phone': '8615920172292'}, {'name': 'Yong Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jiyan Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yingling Zhou, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jianfang Luo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Shuguang Lin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ning Tan', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Ning Tan, MD', 'role': 'CONTACT', 'email': 'tanning100@126.com', 'phone': '86-20-83819161'}, {'name': 'Yong Liu, MD', 'role': 'CONTACT', 'email': 'liuyongyisheng@126.com', 'phone': '86-15920172292'}], 'overallOfficials': [{'name': 'Yong Liu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Guangdong Provincial People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': "Hainan People's Hospital", 'class': 'OTHER'}, {'name': 'Guangdong Medical College', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Ning Tan, MD', 'oldOrganization': 'Guangdong Cardiovascular Institute,Guangdong General Hospital'}}}}