Ignite Creation Date:
2025-12-24 @ 1:31 PM
Ignite Modification Date:
2026-01-01 @ 2:34 PM
Study NCT ID:
NCT01400295
Status:
COMPLETED
Last Update Posted:
2014-09-16
First Post:
2011-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PREdictive Value of COntrast voluMe to creatinINe Clearance Ratio
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-14', 'studyFirstSubmitDate': '2011-07-21', 'studyFirstSubmitQcDate': '2011-07-21', 'lastUpdatePostDateStruct': {'date': '2014-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, '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': 'An early abnormal increase in serum creatinine', 'timeFrame': '24h', 'description': 'An early abnormal increase in serum creatinine defined as an increase in serum creatinine of more than 0.5 mg/dl from the baseline within 24h of contrast exposure'}, {'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'}, {'measure': 'Major adverse clinical events', 'timeFrame': '1month', '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'}, {'measure': 'An early abnormal increase in serum cystatin C', 'timeFrame': '24h', 'description': 'An early abnormal increase in serum cystatin C was defined as an increase more than 10% from the baseline within 24h of contrast exposure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['contrast-induced nephropathy', 'contrast medium', 'creatinine clearance', 'coronary angiography', 'diabetes', 'chronic kidney disease'], 'conditions': ['Contrast Induced Nephropathy']}, 'referencesModule': {'references': [{'pmid': '32867690', 'type': 'DERIVED', 'citation': 'Liu L, Liu J, Lei L, Wang B, Sun G, Guo Z, He Y, Song F, Lun Z, Liu B, Chen G, Chen S, Yang Y, Liu Y, Chen J. A prediction model of contrast-associated acute kidney injury in patients with hypoalbuminemia undergoing coronary angiography. BMC Cardiovasc Disord. 2020 Aug 31;20(1):399. doi: 10.1186/s12872-020-01689-6.'}, {'pmid': '32285318', 'type': 'DERIVED', 'citation': 'Liu Y, Chen S, Ye J, Xian Y, Wang X, Xuan J, Tan N, Li Q, Chen J, Ni Z. Random forest for prediction of contrast-induced nephropathy following coronary angiography. Int J Cardiovasc Imaging. 2020 Jun;36(6):983-991. doi: 10.1007/s10554-019-01730-6. Epub 2020 Apr 13.'}, {'pmid': '31179103', 'type': 'DERIVED', 'citation': 'Liu J, Sun G, He Y, Song F, Chen S, Guo Z, Liu B, Lei L, He L, Chen J, Tan N, Liu Y. Early beta-blockers administration might be associated with a reduced risk of contrast-induced acute kidney injury in patients with acute myocardial infarction. J Thorac Dis. 2019 Apr;11(4):1589-1596. doi: 10.21037/jtd.2019.04.65.'}, {'pmid': '28866117', 'type': 'DERIVED', 'citation': 'Guo XS, Chen SQ, Duan CY, Li HL, Bei WJ, Liu Y, Tan N, Chen PY, Chen JY. Association of post-procedural early (within 24h) increases in serum creatinine with all-cause mortality after coronary angiography. Clin Chim Acta. 2017 Nov;474:96-101. doi: 10.1016/j.cca.2017.08.036. Epub 2017 Sep 1.'}]}, 'descriptionModule': {'briefSummary': 'To determine a relatively safe contrast media volume to creatinine clearance cut-off value to avoid contrast-induced nephropathy in patients following coronary angiography', 'detailedDescription': 'Contrast media volume to creatinine clearance (V/CrCl) ratios were obtained from consecutive consenting patients after coronary angiography. 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 contrast-induced nephropathy was assessed using multivariate logistic regression.Subgroup analysis was performed on patients with creatinine clearance \\< 60 ml/min,diabetes,emergent angiography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The investigators reviewed all consecutive patients who were undergoing coronary angiography', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who agreed to stay in the hospital for 2-3 days after coronary angiography\n* provided written informed consent\n\nExclusion Criteria:\n\n* pregnancy\n* lactation\n* intravascular administration of an contrast medium within the previous seven days\n* treatment with metformin,aminoglycosides,N-acetylcysteine (NAC),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， severe concomitant disease renal transplantation , or end-stage renal disease necessitating dialysis\n* patients who died during coronary angiography'}, 'identificationModule': {'nctId': 'NCT01400295', 'acronym': 'PRECOMIN', 'briefTitle': 'PREdictive Value of COntrast voluMe to creatinINe Clearance Ratio', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'Predictive Value of the Contrast Media Volume to Creatinine Clearance Ratio for the Risk of Contrast-Induced Nephropathy After Coronary Angiography', 'orgStudyIdInfo': {'id': '20100917'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'coronary angiography', 'description': 'The investigators reviewed all consecutive patients who were undergoing coronary angiography'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangdong Cardiovascular Institute,Guangdong General Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Jiyan Chen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Guangdong Cardiovascular Institute,Guangdong General Hospital'}, {'name': 'Yong Liu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Guangdong Cardiovascular Institute,Guangdong General Hospital'}, {'name': 'Yingling Zhou, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Guangdong Cardiovascular Institute,Guangdong General Hospital'}, {'name': 'Ning Tan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Guangdong Cardiovascular Institute,Guangdong General Hospital'}, {'name': 'Jianfang Luo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guangdong Cardiovascular Institute,Guangdong General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jiyan Chen', 'investigatorAffiliation': "Guangdong Provincial People's Hospital"}}}}