Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2026-01-13 @ 6:46 AM
Study NCT ID:
NCT02643706
Status:
UNKNOWN
Last Update Posted:
2015-12-31
First Post:
2015-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between ALDH2 and CIN
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '5 ml vein blood samples were collected from peripheral vein before coronary angiography or percutaneous coronary intervention.The blood is used to detecte the renal function , the genotype of aldehyde dehydrogenase 2 and aldehyde dehydrogenase activity. Another 5 ml vein blood samples were collected from peripheral vein to detecte the renal function 24-72 hours after the surgery. The samples would be centrifuged and saved in a -80℃ ultra-low temperature refrigerator.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-28', 'studyFirstSubmitDate': '2015-12-19', 'studyFirstSubmitQcDate': '2015-12-28', 'lastUpdatePostDateStruct': {'date': '2015-12-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with different ALDH2 genotype', 'timeFrame': '1-30 days after samples collected'}, {'measure': 'Change from baseline renal function after the operation', 'timeFrame': 'at admission and 24-72hours after coronary angiography or coronary intervention', 'description': 'The baseline of renal function will be tested at the next morning after admission .The renal function will be tested again 24-72 hours after coronary angiography or coronary intervention.The changes of renal function will be recorded.The renal function index contains serum creatinine,urea nitrogen and cystatin C.'}], 'secondaryOutcomes': [{'measure': 'Aldehyde dehydrogenase 2 activity', 'timeFrame': '1-30 days after samples collected'}, {'measure': 'Activated oxygen protein products, 4-HNE and hs-CRP', 'timeFrame': '1-30 days after samples collected', 'description': 'Activated oxygen protein products , 4-HNE and hs-CRP as markers for oxidative stress and inflammation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Aldehyde dehydrogenase 2', 'contrast induced nephropathy', 'Gene polymorphism'], 'conditions': ['Radiographic Contrast Agent Nephropathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to investigate the relationship between the gene polymorphism of aldehyde dehydrogenase 2 and contrast induced nephropathy and its mechanism.', 'detailedDescription': 'Patients undergoing coronary angiography or percutaneous coronary intervention will be recruited in this study after they sign the informed consent.5ml venous blood was extracted from the peripheral vein before the operation to detect the renal function, the genotype and enzyme activity of aldehyde dehydrogenase 2 ,and the levels of oxidative stress and inflammation.Another 5ml venous blood was extracted from the peripheral vein 24-72 hours after the operation to detect the renal function and the levels of oxidative stress and inflammation.Activated oxygen protein products , 4-HNE and hs-CRP as markers for oxidative stress and inflammation.The renal function index contains serum creatinine，urea nitrogen and cystatin C.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing elective coronary intervention or coronary angiography in Qilu hospital from December 2015 to December 2016', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing elective coronary intervention or coronary angiography at Yu Qilu hospital.\n* All the patients or their guardians must sign the consent form before entering the trial.\n\nExclusion Criteria:\n\n* Patients with acute renal failure, renal transplantation, end-stage renal disease, or dialysis treatment, GFR \\< 15ml/min.\n* Use of renal toxicity drugs during the treatment, such as non steroidal anti-inflammatory drugs, etc.\n* Patients who has used contrast agent 10 days before the operation.\n* Cardiac shock, hypotension (systolic blood pressure \\< 95mmHg),or hyper- tension with difficulty to control.\n* Allergy to contrast media.\n* Congestive heart failure (left ventricular ejection fraction\\<40%), cardiac function NYHA grade IV.\n* Pregnancy or lactation.'}, 'identificationModule': {'nctId': 'NCT02643706', 'acronym': 'REACTION', 'briefTitle': 'Relationship Between ALDH2 and CIN', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'Relationship Between the Gene Polymorphism of Aldehyde Dehydrogenase 2 and Contrast Induced Nephropathy', 'orgStudyIdInfo': {'id': 'Qiluexcellentyouth'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CIN', 'description': 'CIN was defined as an absolute increase in serum creatinine concentration of at least 0.5 mg/dL (44.2umol/l) or a relative rise of at least 25% from baseline on the follow-up blood sample drawn 24 to 72 hours after the operation.'}, {'label': 'Control', 'description': 'The enrolled patients without CIN.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Feng Xu, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'xufengsdu@126.com', 'phone': '86-18560083066'}], 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Feng Xu', 'role': 'CONTACT', 'email': 'Xufengsdu@126.com', 'phone': '18560083066'}], 'overallOfficials': [{'name': 'Feng Xu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Qilu Hospital of Shandong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}