Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-03-03 @ 3:06 PM
Study NCT ID:
NCT01763034
Status:
UNKNOWN
Last Update Posted:
2013-04-23
First Post:
2012-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Limb Ischemic Preconditioning for Prevention of Contrast Media Induced Nephropathy in Diabetic Kidney Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-04-22', 'studyFirstSubmitDate': '2012-12-23', 'studyFirstSubmitQcDate': '2013-01-06', 'lastUpdatePostDateStruct': {'date': '2013-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'kidney injury before and after coronary angiogram.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Serum Cystatin C Before and After Coronary Angiogram', 'Serum Creatinine Before and After Coronary Angiogram']}, 'descriptionModule': {'briefSummary': 'Contrast media induced nephropathy (CIN) is considered to be a serious complication in patient who underwent coronary angiogram (CAG). The pathogenesis of CIN does not well understood. The probable one is the contrast media makes the afferent vessel in glomeruli constrict and results in renal shut down. Limb ischemic preconditioning, a procedure that makes muscles become ischemic and adapt themselves to produce some cytokines for signaling the vessel more dilated. After the reperfusion, these cytokines are getting back to systemic circulation and effect the afferent vessel in glomeruli to become more dilated and prevent CIN.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented diabetic kidney disease\n* Elective coronary angiogram\n* Glomerular filtration rate \\< 60 ml/min by Cockroft-Gault or Modification of Diet in Renal Disease or CKD-EPI\n\nExclusion Criteria:\n\n* Refuse or reject to inform consented\n* Hemodynamic compromise (Heart failure, need for intraaortic balloon pump)\n* Expose to drug or chemical substances potentially to be a nephrotoxic agent with in 1 mo (Not include preexisting Angiotensin converting enzyme inhibitor or Angiotensin receptor blocker with stable serum creatinine)\n* Documented or suspected of peripheral arterial disease, upper or lower limb\n* Bleeding diathesis\n* Contraindicated for coronary angiogram\n* currently on renal replacement therapy'}, 'identificationModule': {'nctId': 'NCT01763034', 'briefTitle': 'Limb Ischemic Preconditioning for Prevention of Contrast Media Induced Nephropathy in Diabetic Kidney Patient', 'organization': {'class': 'OTHER', 'fullName': 'Ramathibodi Hospital'}, 'officialTitle': 'Limb Ischemic Preconditioning for Prevention of Contrast Media Induced Nephropathy in Diabetic Kidney Patient', 'orgStudyIdInfo': {'id': 'RAMA-CIN01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'limb ischemia', 'interventionNames': ['Procedure: limb ischemic preconditioning']}], 'interventions': [{'name': 'limb ischemic preconditioning', 'type': 'PROCEDURE', 'description': 'use a simple blood pressure cuff inflate for 5 minutes and deflate for 5 minutes alternately in each arms total = 3 cycle in each arm', 'armGroupLabels': ['limb ischemia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'SIRAPAT POONVUTIKUL, MD', 'role': 'CONTACT', 'email': 'boybm027@hotmail.com', 'phone': '66891038796'}], 'facility': 'Ramathibodi Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'SIRAPAT POONVUTIKUL, MD', 'role': 'CONTACT', 'email': 'boybm027@hotmail.com', 'phone': '66891038796'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ramathibodi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiology unit', 'investigatorFullName': 'Sirapat Poonvutikul', 'investigatorAffiliation': 'Ramathibodi Hospital'}}}}