Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2026-01-03 @ 8:21 PM
Study NCT ID:
NCT03761368
Status:
COMPLETED
Last Update Posted:
2020-11-19
First Post:
2018-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury in Patients Undergoing Elective PCI
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stokfisz.karolina@gmail.com', 'phone': '+48422014260', 'title': 'Karolina Stokfisz', 'organization': 'Medical University of Łódź'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '1. Single-center trial.\n2. Relatively small sample size.\n3. We were unable to observe sufficient number of events, such as CI-AKI, mortality, need for dialysis as an endpoint.'}}, 'adverseEventsModule': {'timeFrame': 'up to one month', 'eventGroups': [{'id': 'EG000', 'title': 'RIPC Group', 'description': 'The RIPC group underwent Remote Ischemic Preconditioning.\n\nRemote Ischemic Preconditioning: four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper-arm cuff', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 1, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Patients from control group had sham Remote Ischemic Preconditioning.\n\nSham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'skin petechiae', 'notes': 'petechiae on the skin of preconditioned arm distally to upper - arm cuff placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Contrast Induced-Acute Kidney Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RIPC Group', 'description': 'The RIPC group underwent Remote Ischemic Preconditioning.\n\nRemote Ischemic Preconditioning: four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Patients from control group had sham Remote Ischemic Preconditioning.\n\nSham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 to 72 hours after contrast exposure', 'description': 'absolute rise of ≥ 0.5 mg/dL (44 µmol/L) and/or a relative increase of 25% in serum creatinine compared to baseline', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Need of Renal Replacement Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RIPC Group', 'description': 'The RIPC group underwent Remote Ischemic Preconditioning.\n\nRemote Ischemic Preconditioning: four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Patients from control group had sham Remote Ischemic Preconditioning.\n\nSham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 7 days after contrast exposure', 'description': 'qualification for RRT according to standard clinical criteria (level of serum creatinine, serum urea concentration, electrolytes levels (sodium, potassium, chlorides), hydration management)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Presented Cardiogenic Shock', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RIPC Group', 'description': 'The RIPC group underwent Remote Ischemic Preconditioning.\n\nRemote Ischemic Preconditioning: four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Patients from control group had sham Remote Ischemic Preconditioning.\n\nSham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 7 days after contrast exposure', 'description': 'sustained hypotension (systolic blood pressure \\< 90 mm Hg for ≥30 min)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Death of Any Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RIPC Group', 'description': 'The RIPC group underwent Remote Ischemic Preconditioning.\n\nRemote Ischemic Preconditioning: four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Patients from control group had sham Remote Ischemic Preconditioning.\n\nSham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to one month after contrast exposure', 'description': 'Number of patients who died.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RIPC Group', 'description': 'The RIPC group underwent Remote Ischemic Preconditioning.\n\nRemote Ischemic Preconditioning: four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Patients from control group had sham Remote Ischemic Preconditioning.\n\nSham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients aged over 18 years presented with stable angina pectoris, admitted to Intensive Cardiac Therapy Clinic Medical University of Lodz and scheduled for elective CA with follow-up PCI.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'RIPC Group', 'description': 'The RIPC group underwent Remote Ischemic Preconditioning.\n\nRemote Ischemic Preconditioning: four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left arm cuff'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Patients from control group had sham Remote Ischemic Preconditioning.\n\nSham Remote Ischemic Preconditioning: deflated cuff placed on the left arm for 40 min'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Contrast Medium Intake', 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000', 'lowerLimit': '80', 'upperLimit': '140'}, {'value': '110', 'groupId': 'BG001', 'lowerLimit': '90', 'upperLimit': '140'}, {'value': '110', 'groupId': 'BG002', 'lowerLimit': '80', 'upperLimit': '140'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ml', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Serum creatinine on admission', 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000', 'lowerLimit': '81', 'upperLimit': '96'}, {'value': '88', 'groupId': 'BG001', 'lowerLimit': '82', 'upperLimit': '101'}, {'value': '88', 'groupId': 'BG002', 'lowerLimit': '81', 'upperLimit': '99'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'NGAL on admission', 'classes': [{'categories': [{'measurements': [{'value': '71.3', 'groupId': 'BG000', 'lowerLimit': '55.8', 'upperLimit': '86.8'}, {'value': '80.6', 'groupId': 'BG001', 'lowerLimit': '55.8', 'upperLimit': '101.2'}, {'value': '74.4', 'groupId': 'BG002', 'lowerLimit': '55.8', 'upperLimit': '102.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-01', 'size': 163617, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-10-08T12:52', 'hasProtocol': False}, {'date': '2018-01-01', 'size': 215607, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-11-02T10:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Blinded investigator, not involved in either CA or randomization procedure, performed assignment intervention.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'After admission to the Department, patients were randomly assigned in 1:1 ratio to either control group or RIPC - group by means of a computerized randomization table.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-02', 'studyFirstSubmitDate': '2018-11-29', 'resultsFirstSubmitDate': '2020-06-12', 'studyFirstSubmitQcDate': '2018-11-30', 'lastUpdatePostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-08', 'studyFirstPostDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Contrast Induced-Acute Kidney Injury', 'timeFrame': '48 to 72 hours after contrast exposure', 'description': 'absolute rise of ≥ 0.5 mg/dL (44 µmol/L) and/or a relative increase of 25% in serum creatinine compared to baseline'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Need of Renal Replacement Therapy', 'timeFrame': 'up to 7 days after contrast exposure', 'description': 'qualification for RRT according to standard clinical criteria (level of serum creatinine, serum urea concentration, electrolytes levels (sodium, potassium, chlorides), hydration management)'}, {'measure': 'Number of Participants Who Presented Cardiogenic Shock', 'timeFrame': 'up to 7 days after contrast exposure', 'description': 'sustained hypotension (systolic blood pressure \\< 90 mm Hg for ≥30 min)'}, {'measure': 'Death of Any Cause', 'timeFrame': 'up to one month after contrast exposure', 'description': 'Number of patients who died.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['remote ischemic preconditioning', 'contrast induced-acute kidney injury', 'neutrophil gelatinase-associated lipocalin', 'percutaneous coronary intervention'], 'conditions': ['Remote Ischemic Preconditioning', 'Contrast Induced - Acute Kidney Injury']}, 'referencesModule': {'references': [{'pmid': '32874376', 'type': 'DERIVED', 'citation': 'Stokfisz K, Ledakowicz-Polak A, Kidawa M, Zielinska M. Remote Ischemic Preconditioning and Contrast-Induced Acute Kidney Injury in Patients Undergoing Elective Percutaneous Coronary Intervention: A Randomized Clinical Trial. Curr Ther Res Clin Exp. 2020 Aug 5;93:100599. doi: 10.1016/j.curtheres.2020.100599. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'Prospective, randomized, sham-controlled clinical study was conducted to assess whether RIPC reduces the incidence of CI-AKI measured standard way of using SCr concentration but also with the use of serum NGAL as a new potential biomarker of kidney injury. Furthermore, the aim of investigation was to analyse the safety and clinical outcomes of RIPC after elective coronary angiography (CA) followed by percutaneous coronary intervention (PCI).', 'detailedDescription': 'Nowadays CI-AKI is defined according to serum creatinine concentration (SCr) as any of the following: (1) an absolute rise of ≥ 0.5 mg/dL (44 µmol/L) and/or (2) a relative increase of 25% in serum creatinine compared to baseline within 48 to 72 hours after contrast administration. In the last decades, several novel biomarkers of AKI have been studied including neutrophil gelatinase-associated lipocalin (NGAL). Furthermore, remote ischemic preconditioning (RIPC) turned out to be one of the most promising and intriguing non-pharmacological strategy. This simple procedure consisting of brief, non-lethal episodes of ischemia and reperfusion applied in one tissue or organ protects remote tissues or organs from subsequent injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged over 18 years\n* patients with stable angina pectoris\n* patients admitted to Intensive Cardiac Therapy Clinic Medical University of Lodz with intention of elective CA with follow-up PCI.\n\nExclusion Criteria:\n\n* history of severe injuries up to 2 months before intervention\n* history of surgeries up to 2 months before intervention\n* history of cancer,\n* acute inflammation during hospitalization\n* chronic autoimmunologic diseases\n* patients needing hemodialysis\n* chronic kidney disease in stage 4 or 5 (eGFR\\<30 ml/min/1,73m2)\n* peripheral vascular disease affecting upper limbs.'}, 'identificationModule': {'nctId': 'NCT03761368', 'briefTitle': 'Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury in Patients Undergoing Elective PCI', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Lodz'}, 'officialTitle': 'Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury in Patients Undergoing Elective Percutaneous Coronary Intervention - Randomised Clinical Trial', 'orgStudyIdInfo': {'id': 'RNN/219/13/KE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RIPC group', 'description': 'The RIPC group underwent Remote Ischemic Preconditioning.', 'interventionNames': ['Procedure: Remote Ischemic Preconditioning']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'Patients from control group had sham Remote Ischemic Preconditioning.', 'interventionNames': ['Procedure: Sham Remote Ischemic Preconditioning']}], 'interventions': [{'name': 'Remote Ischemic Preconditioning', 'type': 'PROCEDURE', 'otherNames': ['RIPC'], 'description': 'four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff', 'armGroupLabels': ['RIPC group']}, {'name': 'Sham Remote Ischemic Preconditioning', 'type': 'PROCEDURE', 'otherNames': ['Sham RIPC'], 'description': 'deflated cuff placed on the left arm for 40 min', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92-213', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Intensive Cardiac Therapy Clinic', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}], 'overallOfficials': [{'name': 'Marzenna Zielinska, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of Lodz'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': '3 years after the end of the study', 'ipdSharing': 'YES', 'description': 'The data sets used and/or analyzed during the current study are available from the corresponding author on reasonable request.', 'accessCriteria': 'on reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Lodz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Karolina Stokfisz', 'investigatorAffiliation': 'Medical University of Lodz'}}}}