Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2025-12-26 @ 8:59 PM
Study NCT ID:
NCT04928092
Status:
WITHDRAWN
Last Update Posted:
2022-02-04
First Post:
2021-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Zero Acute Kidney Injury Strategy for Percutaneous Coronary Intervention in Patients With ChronicKidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'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': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The PI is leaving the institution', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-20', 'studyFirstSubmitDate': '2021-05-26', 'studyFirstSubmitQcDate': '2021-06-15', 'lastUpdatePostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cardiac death', 'timeFrame': 'Up to 30 days after PCI procedure', 'description': 'Number of cardiac deaths'}, {'measure': 'Myocardial infarction', 'timeFrame': 'Up to 30 days after PCI procedure', 'description': 'Number of myocardial infarctions'}, {'measure': 'Target lesion revascularization', 'timeFrame': 'Up to 30 days after PCI procedure', 'description': 'Number of target-lesion revascularizations'}, {'measure': 'All-cause mortality', 'timeFrame': 'Up to 30 days after PCI procedure', 'description': 'Number of deaths due to any cause'}, {'measure': 'Pericardial effusion', 'timeFrame': 'Up to 30 days after PCI procedure', 'description': 'Number of pericardial effusion'}, {'measure': 'new need for dialysis', 'timeFrame': 'Up to 30 days after PCI procedure', 'description': 'Number of new patients needing dialysis'}], 'primaryOutcomes': [{'measure': 'Acute Kidney Injury (AKI)', 'timeFrame': 'Up to 72 hours after the procedure', 'description': 'Standard laboratory assays related to renal function will be used to identify which, if any, patients develop AKI'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury', 'Coronary Artery Disease', 'Percutaneous Coronary Intervention']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the outcomes of Percutaneous Coronary Intervention (PCI) in patients with chronic kidney disease (CKD) using smaller doses of contrast dye that are validated as being at low risk of causing injury to the kidneys, with the larger doses that are traditionally used contemporary practice.', 'detailedDescription': "This study will evaluate whether using lower doses of contrast dye leads to lower rates of kidney injury compared to current standard of care. In particular, effort will be taken to maintain the total amount of contrast dye below a scientifically-validated threshold calculated on the basis of each participant renal function. Participants will already be scheduled to undergo a PCI. Because a smaller amount of contrast dye will be used, an intravascular ultrasound (IVUS) will be used to help the doctors see and open the blockages in participant's coronary arteries. IVUS is already used to optimize PCI results, but will be used more extensively in this case. The amount of contrast dye received will be tailored on each participant kidney function. Prospectively enrolled patients will be matched with historical controls who underwent PCI with non-intravascular imaging based approach."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled to undergo a PCI.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive patients undergoing elective and urgent (i.e., non-emergent) PCI\n* Age \\>18 years\n* eGFR \\<60 ml/min/1.73 m2\n* Angina or equivalent and/or documentation of inducible myocardial ischemia\n* Presence of =1 coronary stenosis, evaluated \\>70% by visual estimation (on a previously performed coronary angiography) or with an FFR =0.80\n* ability to provide written informed consent\n\nExclusion Criteria:\n\n* Emergent PCI due to either hemodynamic instability, ST-elevation myocardial infarction or sudden cardiac death\n* PCI on chronic total occlusion\n* Prior PCI within 3 weeks\n* Age \\>90 years\n* Left ventricular ejection fraction \\<20%\n* Need for mechanical circulatory support\n* Pregnancy\n* Prisoners\n* Non-English speaking patients\n* Inability to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT04928092', 'acronym': 'Zero-AKI', 'briefTitle': 'A Zero Acute Kidney Injury Strategy for Percutaneous Coronary Intervention in Patients With ChronicKidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'A Zero Acute Kidney Injury (Zero-AKI) Strategy for Percutaneous Coronary Intervention in Patients With ChronicKidney Disease', 'orgStudyIdInfo': {'id': 'HM20019541'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Active research group', 'description': 'Patients undergoing intravascular imaging guided, low contrast PCI procedure as part of standard care', 'interventionNames': ['Procedure: Standard of care Ultra Low Contrast PCI']}], 'interventions': [{'name': 'Standard of care Ultra Low Contrast PCI', 'type': 'PROCEDURE', 'description': 'PCI using low amounts of contrast media which is standard of care at VCU Medical Center', 'armGroupLabels': ['Active research group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Lorenzo Azzalini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Guerbet', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}