Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-02 @ 12:39 AM
Study NCT ID:
NCT05906758
Status:
RECRUITING
Last Update Posted:
2025-09-23
First Post:
2023-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultra-Low Contrast Angiography in AKI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002533', 'term': 'Cerebral Angiography'}], 'ancestors': [{'id': 'D009485', 'term': 'Neuroradiography'}, {'id': 'D059906', 'term': 'Neuroimaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D000792', 'term': 'Angiography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2023-06-07', 'studyFirstSubmitQcDate': '2023-06-07', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in incidence of Contrast Induced Nephropathy (CIN)', 'timeFrame': 'Within 7 days', 'description': 'CIN is defined as an increase in serum creatinine by 0.5mg/dl or a relative rise of 25% from the baseline value. The investigators will measure the incidence of CIN by the increase in serum creatinine to see if the incidence will be the same in both arms whether the patient received the immediate angiography or if it was delayed until kidney function has been stabilized.'}], 'secondaryOutcomes': [{'measure': 'Incidence of earlier occurrence of CIN', 'timeFrame': 'Within 7 days', 'description': 'The investigators will measure serum creatinine at 24, 48 hours and at 1 week to measure if the occurrence of CIN will happen earlier in 1 arm than the other'}, {'measure': 'Incidence of renal replacement therapy at up to 7 days post-angiography', 'timeFrame': 'Within 7 days', 'description': 'The investigators will measure the incidence of renal replacement therapy by monitoring if the patient will undergo dialysis within 7 days post angiography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary angiography', 'Ultra low contrast'], 'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the safety of ultra-low contrast coronary angiography in patients with pre-existing acute kidney injury.', 'detailedDescription': 'The study is a non-inferiority open-label randomized controlled trial. Hospitalized patients who have AKI at admission or who develop AKI during admission and require invasive coronary angiography will be included in the trial. Once indication for invasive coronary angiography is determined, patients will be randomized to immediate angiography or to delayed angiography after renal function stabilizes. Immediate angiography will be performed within 24 of enrollment. Serum creatinine will be collected on enrollment, within 6 hours before coronary angiography, and at 24h, 48h and 1-week after the angiography, as expected in common practice. Pre- and post-hydration administration will be at the discretion of the treating physician. In case percutaneous coronary intervention is indicated it will be schedule for 7 days after angiography.\n\nDefinitions: AKI is defined as an increase in serum creatinine by ≥50% from baseline within 7 days or an increase in serum creatinine by ≥0.3 mg/dl within 2 days. CIN is defined as an increase in serum creatinine by 0.5mg/dl or a relative rise of 25% from the baseline value.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized patients who have AKI at admission or who develop AKI during admission and require invasive coronary angiography will be included in the trial.\n\nExclusion Criteria:\n\n* Stabilized renal function manifested by unchanged or downtrending serum creatinine during a 24-hour period prior to enrollment.\n* Contraindication for invasive coronary angiography other than AKI.\n* Percutaneous coronary intervention is indicated and cannot be postponed by 7 days.\n* Need for renal replacement therapy before coronary angiography or planned renal replacement therapy after coronary angiography (if premeditated before coronary angiography).\n* Administration of intravascular contrast media during 7 days prior to the coronary angiography or within 6 days after coronary angiography.\n* Pregnant patients, prisoners, cognitively impaired subjects, age below 18 years, unable or unwilling to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT05906758', 'briefTitle': 'Ultra-Low Contrast Angiography in AKI', 'organization': {'class': 'OTHER', 'fullName': 'Tulane University'}, 'officialTitle': 'Randomized Controlled Trial of Ultra-Low Contrast Coronary Angiography During Acute Kidney Injury (AKI)', 'orgStudyIdInfo': {'id': '2023-874'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Immediate intervention arm', 'description': 'Immediate angiography will be performed within 24 hours of enrollment. Omnipaque contrast will be administered. Serum creatinine will be collected on enrollment, within 6 hours before coronary angiography, and at 24h, 48h and 1-week after the angiography, as expected in common practice. Pre- and post-hydration administration will be at the discretion of the treating physician. In case percutaneous coronary intervention is indicated it will be schedule for 7 days after angiography.', 'interventionNames': ['Procedure: Angiography']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Delayed intervention arm', 'description': 'Delayed angiography will be performed after kidney function stabilizes.', 'interventionNames': ['Procedure: Angiography']}], 'interventions': [{'name': 'Angiography', 'type': 'PROCEDURE', 'description': 'Coronary angiography with less than 20cc of contrast materials', 'armGroupLabels': ['Delayed intervention arm', 'Immediate intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Zach Rozenbaum, MD', 'role': 'CONTACT', 'email': 'zrozenbaum@tulane.edu', 'phone': '504-988-5493'}, {'name': 'Zach Rozenbaum, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tulane University Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Zach Rozenbaum, MD', 'role': 'CONTACT', 'email': 'zrozenbaum@tulane.edu', 'phone': '504-988-5493'}, {'name': 'Zach Rozenbaum, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}], 'centralContacts': [{'name': 'Zach Rozenbaum, MD', 'role': 'CONTACT', 'email': 'zrozenbaum@tulane.edu', 'phone': '504-988-5493'}], 'overallOfficials': [{'name': 'Zach Rozenbaum, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tulane University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tulane University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}