Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-03-09 @ 7:21 PM
Study NCT ID:
NCT02263820
Status:
COMPLETED
Last Update Posted:
2018-08-17
First Post:
2014-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Biomarkers for Risk Prediction of Contrast-Induced Acute Kidney Injury Post Coronary Angiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Urine, plasma, buffy coat'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-15', 'studyFirstSubmitDate': '2014-10-08', 'studyFirstSubmitQcDate': '2014-10-10', 'lastUpdatePostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in serum creatinine levels (absolute and percentage)', 'timeFrame': 'Measured 48-72h after catheterization'}], 'secondaryOutcomes': [{'measure': 'Major Adverse Clinical Events (MACE, a composite of all-cause mortality, myocardial infarction or renal replacement therapy)', 'timeFrame': 'Within 90 days after catheterization'}, {'measure': 'Admission to the ICU', 'timeFrame': 'Within 90 days after catheterization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute Kidney Injury', 'Acute Renal Failure'], 'conditions': ['Acute Kidney Injury', 'Renal Insufficiency', 'Kidney Diseases']}, 'descriptionModule': {'briefSummary': 'Contrast-induced acute kidney injury (CI-AKI) has been recognized as the third most common cause of hospital acquired AKI, after hypotension-associated hypo-perfusion and post-operative AKI. The development of CI-AKI after cardiac catheterization is associated with a significant increase in both short-term and long-term mortality and morbidities, as well as an increase in length of stay and cost.\n\nThe only marker of renal function that has predictive ability is creatinine and it has significant limitations in identifying patients who will develop AKI. Therefore, a diagnostic test for predicting CI-AKI risk would have widespread clinical utility.\n\nThe primary purpose of this study is to measure the association between baseline expression of senescence markers in blood using SenesceTest and the occurrence of CI-AKI post cardiac catheterization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults undergoing cardiac catheterization with or without percutaneous coronary intervention (PCI)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (\\>18 yo) undergoing invasive coronary angiography with or without percutaneous coronary intervention (PCI), that are predicted to have ≥14% risk of developing AKI as defined by Mehran et al.\n* Medically compliant and able to consent and follow detailed directions\n* Agree to additional collection of blood sample 48-72h post cardiac catheterization\n\nExclusion Criteria:\n\n* Presence of acute, active infection (e.g. HIV, pneumonia, septic shock).\n* Contrast media exposure within last 48h\n* Presenting with systolic time-segment elevation myocardial infarction.\n* Presence of cardiogenic shock\n* Presence of hemodynamic instability or requiring pressors or intra-aortic balloon pump\n* Severe kidney disease with estimated glomerular filtration rate \\<30 mL/min/1.73m2 or receiving dialysis for end stage renal disease\n* Kidney transplant and liver transplant patients and all patients currently on immunosuppressants\n* Severe heart failure with known ejection fraction \\<25%\n* Prior heart transplant\n* Chronic liver disease /cirrhosis\n* Patients actively undergoing chemotherapy or radiation treatment for any indication.'}, 'identificationModule': {'nctId': 'NCT02263820', 'acronym': 'NORDICA', 'briefTitle': 'Novel Biomarkers for Risk Prediction of Contrast-Induced Acute Kidney Injury Post Coronary Angiography', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sapere Bio'}, 'officialTitle': 'Novel Biomarkers for Risk Prediction of Contrast-Induced Acute Kidney Injury Post Coronary Angiography (NORDICA Study)', 'orgStudyIdInfo': {'id': 'HSDX-1502'}}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Center for Heart & Vascular Care', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'George A Stouffer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sapere Bio', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}