Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-05 @ 5:25 AM
Study NCT ID:
NCT02496234
Status:
COMPLETED
Last Update Posted:
2016-11-23
First Post:
2015-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Aging Biomarkers to Predict Adverse Outcomes After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'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'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'White blood cells Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 186}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-22', 'studyFirstSubmitDate': '2015-07-08', 'studyFirstSubmitQcDate': '2015-07-09', 'lastUpdatePostDateStruct': {'date': '2016-11-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of stage 1 or higher postoperative AKI as defined by the AKIN classification (stage 1- ≥ 0.5 mg/dL absolute or ≥ 50% relative rise in peak SCr over the baseline)', 'timeFrame': '48-72 hours'}], 'secondaryOutcomes': [{'measure': 'Number of Participants who suffered postoperative stroke', 'timeFrame': '30 days'}, {'measure': 'Number of Participants who suffered cognitive decline', 'timeFrame': '30 days'}, {'measure': 'Number of Participants requiring prolonged mechanical ventilation (for longer than 24h)', 'timeFrame': '30 days'}, {'measure': 'Number of Participants with : cardiac arrest, perioperative myocardial infarction and perioperative ventricular dysfunction.', 'timeFrame': '30 days'}, {'measure': 'Number of Participants with cardiac arrest', 'timeFrame': '30 days'}, {'measure': 'Number of Participants with perioperative myocardial infarction', 'timeFrame': '30 days'}, {'measure': 'Number of Participants with perioperative ventricular dysfunction.', 'timeFrame': '30 days'}, {'measure': 'Number of Participants with postoperative deep sternal wound infection', 'timeFrame': '30 days'}, {'measure': 'Number of Participants with postoperative thoracotomy infection', 'timeFrame': '30 days'}, {'measure': 'Number of Participants with postoperative sepsis.', 'timeFrame': '30 days'}, {'measure': 'Number of Participants in need for renal replacement therapy', 'timeFrame': '30 days'}, {'measure': 'Number of Participants who progressed to end stage renal disease.', 'timeFrame': '30 days'}, {'measure': 'Death', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coronary Artery Bypass Graft Surgery', 'Acute kidney injury', 'Renal failure', 'Biomarker'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second most common cause of hospital acquired AKI. The development of CSA-AKI is independently associated with an increased risk of in-hospital death. There are currently no biomarkers that could identify patients at higher risk for AKI and current risk predictor scores that are based on clinical and demographic information are inadequate. Therefore, a diagnostic test for predicting AKI risk in this clinical context would assist clinicians to optimize surgical strategy and postoperative care to prevent CSA-AKI occurrence and improve patient outcomes.\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 CSA-AKI post surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All subjects entered into this study will be patients of the Duke University Health System.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients must fulfill all criteria to be eligible for this study:\n\n* Adult patients (\\>18 yo) undergoing non-emergency cardiac surgery using cardiopulmonary bypass (CABG, combined CABG/valve, or valve surgery).\n\nExclusion Criteria:\n\nPatients who fulfill any of the following criteria will be excluded:\n\n* Emergency surgery.\n* Off-pump coronary bypass grafting.\n* Aortic aneurysm repair.\n* Congenital heart disease repair.\n* Heart transplant or LVAD patient.\n* Severe heart failure (LVEF\\<25%).\n* Hemodynamic instability or requiring preoperative vasopressors or IABP.\n* Pre-existing end-stage kidney disease (eGFR\\< 15 mL/min/1.73 m2) or renal transplantation.\n* Presence of major active infection (chronic or acute, e.g. sepsis, HIV, pneumonia).\n* Chronic liver disease /cirrhosis.'}, 'identificationModule': {'nctId': 'NCT02496234', 'briefTitle': 'The Use of Aging Biomarkers to Predict Adverse Outcomes After Cardiac Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sapere Bio'}, 'orgStudyIdInfo': {'id': 'HSDX-1503'}}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Mihai V Podgoreanu, MD, FASE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sapere Bio', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Duke University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}