Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-26 @ 10:57 PM
Study NCT ID:
NCT03347032
Status:
COMPLETED
Last Update Posted:
2022-12-14
First Post:
2017-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remote Ischemic Preconditioning for Renal Protection in TAVI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-12', 'studyFirstSubmitDate': '2017-11-08', 'studyFirstSubmitQcDate': '2017-11-16', 'lastUpdatePostDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Renal function as a measured by serum creatinine', 'timeFrame': '48-72 hours', 'description': 'Assess the effects on post procedure renal injury. Lab work will be obtained in the form of a basic metabolic panel evaluating the creatinine level. A baseline basic metabolic panel will be obtained prior to scheduled procedure to evaluate baseline renal function and then 48-72 hours post procedure, the optimal time to see the effects of contrast induced nephropathy to evaluate the degree of acute kidney injury. The baseline and post procedure measurements of renal function will be compared between both arms of the study.'}], 'secondaryOutcomes': [{'measure': 'Clinical Outcomes', 'timeFrame': '6 months', 'description': "The patient's electronic medical record will be reviewed at 6 months post procedure. The investigators will be assessing renal function at 6 months if a creatinine (lab) was ordered by the primary provider for any reason."}, {'measure': 'Clinical Outcomes', 'timeFrame': '6 months', 'description': 'The investigators will be reviewing the medical records of participants for evidence of post procedure adverse events including death, MI, stroke and hospital readmission'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Valve Stenosis', 'Renal Insufficiency', 'Contrast-induced Nephropathy']}, 'descriptionModule': {'briefSummary': 'Severe aortic stenosis remains a major cause of morbidity and mortality of the elderly affecting approximately 3% of elderly patients with an increasing number of patients undergoing transcatheter aortic valve interventions. As part of pre-procedural planning these patients undergo CT scans and receive contrast during the procedure. These patients often have baseline renal insufficiency and are high risk of contrast induced nephropathy despite pre-hydration techniques. The purpose of this study is to evaluate the efficacy of this simple and safe procedure in preventing renal injury in this particular population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Adults aged 18 or older presenting with moderate to severe aortic stenosis for a trans-catheter aortic valve intervention\n\nExclusion Criteria:\n\n* Patients in cardiogenic shock defined as requiring circulatory or hemodynamic support with a device, vasopressors or inotropes\n* Systemic hypotension (systolic blood pressure \\< 90mmHg)\n* Patients currently on hemodialysis\n* Presence of an arteriovenous dialysis fistula or graft or lymphedema in either arm\n* Patients enrolled in other active cardiovascular investigational studies\n* Severe comorbidities with a life expectancy of less than 6 months\n* Pregnant or lactating women\n* Patients unable to provide consent\n* Patients taking the medication glibenclamide for treatment of diabetes'}, 'identificationModule': {'nctId': 'NCT03347032', 'briefTitle': 'Remote Ischemic Preconditioning for Renal Protection in TAVI', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'Remote Ischemic Preconditioning for Renal Protection in Patients Undergoing Transcatheter Aortic Valve Interventions', 'orgStudyIdInfo': {'id': 'RIPC TAVI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'This group will undergo remote ischemic preconditioning with serial inflations of the blood pressure cuff to 200 mmHg followed by deflation for reperfusion for a period of 5 minutes each for a total of 4 cycles.', 'interventionNames': ['Procedure: Remote ischemic preconditioning']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'This group will undergo serial inflations of the blood pressure cuff to 40 mmHg followed by deflation for a period of 5 minutes each for a total of 4 cycles.', 'interventionNames': ['Procedure: Control']}], 'interventions': [{'name': 'Remote ischemic preconditioning', 'type': 'PROCEDURE', 'description': 'Serial inflations and deflations as detailed in the arm/group descriptions', 'armGroupLabels': ['Intervention']}, {'name': 'Control', 'type': 'PROCEDURE', 'description': 'Serial inflations and deflations as detailed in the arm/group descriptions', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'overallOfficials': [{'name': "William O'Neill, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henry Ford Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-Investigator', 'investigatorFullName': 'Brittany Fuller, MD', 'investigatorAffiliation': 'Henry Ford Health System'}}}}