Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2025-12-25 @ 10:59 PM
Study NCT ID:
NCT06986967
Status:
RECRUITING
Last Update Posted:
2025-08-15
First Post:
2025-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrograde Versus Antegrade Perfusion in Low-Moderate Hypothermia for Aortic Arch Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The neuroimaging personnel will be blinded to the assignment of the subject.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2025-04-29', 'studyFirstSubmitQcDate': '2025-05-22', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in neurocognitive function as measured by the Montreal Cognitive Assessment (MoCA)', 'timeFrame': 'Baseline to 4 weeks', 'description': 'The MoCA is a brief screening tool used to assess cognitive function. It consists of 30 tasks covering various cognitive domains, including attention, memory, visuospatial abilities, and executive function. The total score ranges from 0 to 30, where a higher score indicates better cognitive function.'}], 'secondaryOutcomes': [{'measure': 'Effect of Antegrade Perfusion (ACP) vs Retrograde Perfusion (RCP) on brain white matter patency', 'timeFrame': 'Baseline, prior to discharge from hospital (up to 7 days), and at 4 weeks', 'description': 'Measured by MRI at baseline, prior to discharge, and at 4 weeks.'}, {'measure': 'Effect of Antegrade Perfusion (ACP) vs Retrograde Perfusion (RCP) on functional connectivity', 'timeFrame': 'Baseline and at 4 weeks', 'description': 'Measured by MRI at baseline and at 4 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Antegrade Perfusion', 'Retrograde Perfusion', 'Brain Perfusion', 'Circulatory Arrest'], 'conditions': ['Brain Function', 'Hemiarch Cardiac Procedure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare brain function after surgical circulatory arrest using either antegrade perfusion or retrograde perfusion.', 'detailedDescription': 'The purpose of this study is to compare brain function after surgical circulatory arrest (surgeon stops the heart-lung machine to work on the heart) in antegrade perfusion versus retrograde perfusion. There are 2 ways to supply blood to the brain, antegrade and retrograde perfusion. In antegrade perfusion, the surgeon accesses one of two arteries that branch off from the aorta (the artery that delivers blood to the rest of the body) to provide blood to the brain. In retrograde perfusion, the surgeon accesses the superior vena cava (large vein bringing blood back to the heart) to supply blood to the brain.\n\nIt is standard practice to cool the patient down during this type of surgery to help protect the brain. Despite measures to safeguard brain health, some patients still experience postoperative cognitive decline such as confusion, delirium and agitation. The investigators are conducting this study to see which method of perfusing the brain is superior and decreases the symptoms of confusion, delirium and agitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. \\> 18 years of age\n2. Participant's that are scheduled for elective proximal aortic reconstructive surgery (ascending aorta + aortic valve or root) with concomitant proximal hemi-arch replacement via median sternotomy\n\nExclusion Criteria:\n\n1. \\< 18 years of age\n2. history of symptomatic cerebrovascular disease, e.g., prior stroke with residual deficit\n3. current alcoholism (\\> 2 drinks/day)\n4. current psychiatric illness requiring pharmacotherapy\n5. current drug abuse (any illicit drug use in the past 3 months)\n6. hepatic insufficiency (liver function tests \\> 1.5 times the upper limit of normal)\n7. severe pulmonary insufficiency (requiring home oxygen therapy)\n8. renal failure (serum creatinine \\> 2.0 mg/dL)\n9. claustrophobic fear\n10. unable to read and thus unable to complete the cognitive testing\n11. pregnant women\n12. patients who score \\<19 om the Montreal Cognitive Assessment (MoCA) or ≥27 on the baseline Center for Epidemiological Studies Depression (CES-D) scale\n13. patients who have pre-existing unsafe implants for 3 Tesla magnetic resonance imaging (MRI)\n14. Patients who have received chemotherapy in the last 12 months or radiation to the brain"}, 'identificationModule': {'nctId': 'NCT06986967', 'acronym': 'ACP vs RCP', 'briefTitle': 'Retrograde Versus Antegrade Perfusion in Low-Moderate Hypothermia for Aortic Arch Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Retrograde Versus Antegrade Perfusion in Low-Moderate Hypothermia for Aortic Arch Surgery', 'orgStudyIdInfo': {'id': 'Pro00116844'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1: Antegrade Perfusion', 'description': 'In antegrade perfusion, the surgeon accesses one of two arteries that branch off from the aorta (the artery that delivers blood to the rest of the body) to provide blood to the brain.', 'interventionNames': ['Procedure: Antegrade Perfusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2: Retrograde Perfusion', 'description': 'In retrograde perfusion, the surgeon accesses the superior vena cava (large vein bringing blood back to the heart) to supply blood to the brain.', 'interventionNames': ['Procedure: Retrograde Perfusion']}], 'interventions': [{'name': 'Antegrade Perfusion', 'type': 'PROCEDURE', 'description': 'Procedure in which the surgeon accesses one of two arteries that branch off from the aorta to provide blood to the brain.', 'armGroupLabels': ['Arm 1: Antegrade Perfusion']}, {'name': 'Retrograde Perfusion', 'type': 'PROCEDURE', 'description': 'Procedure in which the surgeon accesses the superior vena cava to supply blood to the brain.', 'armGroupLabels': ['Arm 2: Retrograde Perfusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kelly Rodden, BSN', 'role': 'CONTACT', 'email': 'Kelly.Rodden@duke.edu', 'phone': '919-681-1804'}], 'facility': 'Duke Univeristy', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kelly Dr. Mathew, MD', 'role': 'CONTACT', 'email': 'joseph.mathew@duke.edu', 'phone': '919-681-1804'}], 'facility': 'Duke Univeristy', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'centralContacts': [{'name': 'Kelly Rodden, BSN', 'role': 'CONTACT', 'email': 'Kelly.Rodden@duke.edu', 'phone': '9196811804'}, {'name': 'Bonita Hilliard, RPM', 'role': 'CONTACT', 'email': 'bonita.hilliard@duke.edu'}], 'overallOfficials': [{'name': 'Joseph Mathew, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}