NCT06986967 Retrograde Versus Antegrade Perfusion in Low-Moderate Hypothermia for Aortic Arch Surgery
| NCT ID | NCT06986967 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Brain Function |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-04-18 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-04-18 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to compare brain function after surgical circulatory arrest using either antegrade perfusion or retrograde perfusion.
Eligibility Criteria
Inclusion Criteria: 1. \> 18 years of age 2. 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 Exclusion Criteria: 1. \< 18 years of age 2. history of symptomatic cerebrovascular disease, e.g., prior stroke with residual deficit 3. current alcoholism (\> 2 drinks/day) 4. current psychiatric illness requiring pharmacotherapy 5. current drug abuse (any illicit drug use in the past 3 months) 6. hepatic insufficiency (liver function tests \> 1.5 times the upper limit of normal) 7. severe pulmonary insufficiency (requiring home oxygen therapy) 8. renal failure (serum creatinine \> 2.0 mg/dL) 9. claustrophobic fear 10. unable to read and thus unable to complete the cognitive testing 11. pregnant women 12. patients who score \<19 om the Montreal Cognitive Assessment (MoCA) or ≥27 on the baseline Center for Epidemiological Studies Depression (CES-D) scale 13. patients who have pre-existing unsafe implants for 3 Tesla magnetic resonance imaging (MRI) 14. Patients who have received chemotherapy in the last 12 months or radiation to the brain
Contact & Investigator
Joseph Mathew, M.D.
STUDY CHAIR
Duke University
Frequently Asked Questions
Who can join the NCT06986967 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Function. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06986967 currently recruiting?
Yes, NCT06986967 is actively recruiting participants. Contact the research team at Kelly.Rodden@duke.edu for enrollment information.
Where is the NCT06986967 trial being conducted?
This trial is being conducted at Durham, United States, Durham, United States.
Who is sponsoring the NCT06986967 clinical trial?
NCT06986967 is sponsored by Duke University. The principal investigator is Joseph Mathew, M.D. at Duke University. The trial plans to enroll 30 participants.