Recruiting

Antegrade & Retrograde

Sponsor:

Duke University

Code:

NCT06986967

Conditions

Brain Function

Hemiarch Cardiac Procedure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Antegrade Perfusion

Retrograde Perfusion

Study Details

Brief summary:

The purpose of this study is to compare brain function after surgical circulatory arrest using either antegrade perfusion or retrograde perfusion.

Conditions

Brain Function

Hemiarch Cardiac Procedure

Study ID

NCT06986967

Start date

Apr 18, 2025

Status verified date

Aug, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Arm 1: Antegrade 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.

active comparator: Arm 2: Retrograde Perfusion

In retrograde perfusion, the surgeon accesses the superior vena cava (large vein bringing blood back to the heart) to supply blood to the brain.

Interventions

Antegrade Perfusion

Procedure in which the surgeon accesses one of two arteries that branch off from the aorta to provide blood to the brain.

Retrograde Perfusion

Procedure in which the surgeon accesses the superior vena cava to supply blood to the brain.

Primary outcome measure

  • Change in neurocognitive function as measured by the Montreal Cognitive Assessment (MoCA) [ Time Frame: Baseline to 4 weeks ]

Central Contacts and Locations

Central contacts

Kelly Rodden, BSN

9196811804Kelly.Rodden@duke.edu

Bonita Hilliard, RPM

bonita.hilliard@duke.edu

Locations

Duke Univeristy

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Kelly Dr. Mathew, MD

9196811804joseph.mathew@duke.edu

More Information

Sponsor

Duke University

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Keywords

  • Antegrade Perfusion
  • Retrograde Perfusion
  • Brain Perfusion
  • Circulatory Arrest

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-09-03.