Using preoperative chest CT imaging to improve outcomes in aortic valve replacement surgery
Preoperative Chest CT-imaging in Surgical Aortic Valve Replacement with or Without CABG: a Randomized Controlled Trial
This study is testing if using special chest scans before aortic valve surgery can help prevent silent strokes and improve recovery for patients with severe aortic valve problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 380 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Antonius Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Nieuwegein, Utrecht) |
| Trial ID | NCT06603454 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of preoperative multi-slice computed tomography (MSCT) imaging in patients undergoing surgical aortic valve replacement (SAVR) with or without coronary artery bypass grafting (CABG). The study aims to determine if identifying atherosclerosis of the ascending aorta through MSCT can reduce the rate of subclinical strokes, as detected by diffusion-weighted magnetic resonance imaging (DW-MRI). It is a prospective, multicenter, open-label randomized controlled trial that includes patients aged 18 and older who are symptomatic with severe aortic valve stenosis. The trial will assess various outcomes, including neurological assessment scores, clinical stroke rates, and overall quality of life improvements.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with symptomatic severe aortic valve stenosis who are accepted for SAVR with or without CABG.
Not a fit: Patients who have previously undergone aortic valve replacement, are in emergency situations, or have contraindications for MRI or contrast use may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of perioperative strokes and improve overall patient outcomes during aortic valve replacement surgeries.
How similar studies have performed: While the use of MSCT in transcatheter aortic valve replacement (TAVR) has shown success, this specific application in SAVR is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Primary symptomatic severe aortic valve stenosis (defined as an aortic valve area of \<1.0cm2 and either a mean valve gradient of at least 40mmHg or a peak velocity of at least 4.0 m/s) * Accepted for SAVR (either planned to be done by a limited access approach (partial J-shaped sternotomy or right anterior thoracotomy or conventional median sternotomy approach at the preference of the patient and/or the discretion of the surgeon) with or without concomitant CABG by the Heart Team * Informed consent Exclusion Criteria: * Previous aortic valve replacement * Emergency procedure * Pregnant women * Renal failure (eGFR \<30 ml/min.) * Known contrast allergy * Patient unwilling to be informed about unrequested findings on the CT scan or DW-MRI scan * Contra-indication for MRI (e.g. permanent pacemaker or ICD that can not be inactivated per order of the pacemaker or ICD technician, morphine or insulin pump, neurostimulator). All patients will fill out a MRI checklist to additionally check for (new) safety contra-indications for MRI. * Patient who did not agree to the informed consent and/or refused to participate * Patient unable to understand the informed consent/study
Where this trial is running
Nieuwegein, Utrecht
- St. Antonius Hospital — Nieuwegein, Utrecht, Netherlands (Recruiting)
Study contacts
- Principal investigator: Patrick Klein, MD, PhD — St. Antonius Hospital
- Study coordinator: Romy Hegeman, MD
- Email: r.hegeman@antoniusziekenhuis.nl
- Phone: +31 (0)6 41 71 16 79
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.