Heart and tongue microcirculation during heart surgery with bypass
Official title: Hemodynamic Evaluation and Assessment of DIRECT myocaRdial and Sublingual Capillary Perfusion in Thoracic Surgery Patients on Cardiopulmonary Bypass
Run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT07135700 · Data updated 2026-11-12
This study tests whether measurements of tiny blood vessels under the tongue reflect heart microcirculation in adults after valve surgery or aorta repair on bypass.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam, North Holland) |
| Status | Recruiting |
| Started | November 2, 2026 |
| Main results expected | June 1, 2028 |
| Study ends | October 1, 2029 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07135700 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) undergoing CPB-assisted valve surgery or supracoronary ascending aorta replacement with good cardiac function and specific anatomical/volume criteria.
✕Probably not a fit
Patients with significant coronary disease, regional wall motion abnormalities, atrial fibrillation, or high surgical risk may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to compare microcirculatory perfusion in the heart with that in the sublingual region during the postcardiotomy period in adults undergoing CPB-assisted valve surgery or ascending aorta replacement. The team uses a specialized microscopy technique to assess capillary blood flow directly on the heart and noninvasively under the tongue. By examining congruence between microcirculation and macrocirculation, the study seeks to understand how small-vessel perfusion relates to overall hemodynamic stability after cardiac surgery. Findings could inform how microcirculatory status is monitored and potentially guide perioperative management. The study is conducted at Amsterdam University Medical Center and is led by Academisch Medisch Centrum (AMC-UvA).
Why it matters
Potential benefit: If successful, it could provide a less invasive proxy for heart microcirculation using tongue measurements to help guide postoperative care.
How similar studies have gone: Previous work has explored sublingual microcirculation after cardiac surgery; direct myocardial microcirculation assessment is less established but conceptually builds on existing microcirculation research.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (18 years or older) * Use of central cannulated CPB through median sternotomy * Patients undergoing valve surgery or a supracoronary ascending aorta replacement * Good LVEF and RVF * LAVI \< 50 ml/m2, and right atrial volume index (RAVI) \< 45 ml/m2, Exclusion Criteria: * Patients with significant coronary artery disease (i.e., CAD-RADS ≥ 4, and/or stenosis of ≥ 70% as observed in coronary angiogram) or previous infarctions, including ST-elevated myocardial ischemia (STEMI) or non-ST-elevated myocardial ischemia (N-STEMI) * Patients with echocardiographically observed regional wall motion abnormalities, hypokinesis, or akinesis in the coronary territories * Patients undergoing left atrial appendage amputation (LAAA) * Patients with AF * High-risk patients, as defined by a EuroSCORE II ≥ 8%
Where it's running
-
Amsterdam Univeristy Medical Center
Amsterdam, North Holland, Netherlands Recruiting
Study contacts
- Study coordinator: Bahaeddin Ufuk Baldan, DR MD
- Email: b.u.baldan@amsterdamumc.nl
- Phone: +31640001607
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.