NCT07135700 Hemodynamic Evaluation and Assessment of DIRECT myocaRdial and Sublingual Capillary Perfusion in Thoracic Surgery Patients on Cardiopulmonary Bypass

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 30 participants in total. It began in 2026-11-02 with a primary completion date of 2028-06-01.

Brief Summary

After cardiac surgery, some people may experience problems with their circulation or how well the heart pumps. This can occur because the smallest blood vessels in the heart do not function properly. When these vessels don't work correctly, organs and tissues don't receive enough oxygen and nutrients, which can lead to circulatory problems and organ damage. Typically, treatments focus on improving the larger blood vessels, such as blood pressure and heart function, but the investigators don't yet know enough about the smallest blood vessels. In this study, the investigators measure blood flow using a special camera (a microscope) at two locations: under the tongue and directly on the heart. Measurements under the tongue are already performed more frequently, but measurements directly on the heart are still new. If the investigators can demonstrate that differences in cardiac blood flow can also be observed under the tongue, it will become easier to conduct research on microcirculation. The use of the device is safe, and measurements are performed under strict supervision and control by experienced physicians and researchers. Ultimately, the investigators hope to use this knowledge to better prevent or treat complications after cardiac surgery. The aim of this research is to investigate whether measurements of blood flow in the smallest blood vessels (microcirculation) on the heart provide the same information as measurements of microcirculation under the tongue. This appears to be describing a clinical study comparing sublingual and epicardial microcirculation monitoring techniques to potentially establish a less invasive method for assessing cardiac microvascular function in post-surgical patients.

Eligibility 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%

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