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NCT07135700: DIRECT-HEART

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

Not yet recruiting Last updated 22 August 2025
What this trial tests

trial in Microcirculatory Perfusion in 30 participants. Not yet recruiting.

Timeline
1 October 2025
Primary endpoint
1 June 2026
1 October 2026

Quick facts

Lead sponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
StatusNot yet recruiting
Study typeOBSERVATIONAL
Enrollment30
Start date1 October 2025
Primary completion1 June 2026
Estimated completion1 October 2026

Conditions studied

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) — full company profile →

Who can join

Eligibility, any sex, with Microcirculatory Perfusion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

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