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

NCT07135700 | Not Yet Recruiting DMC

• 1 other identifier: DIRECT-HEART
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Microcirculatory Perfusion

Keywords

cardiac surgery; microcirculation; capillary perfusion

Outcome Measures

Primary Outcomes (5)

• TVD (Total Vessel Density)

  The number of small blood vessels (\< 20 μm) in a given area. (Vessel density in #/area)

  Intraoperatively

• PVD (Perfused Vessel Density)

  The number of small blood vessels that show perfusion, defined by a flow score of 2 or higher (moderate to normal flow). (Perfusion vessel density in #/area)

  Intraoperatively

• PVD (Perfused Vessel Density)

  The ratio of total vessel length to the length of perfused vessels. (Ratio)

  Intraoperatively

• MFI (Microvascular Flow Index)

  A semi-quantitative measure that evaluates flow in the capillary perfusion. (Flow score)

  Intraoperatively

• HI (Heterogenity Index)

  The degree of variation in capillary perfusion flow between different areas, calculated as the difference between the highest and lowest MFI, divided by the average MFI. (Variation index)

  Intraoperatively

Secondary Outcomes (11)

• Demographic information: Age

  Preoperatively

• Demographic Information: Gender

  Preoperatively

• Demographic Information: Body Mass Index (BMI)

  Preoperatively

• Demographic Information: Medical History

  Preoperatively

• Demographic Information: Comorbidities

  Preoperateively

Study Arms (1)

Cardiac surgery patients

In order to be eligible to participate in this study, a participant must meet all of the following 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,

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients are selected from the surgical waiting list. Since we aim to include only elective adult patients with minimal comorbidities and a low or intermediate European System for Cardiac Operative Risk Evaluation (EuroSCORE) II (i.e., low or intermediate risk of in-hospital mortality), a significant number of patients are eligible. On our department, we perform approximately 20 cardiac surgeries per week, with valve surgeries representing a relatively large portion. The distribution of surgeries varies from week to week. However, a significant proportion of patients cannot be included due to the need for concomitant coronary revascularization or a history of such procedures

You may qualify if:

• 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,

You may not qualify if:

• 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%

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Central Study Contacts

Bahaeddin Ufuk Baldan, DR MD

CONTACT

+31640001607; b.u.baldan@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Cardiac Surgery. MD

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 22, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08