Microcirculatory PerfusionDIRECT-HEARTNCT07135700
Hemodynamic Evaluation and Assessment of DIRECT myocaRdial and Sublingual Capillary Perfusion in Thoracic Surgery Patients on Cardiopulmonary Bypass
An observational study of Microcirculatory Perfusion, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Microcirculatory Perfusion
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Nov 2026to 1 Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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,
Who cannot join
- 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%
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam Univeristy Medical Center
Amsterdam, North Holland, 1105 AZ
Ufuk Baldan, MD, +31640001607, b.u.baldan@amsterdamumc.nl
About this study
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.
Read more
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.
Read the detailed description
Congruence of micro- and macrocirculation is essential in participants during the postcardiotomy period to maintain hemodynamic stability [1,2]. At the capillary (i.e. microcirculatory) level, gas and nutrient exchange occurs, while macrocirculation facilitates these exchanges by ensuring that blood flows with appropriate pressure and velocity. A mismatch in this relationship, where the capillary perfusion does not correlate with the macrocirculatory parameters, is frequently observed in patients with shock or heart failure [3,4]. This discrepancy is often caused by capillary leak or hemodilution. To date, treatment has primarily focused on correcting macroscopically observed variables or values derived from them and resulting in pressure- or flow-dependent therapies.
While sublingual capillary perfusion measurements provide systemic insights, direct myocardial capillary perfusion assessment offers a direct and regional perspective. Unlike systemic capillary beds, myocardial perfusion is directly influenced by filling pressures, such as left ventricular end-diastolic pressure (LVEDP) [5]. Impaired myocardial capillary perfusion can lead to a cascade of cardiac dysfunction, including reduced oxygen delivery, inadequate nutrient exchange and making it vulnerable to ischemia or hibernation [1].
Current literature has examined intra- and postoperative sublingual (i.e., systemic) capillary perfusion following cardiac surgery [5]. Cardiopulmonary bypass (CPB), commonly used in many types of heart surgeries, inherently disrupts capillary perfusion due to its extracorporeal nature. The use of CPB alone triggers systemic inflammation, reperfusion injury and hemodilution, leading to the accumulation of metabolic waste products, formation of free oxygen radicals and perfusion alternations [7]. Additionally, the participants undergo an invasive cardiac procedure, accompanied by anesthesia and other contributing factors that negatively impact the capillary perfusion [8]. These alterations manifest in differences in microcirculatory parameters, including total vessel density (TVD), perfused vessel density (PVD), proportion of perfused vessels (PPV), microvascular flow index (MFI), and heterogeneity index (HI) [9].
Additionally, unloading the left ventricle (LV) unloading is posited to be critical for improving myocardial circulation. LV unloading is a promising concept that theoretically could improve capillary perfusion by reducing LVEDP and hence myocardial work. LV unloading could be particularly important for heart failure patients in acute cardiogenic shock. It may help promote myocardial circulation and prevent pulmonary edema. However, there is currently no robust scientific evidence to support these benefits and remains a subject of debate and philosophical discourse within the medical community [11-13].
To address this, the investigators aim to investigate whether capillary perfusion changes induced by CPB flow alterations, measured at sublingual and myocardial sites, provide consistent results. Additionally, the investigators will assess the effect of LV unloading on the capillary perfusion. The investigators will employ a handheld IDF-microcamera to perform real-time measurements of capillary perfusion. The investigators hypothesize that during hemodynamic alternations via CPB-flow sublingual and myocardial capillary perfusion measurements will show minimal differences and correlate with each other. This would supporting the validity of sublingual capillary perfusion measurements as a reliable, non-invasive proxy for the myocardial capillary perfusion status. Furthermore, the investigators anticipate an improvement in solely myocardial of both sublingual and myocardial capillary perfusion with LV unloading. These findings will significantly advance our understanding of the interaction between macro- and microcirculatory systems, providing a foundation for the use of sublingual measurements in both clinical and research settings. Ultimately, this could simplify monitoring techniques, enhance perioperative management, and help elucidate the mechanisms underlying persistent hemodynamic instability, guiding the development of more effective strategies to optimize postoperative outcomes
- Conditions
- Microcirculatory Perfusion
- Keywords
- cardiac surgery, microcirculation, capillary perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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, |
What is being measured
The primary outcome is the main question the study is designed to answer.
TVD (Total Vessel Density)
The number of small blood vessels (< 20 μm) in a given area. (Vessel density in #/area)
Measured: 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)
Measured: Intraoperatively
PVD (Perfused Vessel Density)
The ratio of total vessel length to the length of perfused vessels. (Ratio)
Measured: Intraoperatively
MFI (Microvascular Flow Index)
A semi-quantitative measure that evaluates flow in the capillary perfusion. (Flow score)
Measured: 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)
Measured: Intraoperatively
Secondary outcomes (11)
Demographic information: Age
Reported in years.
Measured: Preoperatively
Demographic Information: Gender
Categorized as male/female/other.
Measured: Preoperatively
Demographic Information: Body Mass Index (BMI)
Calculated as weight (kg) divided by height squared (m²). Reported in kg/m²
Measured: Preoperatively
Demographic Information: Medical History
Presence or absence of pre-existing conditions, such as hypertension, diabetes, prior heart surgeries; each condition reported as a separate categorical variable (yes/no).
Measured: Preoperatively
Demographic Information: Comorbidities
Presence or absence of vascular disease other than coronary artery disease, kidney dysfunction, pulmonary disease; each as separate categorical variables.
Measured: Preoperateively
Surgical Variables: Type of Underlying Pathology
Described separately for valve regurgitation, valve stenosis, aneurysm; categorical variable.
Measured: Preoperatively
LV Unloading Variables: TVD (Total Vessel Density, # vessels per area)
Capillary perfusion parameters measured separately, as they have different units and scales, consistent with primary objectives:
Each perfusion parameter is reported separately for conditions with and without LV unloading.
Measured: Intraoperatively
LV Unloading Variables: PVD (Perfused Vessel Density, # vessels per area)
Capillary perfusion parameters measured separately, as they have different units and scales, consistent with primary objectives:
Each perfusion parameter is reported separately for conditions with and without LV unloading.
Measured: Intraoperatively
LV Unloading Variables: PPV (Proportion of Perfused Vessels, ratio)
Capillary perfusion parameters measured separately, as they have different units and scales, consistent with primary objectives:
Each perfusion parameter is reported separately for conditions with and without LV unloading.
Measured: Intraoperatively
LV Unloading Variables: MFI (Microvascular Flow Index, semi-quantitative score)
Capillary perfusion parameters measured separately, as they have different units and scales, consistent with primary objectives:
Each perfusion parameter is reported separately for conditions with and without LV unloading.
Measured: Intraoperatively
LV Unloading Variables: - HI (Heterogeneity Index, variation ratio)
Capillary perfusion parameters measured separately, as they have different units and scales, consistent with primary objectives:
Each perfusion parameter is reported separately for conditions with and without LV unloading.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start2 Nov 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microcirculatory PerfusionStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ufuk Baldan, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135700
- Sponsor's protocol ID
- DIRECT-HEART
- Acronym
- DIRECT-HEART
- Status last verified
- Oct 2026
- First submitted
- 13 Aug 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depending on the outcome
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Evaluation and Assessment of DIRECT myocaRdial and Sublingual Capillary Perfusion in Thoracic Surgery Patients on Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT07135700
- Acronym / sponsor ID
- DIRECT-HEART / DIRECT-HEART
- Conditions
- Microcirculatory Perfusion
- Keywords
- cardiac surgery, microcirculation, capillary perfusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Congruence of micro- and macrocirculation is essential in participants during the postcardiotomy period to maintain hemodynamic stability [1,2]. At the capillary (i.e. microcirculatory) level, gas and nutrient exchange occurs, while macrocirculation facilitates these exchanges by ensuring that blood flows with appropriate pressure and velocity. A mismatch in this relationship, where the capillary perfusion does not correlate with the macrocirculatory parameters, is frequently observed in patients with shock or heart failure [3,4]. This discrepancy is often caused by capillary leak or hemodilution. To date, treatment has primarily focused on correcting macroscopically observed variables or values derived from them and resulting in pressure- or flow-dependent therapies.
While sublingual capillary perfusion measurements provide systemic insights, direct myocardial capillary perfusion assessment offers a direct and regional perspective. Unlike systemic capillary beds, myocardial perfusion is directly influenced by filling pressures, such as left ventricular end-diastolic pressure (LVEDP) [5]. Impaired myocardial capillary perfusion can lead to a cascade of cardiac dysfunction, including reduced oxygen delivery, inadequate nutrient exchange and making it vulnerable to ischemia or hibernation [1].
Current literature has examined intra- and postoperative sublingual (i.e., systemic) capillary perfusion following cardiac surgery [5]. Cardiopulmonary bypass (CPB), commonly used in many types of heart surgeries, inherently disrupts capillary perfusion due to its extracorporeal nature. The use of CPB alone triggers systemic inflammation, reperfusion injury and hemodilution, leading to the accumulation of metabolic waste products, formation of free oxygen radicals and perfusion alternations [7]. Additionally, the participants undergo an invasive cardiac procedure, accompanied by anesthesia and other contributing factors that negatively impact the capillary perfusion [8]. These alterations manifest in differences in microcirculatory parameters, including total vessel density (TVD), perfused vessel density (PVD), proportion of perfused vessels (PPV), microvascular flow index (MFI), and heterogeneity index (HI) [9].
Additionally, unloading the left ventricle (LV) unloading is posited to be critical for improving myocardial circulation. LV unloading is a promising concept that theoretically could improve capillary perfusion by reducing LVEDP and hence myocardial work. LV unloading could be particularly important for heart failure patients in acute cardiogenic shock. It may help promote myocardial circulation and prevent pulmonary edema. However, there is currently no robust scientific evidence to support these benefits and remains a subject of debate and philosophical discourse within the medical community [11-13].
To address this, the investigators aim to investigate whether capillary perfusion changes induced by CPB flow alterations, measured at sublingual and myocardial sites, provide consistent results. Additionally, the investigators will assess the effect of LV unloading on the capillary perfusion. The investigators will employ a handheld IDF-microcamera to perform real-time measurements of capillary perfusion. The investigators hypothesize that during hemodynamic alternations via CPB-flow sublingual and myocardial capillary perfusion measurements will show minimal differences and correlate with each other. This would supporting the validity of sublingual capillary perfusion measurements as a reliable, non-invasive proxy for the myocardial capillary perfusion status. Furthermore, the investigators anticipate an improvement in solely myocardial of both sublingual and myocardial capillary perfusion with LV unloading. These findings will significantly advance our understanding of the interaction between macro- and microcirculatory systems, providing a foundation for the use of sublingual measurements in both clinical and research settings. Ultimately, this could simplify monitoring techniques, enhance perioperative management, and help elucidate the mechanisms underlying persistent hemodynamic instability, guiding the development of more effective strategies to optimize postoperative outcomes
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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, |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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,
Key exclusion criteria (5 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
TVD (Total Vessel Density)
Time frame: Intraoperatively
The number of small blood vessels (< 20 μm) in a given area. (Vessel density in #/area)
PVD (Perfused Vessel Density)
Time frame: Intraoperatively
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)
PVD (Perfused Vessel Density)
Time frame: Intraoperatively
The ratio of total vessel length to the length of perfused vessels. (Ratio)
MFI (Microvascular Flow Index)
Time frame: Intraoperatively
A semi-quantitative measure that evaluates flow in the capillary perfusion. (Flow score)
HI (Heterogenity Index)
Time frame: Intraoperatively
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)
11 secondary outcomes
Demographic information: Age
Time frame: Preoperatively
Demographic Information: Gender
Time frame: Preoperatively
Demographic Information: Body Mass Index (BMI)
Time frame: Preoperatively
Demographic Information: Medical History
Time frame: Preoperatively
Demographic Information: Comorbidities
Time frame: Preoperateively
Surgical Variables: Type of Underlying Pathology
Time frame: Preoperatively
LV Unloading Variables: TVD (Total Vessel Density, # vessels per area)
Time frame: Intraoperatively
LV Unloading Variables: PVD (Perfused Vessel Density, # vessels per area)
Time frame: Intraoperatively
LV Unloading Variables: PPV (Proportion of Perfused Vessels, ratio)
Time frame: Intraoperatively
LV Unloading Variables: MFI (Microvascular Flow Index, semi-quantitative score)
Time frame: Intraoperatively
LV Unloading Variables: - HI (Heterogeneity Index, variation ratio)
Time frame: Intraoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Undecided. Depending on the outcome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microcirculatory Perfusion, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bahaeddin Ufuk Baldan, DR MD (+31640001607, b.u.baldan@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TVD (Total Vessel Density) (time frame: Intraoperatively). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.