Microvascular RarefactionNCT05728047
Evaluation of Systemic Microcirculation of Patients Undergoing Heart Valve Surgery
An observational study of Microvascular Rarefaction and Heart Valve Diseases, run by National Institute of Cardiology, Laranjeiras, Brazil at 1 site in Brazil.
Trial summary
The study aims to study the systemic microcirculation in adult patients hospitalized at a quaternary public hospital during the preoperative and immediate postoperative periods of heart valve surgery and correlations to their clinical and laboratory outcomes in the postoperative period. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Microvascular Rarefaction, Heart Valve Diseases, Extracorporeal Circulation
- What is being tested?
- Evaluation of sublingual microcirculation with side-stream dark field imaging (cytocam)
- Type of treatment
- Surgery or procedure
- How many people
- 31 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Sep 2022to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients scheduled to heart valve surgery under cardiopulmonary bypass.
Who may be able to join
- Patients scheduled to heart valve surgery under cardiopulmonary bypass.
Who cannot join
- Patients operated on for infective endocarditis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Systemic Microcirculation During the Preoperative and Early Postoperative Periods of Patients Undergoing Heart Valve Surgery
The study aims to study the systemic microcirculation in adult patients hospitalized at a quaternary public hospital during the preoperative and immediate postoperative periods of heart valve surgery and correlations to their clinical and laboratory outcomes in the postoperative period.
Read the detailed description
Despite the development of new endovascular procedures in recent years, cardiac surgery currently remains an important instrument in the management of patients with severe heart diseases, such as hemodynamically significant coronary obstructions and valve pathologies.
Despite the advances in the management of patients in intensive care, the postoperative period of patients undergoing cardiac surgery remains a challenge due to the intense inflammatory reaction triggered by the surgical procedure itself and exacerbated by the use of cardiopulmonary bypass (CPB), fundamental in most cardiac surgeries performed nowadays.
In this context, cardiac surgery for the treatment of valve pathologies with the use of CPB is more related to unfavorable clinical outcomes in the postoperative period in relation to coronary artery bypass grafting (CABG). It is postulated, as a causal factor, the longer CPB time in valve surgeries associated with more prominent cardiac morphological changes in these patients.
Studies carried out in recent years in patients hospitalized in intensive care that developed a severe inflammatory reaction, either due to sepsis, surgical procedure or more recently due to the Covid-19 pandemic, have shown a frequent dissociation between the hemodynamic findings measured in the ICU with the data of the patients' systemic microcirculation.
The use of portable microscopes has allowed the measurement of systemic microcirculation at the bedside in intensive care, enabling prompt assessment of aspects related to tissue perfusion, thus seeking to improve clinical outcomes in these patients.
- Being tested
- Evaluation of sublingual microcirculation with side-stream dark field imaging (cytocam)
- Keywords
- microcirculation, capillary density
- Medical subject headings
- Microvascular Rarefaction, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of sublingual microcirculation with side-stream dark field imaging (cytocam)Procedure or surgery
The 'Cytocam' is a hand held computer-controlled device, a third generation video-microscope, which enables real time visualisation of the in vivo microcirculation, based upon the principle of incident dark field (IDF) illumination.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of systemic microcirculation
Number of capillaries in the sublingual microcirculation.
Measured: Change of microvascular density between the preoperative and up to four hours in the postoperative period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start10 Sep 2022
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microvascular RarefactionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Laranjeiras, Brazil
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728047
- Sponsor's protocol ID
- CAAE 60999822.3.0000.5272
- Status last verified
- May 2025
- First submitted
- 17 Jan 2023
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Systemic Microcirculation During the Preoperative and Early Postoperative Periods of Patients Undergoing Heart Valve Surgery
- ClinicalTrials.gov ID
- NCT05728047
- Acronym / sponsor ID
- CAAE 60999822.3.0000.5272
- Keywords
- microcirculation, capillary density
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- National Institute of Cardiology, Laranjeiras, BrazilOther government
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 14 Feb 2023 (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.
The study aims to study the systemic microcirculation in adult patients hospitalized at a quaternary public hospital during the preoperative and immediate postoperative periods of heart valve surgery and correlations to their clinical and laboratory outcomes in the postoperative period.
Detailed description
Despite the development of new endovascular procedures in recent years, cardiac surgery currently remains an important instrument in the management of patients with severe heart diseases, such as hemodynamically significant coronary obstructions and valve pathologies.
Despite the advances in the management of patients in intensive care, the postoperative period of patients undergoing cardiac surgery remains a challenge due to the intense inflammatory reaction triggered by the surgical procedure itself and exacerbated by the use of cardiopulmonary bypass (CPB), fundamental in most cardiac surgeries performed nowadays.
In this context, cardiac surgery for the treatment of valve pathologies with the use of CPB is more related to unfavorable clinical outcomes in the postoperative period in relation to coronary artery bypass grafting (CABG). It is postulated, as a causal factor, the longer CPB time in valve surgeries associated with more prominent cardiac morphological changes in these patients.
Studies carried out in recent years in patients hospitalized in intensive care that developed a severe inflammatory reaction, either due to sepsis, surgical procedure or more recently due to the Covid-19 pandemic, have shown a frequent dissociation between the hemodynamic findings measured in the ICU with the data of the patients' systemic microcirculation.
The use of portable microscopes has allowed the measurement of systemic microcirculation at the bedside in intensive care, enabling prompt assessment of aspects related to tissue perfusion, thus seeking to improve clinical outcomes in these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to heart valve surgery under cardiopulmonary bypass.
Key inclusion criteria (1 listed)
- Patients scheduled to heart valve surgery under cardiopulmonary bypass.
Key exclusion criteria (1 listed)
- Patients operated on for infective endocarditis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of sublingual microcirculation with side-stream dark field imaging (cytocam)The 'Cytocam' is a hand held computer-controlled device, a third generation video-microscope, which enables real time visualisation of the in vivo microcirculation, based upon the principle of incident dark field (IDF) illumination. | Procedure or surgery | – |
Primary outcome
Evaluation of systemic microcirculation
Time frame: Change of microvascular density between the preoperative and up to four hours in the postoperative period.
Number of capillaries in the sublingual microcirculation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Microvascular Rarefaction and Heart Valve Diseases, run by National Institute of Cardiology, Laranjeiras, Brazil at 1 site in Brazil.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 May 2025. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of systemic microcirculation (time frame: Change of microvascular density between the preoperative and up to four hours in the postoperative period.). 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 21 May 2025.