Cardiac SurgeryMiMaCNCT05706545
Micro- and Macro-Circulation in Cardiac Surgery Patients
An observational study of Cardiac Surgery and Coronary Artery Bypass Graft, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial summary
The hypothesis under the study is that there could be a link between a dysfunction in peripheral microcirculation, sublingual microcirculation or cardiovascular control and the development of post cardiac surgery major morbidities (stroke, acute kidney injury, prolonged intubation, mediastinitis, surgical reopening… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Coronary Artery Bypass Graft, Surgical Aortic Valve Replacement
- What is being tested?
- Acquisition of cardiovascular signals and microcirculation sidestream darkfield images
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2027to May 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 consecutive patients scheduled for major cardiac surgery
Who may be able to join
- age >18 yrs
- indication for a cardiac surgery intervention
- spontaneous sinus rhythm
- informed consent
Who cannot join
- know autonomic nervous systems pathologies or dysfunctions
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The hypothesis under the study is that there could be a link between a dysfunction in peripheral microcirculation, sublingual microcirculation or cardiovascular control and the development of post cardiac surgery major morbidities (stroke, acute kidney injury, prolonged intubation, mediastinitis, surgical reopening, death).
The state of sublingual microcirculation, of peripheral microcirculation and cardiovascular control will be assessed in 100 patients undergoing cardiac surgery during general anesthesia before the intervention and at the end of the intervention at the arrival in post-surgery ICU by means of signal processing techniques.
The extracted markers will be used to assess a statistical prediction model of major morbidities.
- Being tested
- Acquisition of cardiovascular signals and microcirculation sidestream darkfield images
- Keywords
- autonomic nervous system, heart rate variability, cardiac surgery, major morbidities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acquisition of cardiovascular signals and microcirculation sidestream darkfield imagesDiagnostic test
ECG, arterial pressure and peripheral flow velocity via a percutaneous laser doppler will be acquired together with images of the sublingual microcirculation detected with sidestream darkfield images microscope
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of major morbidities by means of the variability of cardiovascular and hemodynamics markers
Statistical model assessment; time series variability analysis
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study startJan 2027 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Why it stopped: Due to some problems in instrumentation acquisition the project has been currently suspended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vlasta Bari, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706545
- Sponsor's protocol ID
- MiMaC
- Acronym
- MiMaC
- Status last verified
- Jul 2026
- First submitted
- 23 Jan 2023
- Last updated
- 7 Jul 2026
- 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 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro- and Macro-Circulation in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT05706545
- Acronym / sponsor ID
- MiMaC / MiMaC
- Keywords
- autonomic nervous system, heart rate variability, cardiac surgery, major morbidities
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Due to some problems in instrumentation acquisition the project has been currently suspended.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 31 Jan 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 hypothesis under the study is that there could be a link between a dysfunction in peripheral microcirculation, sublingual microcirculation or cardiovascular control and the development of post cardiac surgery major morbidities (stroke, acute kidney injury, prolonged intubation, mediastinitis, surgical reopening, death).
The state of sublingual microcirculation, of peripheral microcirculation and cardiovascular control will be assessed in 100 patients undergoing cardiac surgery during general anesthesia before the intervention and at the end of the intervention at the arrival in post-surgery ICU by means of signal processing techniques.
The extracted markers will be used to assess a statistical prediction model of major morbidities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 consecutive patients scheduled for major cardiac surgery
Key inclusion criteria (4 listed)
- age >18 yrs
- indication for a cardiac surgery intervention
- spontaneous sinus rhythm
- informed consent
Key exclusion criteria (2 listed)
- know autonomic nervous systems pathologies or dysfunctions
- pregnancy
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 |
|---|---|---|
| Acquisition of cardiovascular signals and microcirculation sidestream darkfield imagesECG, arterial pressure and peripheral flow velocity via a percutaneous laser doppler will be acquired together with images of the sublingual microcirculation detected with sidestream darkfield images microscope | Diagnostic test | – |
Primary outcome
Prediction of major morbidities by means of the variability of cardiovascular and hemodynamics markers
Time frame: 24 months
Statistical model assessment; time series variability analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- 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 Cardiac Surgery and Coronary Artery Bypass Graft, run by IRCCS Policlinico S. Donato at 1 site in Italy.
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 4 inclusion and 2 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: paused, as of the sponsor's last update on 7 Jul 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 Italy. 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?
Results are not available in the source record.
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?
Prediction of major morbidities by means of the variability of cardiovascular and hemodynamics markers (time frame: 24 months). 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 7 Jul 2026.