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
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