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Micro- and Macro-Circulation in Cardiac Surgery Patients

Micro- and Macro-Circulation in Cardiac Surgery Patients

Status
Suspended
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05706545
Acronym
MiMaC
Enrollment
100
Registered
2023-01-31
Start date
2027-01-01
Completion date
2027-05-01
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Coronary Artery Bypass Graft, Surgical Aortic Valve Replacement

Keywords

autonomic nervous system, heart rate variability, cardiac surgery, major morbidities

Brief 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, 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.

Interventions

DIAGNOSTIC_TESTAcquisition of cardiovascular signals and microcirculation sidestream darkfield images

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

Sponsors

IRCCS Policlinico S. Donato
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* age \>18 yrs * indication for a cardiac surgery intervention * spontaneous sinus rhythm * informed consent

Exclusion criteria

* know autonomic nervous systems pathologies or dysfunctions * pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Prediction of major morbidities by means of the variability of cardiovascular and hemodynamics markers24 monthsStatistical model assessment; time series variability analysis

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026