- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05706545
Micro- and Macro-Circulation in Cardiac Surgery Patients (MiMaC)
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 Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Vlasta Bari, PhD
- Phone Number: +390252774381
- Email: vlasta.bari@grupposandonato.it
Study Locations
-
-
Milan
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San Donato Milanese, Milan, Italy, 20097
- IRCCS Policlinico San Donato
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MiMaC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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