MiMaC: Micro- and Macro-Circulation in Cardiac Surgery Patients

• Sponsor: IRCCS Policlinico S. Donato (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05706545
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 26
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Surgery; Coronary Artery Bypass Graft; Surgical Aortic Valve Replacement	Diagnostic Test: Acquisition of cardiovascular signals and microcirculation sidestream darkfield images

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Micro- and Macro-Circulation in Cardiac Surgery Patients
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2025
• Anticipated Study Completion Date: May 1, 2025

Outcome Measures

Primary Outcome Measures

1. Prediction of major morbidities by means of the variability of cardiovascular and hemodynamics markers [24 months]

   Statistical model assessment; time series variability analysis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vlasta Bari	San Donato Milanese	Milan	Italy	20097

Sponsors and Collaborators

• IRCCS Policlinico S. Donato

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vlasta Bari, Assistant Professor, PhD, IRCCS Policlinico S. Donato
• ClinicalTrials.gov Identifier: NCT05706545
• Other Study ID Numbers: MiMaC
• First Posted: Jan 31, 2023
• Last Update Posted: Feb 2, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Vlasta Bari, Assistant Professor, PhD, IRCCS Policlinico S. Donato: autonomic nervous system; heart rate variability; cardiac surgery; major morbidities

Study Results

No Results Posted as of Feb 2, 2023