Cardiovascular and Cerebrovascular Control in Healthy Subjects (CardioSan)

March 25, 2025 updated by: Vlasta Bari, IRCCS Policlinico S. Donato

Cardiovascular and Cerebrovascular Control in Healthy Adult Subjects

The aim of the study is to evaluate autonomic function and cerebrovascular control in 60 healthy subjects by means of noninvasive analysis of time series variability.

To this extent, heart period, systolic and mean arterial blood pressure, cerebral blood velocity, peripheral resistances, respiration will be recorded from subjects during an orthostatic challenge.

The interactions between autonomic cardiovascular function, cerebrovascular and peripheral control will be evaluated exploiting the most advanced signal processing techniques.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Milan
      • San Donato Milanese, Milan, Italy, 20097
        • Recruiting
        • IRCCS Policlinico San Donato
        • Contact:
        • Contact:
          • Marco Ranucci, MD
        • Contact:
          • Vlasta Bari, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy subjects

Description

Inclusion Criteria:

  • age >18
  • sinus rhythm
  • informed consent signed

Exclusion Criteria:

  • age <18
  • presence of autonomic nervous system diseases or dysfunctions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy
60 healthy subjects; age >18; sinus rhythm; absence of autonomic diseases or dysfunctions.
Diagnostic test: active standing
Data are acquired with patients resting in supine position for 10 minutes and for 10 minutes during active standing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate the state and interactions of autonomic function and cerebrovascular control
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Donato

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2023

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

January 23, 2023

First Submitted That Met QC Criteria

January 23, 2023

First Posted (Actual)

January 31, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CardioSan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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