- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05706532
Cardiovascular and Cerebrovascular Control in Healthy Subjects (CardioSan)
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
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Vlasta Bari, PhD
- Phone Number: +390252774381
- Email: vlasta.bari@grupposandonato.it
Study Locations
-
-
Milan
-
San Donato Milanese, Milan, Italy, 20097
- Recruiting
- IRCCS Policlinico San Donato
-
Contact:
- Vlasta Bari, PhD
- Phone Number: +390252774381
- Email: vlasta.bari@grupposandonato.it
-
Principal Investigator:
- Vlasta Bari, PhD
-
Sub-Investigator:
- Marco Ranucci, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- age >18
- sinus rhythm
- informed consent signed
Exclusion Criteria:
- age <18
- presence of autonomic nervous system diseases or dysfunctions
Study Plan
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.
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
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
Keywords
Other Study ID Numbers
- CardioSan
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
product manufactured in and exported from the U.S.
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