CardioSan: Cardiovascular and Cerebrovascular Control in Healthy Subjects

• Sponsor: IRCCS Policlinico S. Donato (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05706532
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Anticipated Duration (Months): 10
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

The aim of the study is to evaluate autonomic function and cerebrovascular control in 30 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy; Autonomic Nervous System; Cerebral Autoregulation	Diagnostic Test: active standing

Study Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Cardiovascular and Cerebrovascular Control in Healthy Adult Subjects
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Healthy 30 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

Outcome Measures

Primary Outcome Measures

1. Evaluate the state and interactions of autonomic function and cerebrovascular control [12 months]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• age >18

• sinus rhythm

• informed consent signed

Exclusion Criteria:

• age <18

• presence of autonomic nervous system diseases or dysfunctions

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: NCT05706532
• Other Study ID Numbers: CardioSan
• 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; cerebral autoregulation; peripheral resistances

Study Results

No Results Posted as of Feb 2, 2023