Dynamic Cardio-vascular, Cerebro-vascular and Cortical Interaction in Healthy Adult Subjects (IDEALE)

Dynamic Cardio-, Cerebro-vascular and Cortical Interaction in Healthy Adult Subjects

IDEALE aims to assess the status of autonomic function, cerebral autoregulation (CA) and cortical activity in healthy subjects and correlate these functions with the psychological dimension of the subjects.

To this end, parameters of cardiac, cortical, vascular and cerebrovascular variability derived from electrocardiographic, electroencephalographic, respiratory movement, blood pressure, transcranial Doppler signals will be acquired and analysed for each healthy volunteer (TCD) and Laser-Doppler transcutaneous, during a phase of clinostatism (REST) and one of active orthostatism (STAND). In addition, volunteers will be submitted to psychometric tests (Chieti Affective Action Videos, CAAV) to assess the presence of depressive symptoms.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Disease
• Intervention / Treatment: Diagnostic test: Active standing

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vlasta Bari, PhD; Phone Number: +390252774381; Email: vlasta.bari@grupposandonato.it
• Study Contact Backup: Name: Pavandeep Singh; Phone Number: +390252774381; Email: pavandeep.singh@grupposandonato.it

Study Locations

• Italy
  • Milano
    • San Donato Milanese, Milano, Italy, 20097
      • Recruiting
      • IRCCS Policlinico San Donato
      • Contact: Vlasta Bari, PhD; Phone Number: 39 02 5277 4381; Email: vlasta.bari@grupposandonato.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• age older than 18 years
• spontaneous sinus rhythm
• signed informed consent

Exclusion Criteria:

• Definite diseases of the Autonomic Nervous System (SNA) or the cardiovascular system
• Central nervous system disorders
• subjects under drug therapy that may affect the cardiovascular system
• pregnancy
• previous diagnosis of depression

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: HEALTHY SUBJECTS; An experimental setup will be devised for the simultaneous monitoring and recording of EEG, ECG, AP, and R together with CBF in healthy volunteers. The experimental protocol including physiological data recordings includes three sessions lasting 10 minutes each: a session at resting state in supine position, a session during autonomic challenge obtained via active standing evoking reflex sympathetic activation, and a session of emotional elicitation via the administration of videos. The overall duration of the experiment is therefore 30 minutes. A total of 40 short video clips of the duration of 15 seconds each will be presented to a total of 50 voluteers will be recruited for the IDEALE study.

Diagnostic test: Active standing; a session at resting state in supine position, a session during autonomic challenge obtained via active standing evoking reflex sympathetic activation, and a session of emotional elicitation via the administration of videos; Other Names: Emotional tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Autoregulation index (ARI)	ARI is an index describing the state of cerebral autoregulation from mean cerebral blood velocity and mean arterial pressure. Minimum value 0, maximum value 9. ARI>4 means working autoregulation. ARI<4 means impaired autoregulation. It will be computed for all participants.	36 months
Baroreflex sensitivity	Baroreflex sensitivity will be measured in ms/mmHg. Minimum value 0. Higher value means a better baroreflex regulation. It will be computed in all participants	36 months
Cortical activity	Power of EEG in Alpha and Beta band will be measured in square microvolt. Minimum value 0.	36 months

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Donato

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2024
• Primary Completion (Estimated): October 3, 2027
• Study Completion (Estimated): October 3, 2027

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: January 17, 2025
• First Posted (Actual): March 25, 2025

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

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: IDEALE; 394 (Other Identifier: IRCCS Policlinico San Donato)

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