Dynamic Cardio-vascular, Cerebro-vascular and Cortical Interaction in Healthy Adult Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active standing.
- Who it may be relevant to
- Registry conditions: Cardiac Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Dynamic Cardio-, Cerebro-vascular and Cortical Interaction in Healthy Adult Subjects
Overview
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.
Interventions
- 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
Primary outcome measures
- Autoregulation index (ARI) [Time frame: 36 months]
- Baroreflex sensitivity [Time frame: 36 months]
- Cortical activity [Time frame: 36 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Italy · 1 center
- IRCCS Policlinico San Donato — San Donato Milanese
Identifiers
NCT: NCT06785181 · IDEALE · 394