Cardiac Disease
Conditions
Brief summary
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_TESTActive 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
Sponsors
IRCCS Policlinico S. Donato
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Autoregulation index (ARI) | 36 months | 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. |
| Baroreflex sensitivity | 36 months | 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 |
| Cortical activity | 36 months | Power of EEG in Alpha and Beta band will be measured in square microvolt. Minimum value 0. |
Countries
Italy
Contacts
CONTACTVlasta Bari, PhD
CONTACTPavandeep Singh
Outcome results
None listed