Cardiac DiseaseIDEALENCT06785181
Dynamic Cardio-vascular, Cerebro-vascular and Cortical Interaction in Healthy Adult Subjects
A study testing Active standing in people with Cardiac Disease, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Active standing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 3 Oct 2024to 3 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age older than 18 years
- spontaneous sinus rhythm
- signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Policlinico San Donato
San Donato Milanese, Milano, 20097
Vlasta Bari, PhD, 39 02 5277 4381, vlasta.bari@grupposandonato.it
About this study
Official title: 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.
- Conditions
- Cardiac Disease
- Being tested
- Active standing
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active standingDiagnostic test
Also called Emotional tests
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
| Study group | Role | What they receive |
|---|---|---|
| HEALTHY SUBJECTS | Experimental | 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. Receives: Diagnostic Test: Active standing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 36 months
Cortical activity
Power of EEG in Alpha and Beta band will be measured in square microvolt. Minimum value 0.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start3 Oct 2024
- Primary completion3 Oct 2027 (estimated)
- Study completion3 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vlasta Bari, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785181
- Sponsor's protocol ID
- IDEALE
- Other IDs
- 394
- Acronym
- IDEALE
- Status last verified
- Jul 2026
- First submitted
- 4 Nov 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Cardio-, Cerebro-vascular and Cortical Interaction in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06785181
- Acronym / sponsor ID
- IDEALE / IDEALE
- Conditions
- Cardiac Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 3 Oct 2027 (estimated)
- Study completion
- 3 Oct 2027 (estimated)
- First posted
- 21 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HEALTHY SUBJECTS | Experimental | Diagnostic Test: Active standingAn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age older than 18 years
- spontaneous sinus rhythm
- signed informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active standingAlso: Emotional testsa 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 | Diagnostic test | HEALTHY SUBJECTS |
Primary outcome
Autoregulation index (ARI)
Time frame: 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
Time frame: 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
Time frame: 36 months
Power of EEG in Alpha and Beta band will be measured in square microvolt. Minimum value 0.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active standing in people with Cardiac Disease, run by IRCCS Policlinico S. Donato at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vlasta Bari, PhD (+390252774381, vlasta.bari@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autoregulation index (ARI) (time frame: 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.