Cardiovascular DiseasesTHAITI-VNCT06855238
Clinical Validation of an Artificial Intelligence Tool to Predict Inversion Time
A study testing THAITI software in people with Cardiovascular Diseases, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
Introduction: Inversion-recovery (IR) magnetic resonance (MR) sequences are commonly used to perform late-gadolinium enhancement (LGE) imaging during cardiac magnetic resonance (CMR) scans. Inversion Time (TI), i.e. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- THAITI software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 11 Nov 2024to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients in whom CMR-LGE is performed for a clinical reason
- Mixed cardiac conditions (including cardiomyopathies, ischemic heart disease, normal scans, focal and diffuse myocardial pathological processes)
- Both sexes
- Any age
- Availability of serum creatinine, measured within one month prior to CMR
- Provision of the written informed consent
Who cannot join
- Non-contrast CMR
- First-pass perfusion stress-CMR
- Absolute contraindication to CMR
- Inadequate overall image quality
Trial locations and contacts
1 site in 1 country.
About this study
Introduction: Inversion-recovery (IR) magnetic resonance (MR) sequences are commonly used to perform late-gadolinium enhancement (LGE) imaging during cardiac magnetic resonance (CMR) scans. Inversion Time (TI), i.e. the time between the 180° inverting pulse and the 90°-pulse, must be manually input to obtain optimal myocardium nulling. Determinants of this value are patient's, sequence, and contrast characteristics, and the time after contrast injection. The identification of the correct TI is pivotal to quality images. The determination of TI is mostly based on experience, and it can be challenging in some diseases and for less experienced operators.
Aim of this study is to test in a clinical setting an Artificial Intelligence (AI) tool, which we developed to automatically predict TI in CMR post-contrast IR LGE sequences, named "THAITI".
THAITI performance will be evaluated in terms of 1) quality of images obtained using the AI-predicted TI with a 4-point Likert scale; 2) quality of images obtained using the AI-predicted TI in terms of Contrast-Enhancement ratio, i.e. the signal intensity of enhanced/remote myocardium in CMR-LGE images; 3) numbers of images that need to be reacquired; 4) average time duration of CMR-LGE imaging.
- Conditions
- Cardiovascular Diseases
- Being tested
- THAITI software
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THAITI softwareDevice
THAITI is an AI-based software which predicts on the fly personalised TI for late gadolinium enhancement imaging during cardiovascular magnetic resonance scans.
The clinical investigators will be provided by the computer scientists investigators with a software, based on the developed AI model. During the CMR in the experimental group, investigators will input patients' data on the software (e.g. age, sex, dose of contrast…). The software will provide a TI value to be input in the MRI scanner. TI will be set accordingly to the AI prediction. A LGE series of 3 long axis (4-, 2- and 3-chambers view) and a short-axis stack will be acquired.
For all the patients, a doctor expert in CMR will be at the scanner and quality check the images in real time. Every image where the myocardium is not optimally nulled will be repeated with a TI set by the CMR doctor.
| Study group | Role | What they receive |
|---|---|---|
| Operator-set TI (control group) | No intervention | During the cardiovascular magnetic resonance scan, the TI is set by an experienced human operator as per standard clinical practice |
| THAITI-set TI | Experimental | During the cardiovascular magnetic resonance scan, the TI is set by the experimental software Receives: Device: THAITI software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Images quality proportion
Proportion of images with optimal/good quality
Measured: At examination
Secondary outcomes (1)
contrast-enhancement ratio
Contrast-Enhancement ratio (CER)
Measured: At examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start11 Nov 2024
- Primary completion12 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855238
- Sponsor's protocol ID
- 09C335
- Acronym
- THAITI-V
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of an Artificial Intelligence Tool to Predict Inversion Time
- ClinicalTrials.gov ID
- NCT06855238
- Acronym / sponsor ID
- THAITI-V / 09C335
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 3 Mar 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.
Introduction: Inversion-recovery (IR) magnetic resonance (MR) sequences are commonly used to perform late-gadolinium enhancement (LGE) imaging during cardiac magnetic resonance (CMR) scans. Inversion Time (TI), i.e. the time between the 180° inverting pulse and the 90°-pulse, must be manually input to obtain optimal myocardium nulling. Determinants of this value are patient's, sequence, and contrast characteristics, and the time after contrast injection. The identification of the correct TI is pivotal to quality images. The determination of TI is mostly based on experience, and it can be challenging in some diseases and for less experienced operators.
Aim of this study is to test in a clinical setting an Artificial Intelligence (AI) tool, which we developed to automatically predict TI in CMR post-contrast IR LGE sequences, named "THAITI".
THAITI performance will be evaluated in terms of 1) quality of images obtained using the AI-predicted TI with a 4-point Likert scale; 2) quality of images obtained using the AI-predicted TI in terms of Contrast-Enhancement ratio, i.e. the signal intensity of enhanced/remote myocardium in CMR-LGE images; 3) numbers of images that need to be reacquired; 4) average time duration of CMR-LGE imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operator-set TI (control group) | No intervention | –During the cardiovascular magnetic resonance scan, the TI is set by an experienced human operator as per standard clinical practice |
| THAITI-set TI | Experimental | Device: THAITI softwareDuring the cardiovascular magnetic resonance scan, the TI is set by the experimental software |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients in whom CMR-LGE is performed for a clinical reason
- Mixed cardiac conditions (including cardiomyopathies, ischemic heart disease, normal scans, focal and diffuse myocardial pathological processes)
- Both sexes
- Any age
- Availability of serum creatinine, measured within one month prior to CMR
Key exclusion criteria (4 listed)
- Non-contrast CMR
- First-pass perfusion stress-CMR
- Absolute contraindication to CMR
- Inadequate overall image quality
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 |
|---|---|---|
| THAITI softwareTHAITI is an AI-based software which predicts on the fly personalised TI for late gadolinium enhancement imaging during cardiovascular magnetic resonance scans. The clinical investigators will be provided by the computer scientists investigators with a software, based on the developed AI model. During the CMR in the experimental group, investigators will input patients' data on the software (e.g. age, sex, dose of contrast…). The software will provide a TI value to be input in the MRI scanner. TI will be set accordingly to the AI prediction. A LGE series of 3 long axis (4-, 2- and 3-chambers view) and a short-axis stack will be acquired. For all the patients, a doctor expert in CMR will be at the scanner and quality check the images in real time. Every image where the myocardium is not optimally nulled will be repeated with a TI set by the CMR doctor. | Device | THAITI-set TI |
Primary outcome
Images quality proportion
Time frame: At examination
Proportion of images with optimal/good quality
1 secondary outcome
contrast-enhancement ratio
Time frame: At examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THAITI software in people with Cardiovascular Diseases, run by Istituto Auxologico Italiano 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 3 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Images quality proportion (time frame: At examination). 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 3 Mar 2025.