Ischemic Heart DiseasesNCT07833774
AI-enhanced Heart MRI for Evaluating Blood Flow
An observational study of Ischemic Heart Diseases, run by IRCCS San Raffaele.
Trial summary
This study will compare the standard MRI protocol with an advanced MRI protocol for the assessment of ischemic heart disease. The goal is to evaluate whether the advanced protocol provides comparable or improved diagnostic performance relative to the standard approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Diseases
- What is being tested?
- Accelerated advanced MRI sequences protocol
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Aug 2029
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Consecutive adults attending the U.O Advanced Imaging for Personalized Medicine to be submitted to stress cardiac MRI study
Who may be able to join
- Consecutive adults (≥18 y.o.) admitted to the UO for cardiac MRI with or without stress
Who cannot join
- Refused to consent
- Claustrophobia
- Metal prosthesis potentially affecting image quality
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: High-resolution AI-Driven Whole-Heart Perfusion MRI
This study will compare the standard MRI protocol with an advanced MRI protocol for the assessment of ischemic heart disease. The goal is to evaluate whether the advanced protocol provides comparable or improved diagnostic performance relative to the standard approach.
- Conditions
- Ischemic Heart Diseases
- Being tested
- Accelerated advanced MRI sequences protocol
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated advanced MRI sequences protocolDiagnostic test
The accelerated advanced MRI sequences will be compared with standard MRI sequences to evaluate their relative efficiency.
What is being measured
The primary outcome is the main question the study is designed to answer.
Noninferiority of accelerated advanced MRI sequences compared to standard MRI sequences, assessed using a paired Wilcoxon signed-rank test at a one-sided significance level of 0.025.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseasesStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Esposito, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833774
- Sponsor's protocol ID
- HARP-AI
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-resolution AI-Driven Whole-Heart Perfusion MRI
- ClinicalTrials.gov ID
- NCT07833774
- Acronym / sponsor ID
- HARP-AI
- Conditions
- Ischemic Heart Diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 22 Sep 2026 (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.
This study will compare the standard MRI protocol with an advanced MRI protocol for the assessment of ischemic heart disease. The goal is to evaluate whether the advanced protocol provides comparable or improved diagnostic performance relative to the standard approach.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive adults attending the U.O Advanced Imaging for Personalized Medicine to be submitted to stress cardiac MRI study
Key inclusion criteria (1 listed)
- Consecutive adults (≥18 y.o.) admitted to the UO for cardiac MRI with or without stress
Key exclusion criteria (3 listed)
- Refused to consent
- Claustrophobia
- Metal prosthesis potentially affecting 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 |
|---|---|---|
| Accelerated advanced MRI sequences protocolThe accelerated advanced MRI sequences will be compared with standard MRI sequences to evaluate their relative efficiency. | Diagnostic test | – |
Primary outcome
Noninferiority of accelerated advanced MRI sequences compared to standard MRI sequences, assessed using a paired Wilcoxon signed-rank test at a one-sided significance level of 0.025.
Time frame: 3 years
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 22 Sep 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Diseases, run by IRCCS San Raffaele.
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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Project manager (+390226438047, kavodnik.ekaterina@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Noninferiority of accelerated advanced MRI sequences compared to standard MRI sequences, assessed using a paired Wilcoxon signed-rank test at a one-sided significance level of 0.025. (time frame: 3 years). 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 22 Sep 2026.