Cardiovascular DiseasesSMART-CCTA-1NCT06986733
Study of Management Alterations Resulting From CaRi-Heart® Technology in Patients Undergoing Coronary Computed Tomography Angiography (CCTA) for the Evaluation of Coronary Artery Disease: A United States Based Multi-Centre Study (SMART-CCTA-1)
An observational study of Cardiovascular Diseases, run by Caristo Diagnostics Limited.
Trial summary
This study is an assessment of the impact of CaRi-Heart® on the clinical management of patients across at least three centres in the USA. This study is an observational study, in which clinicians will be presented with a patient's CCTA scan results and relevant clinical details (such as blood test results and clinical… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 31 Dec 2025
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any participant who has had a clinically indicated analysable CCTA at the three hospital collaborators
Who may be able to join
- Clinically indicated CCTA undertaken for evaluation of coronary artery disease.
Who cannot join
- History of surgical revascularization (coronary artery bypass graft, CABG)
- CCTA undertaken for structural heart disease evaluation (e.g. transcatheter aortic valve replacement (TAVR)
- The CCTA is of poor quality or partly unanalyzable due to artifacts, such as motion-artifacts, breathing-artifacts, stack-artifacts or blooming-artifacts.
About this study
Official title: Study of Management Alterations Resulting From CaRi-Heart® Technology in Patients Undergoing Coronary Computed Tomography Angiography (CCTA) for the Evaluation of Coronary Artery Disease: A United States Based Multi-Centre Study
This study is an assessment of the impact of CaRi-Heart® on the clinical management of patients across at least three centres in the USA. This study is an observational study, in which clinicians will be presented with a patient's CCTA scan results and relevant clinical details (such as blood test results and clinical risk factors) with the resulting clinical management recommendation recorded; they will then be presented with the results of the CaRi-Heart® analysis alongside any other relevant clinical details and any changes in clinical management recommendation will be recorded.
- Conditions
- Cardiovascular Diseases
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the impact of CaRi-Heart® analysis on clinical decision making after CCTA in a US setting.
The percentage of patients who received a change in recommended clinical management following review of their CaRi-Heart analysis.
Measured: Two weeks from initial review to review with CaRi-Heart results
Secondary outcomes (6)
To compare patient risk stratification with CaRi-Heart® analyses against standard clinical risk assessment tools (i.e., ASCVD-PCE).
The percentage of patients reclassified into a higher (or lower) risk category using the CaRi-Heart® based AI-Risk classification, when compared to standard clinical risk assessment tools (i.e., ASCVD-PCE).
Measured: Two weeks from initial review to review with CaRi-Heart results
Prevalence of high coronary inflammation (defined as FAI-Score in the 75th percentile) in the study population.
The percentage patients who have FAI-Score above the 75th percentile.
Measured: Two weeks from initial review to review with CaRi-Heart results
Prevalence of high coronary inflammation in participants with a 'normal' CCTA (i.e., CADRADS 0/1 or equivalent).
The percentage patients with a CADRADs score of 0-1, who have FAI-Score above the 75th percentile.
Measured: Two weeks from initial review to review with CaRi-Heart results
Sub-group analysis of prevalence of high coronary inflammation by clinical site and patient demographics.
The percentage patients who have FAI-Score above the 75th percentile in each of the following sub-groups: geographical location, patient age, patient sex, patient ancestry.
Measured: Two weeks from initial review to review with CaRi-Heart results
Correlation of FAI-Score with other available diagnostic test results (e.g., hsCRP, CACS etc.).
The correlation coefficient for FAI-Score versus other available diagnostic test results (e.g., hsCRP, CACS etc.).
Measured: Two weeks from initial review to review with CaRi-Heart results
Correlation of FAI-Score with quantitative plaque metrics (non-calcified plaque, calcified plaque, plaque burden)
The correlation coefficient for FAI-Score versus the quantitative plaque metrics.
Measured: Two weeks from initial review to review with CaRi-Heart results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caristo Diagnostics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arkansas Cardiology, P.A., Baptist Health, Louisville, Northeast Georgia Hospital System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986733
- Sponsor's protocol ID
- SMART-CCTA-1
- Acronym
- SMART-CCTA-1
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Management Alterations Resulting From CaRi-Heart® Technology in Patients Undergoing Coronary Computed Tomography Angiography (CCTA) for the Evaluation of Coronary Artery Disease: A United States Based Multi-Centre Study
- ClinicalTrials.gov ID
- NCT06986733
- Acronym / sponsor ID
- SMART-CCTA-1 / SMART-CCTA-1
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Caristo Diagnostics LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Arkansas Cardiology, P.A., Baptist Health, Louisville, Northeast Georgia Hospital System
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 May 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.
This study is an assessment of the impact of CaRi-Heart® on the clinical management of patients across at least three centres in the USA. This study is an observational study, in which clinicians will be presented with a patient's CCTA scan results and relevant clinical details (such as blood test results and clinical risk factors) with the resulting clinical management recommendation recorded; they will then be presented with the results of the CaRi-Heart® analysis alongside any other relevant clinical details and any changes in clinical management recommendation will be recorded.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any participant who has had a clinically indicated analysable CCTA at the three hospital collaborators
Key inclusion criteria (1 listed)
- Clinically indicated CCTA undertaken for evaluation of coronary artery disease.
Key exclusion criteria (3 listed)
- History of surgical revascularization (coronary artery bypass graft, CABG)
- CCTA undertaken for structural heart disease evaluation (e.g. transcatheter aortic valve replacement (TAVR)
- The CCTA is of poor quality or partly unanalyzable due to artifacts, such as motion-artifacts, breathing-artifacts, stack-artifacts or blooming-artifacts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the impact of CaRi-Heart® analysis on clinical decision making after CCTA in a US setting.
Time frame: Two weeks from initial review to review with CaRi-Heart results
The percentage of patients who received a change in recommended clinical management following review of their CaRi-Heart analysis.
6 secondary outcomes
To compare patient risk stratification with CaRi-Heart® analyses against standard clinical risk assessment tools (i.e., ASCVD-PCE).
Time frame: Two weeks from initial review to review with CaRi-Heart results
Prevalence of high coronary inflammation (defined as FAI-Score in the 75th percentile) in the study population.
Time frame: Two weeks from initial review to review with CaRi-Heart results
Prevalence of high coronary inflammation in participants with a 'normal' CCTA (i.e., CADRADS 0/1 or equivalent).
Time frame: Two weeks from initial review to review with CaRi-Heart results
Sub-group analysis of prevalence of high coronary inflammation by clinical site and patient demographics.
Time frame: Two weeks from initial review to review with CaRi-Heart results
Correlation of FAI-Score with other available diagnostic test results (e.g., hsCRP, CACS etc.).
Time frame: Two weeks from initial review to review with CaRi-Heart results
Correlation of FAI-Score with quantitative plaque metrics (non-calcified plaque, calcified plaque, plaque burden)
Time frame: Two weeks from initial review to review with CaRi-Heart results
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 23 May 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Caristo Diagnostics Limited.
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 23 May 2025. 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?
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?
To assess the impact of CaRi-Heart® analysis on clinical decision making after CCTA in a US setting. (time frame: Two weeks from initial review to review with CaRi-Heart results). 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 23 May 2025.