Coronary Artery DiseaseCARE-CCTANCT07220304
CaRi-Heart Assessment of Risk and Evaluation of Inflammation in Coronary CT Angiography (CARE-CCTA)
A study testing CaRi-Heart® Analysis in people with Coronary Artery Disease and Atherosclerosis, run by Corazon Medical PC at 18 sites in United States.
Trial summary
This study evaluates the use of CaRi-Heart® analysis, an artificial-intelligence (AI) software tool that measures inflammation in the coronary arteries using images already captured during a standard Coronary CT Angiography (CCTA) exam. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease, Atherosclerosis, Cardiovascular Inflammation
- What is being tested?
- CaRi-Heart® Analysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,000 participants
- Where
- 18 sitesUnited States
- Study dates
- Dec 2025to Jul 2028
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinically indicated CCTA undertaken for evaluation of coronary artery disease.
- Ability to provide written informed consent
- Patient between 18 and 80 years old
Who cannot join
- 1. History of surgical revascularization (coronary artery bypass graft, CABG) 2. CCTA undertaken for structural heart disease evaluation (e.g. transcatheter aortic valve replacement (TAVR) 3. The CCTA is of poor quality or partly unanalysable due to artifacts, such as motion-artifacts, breathing-artifacts, stack-artifacts or blooming-artifacts.
- 4. Inability to provide required health information 5. Pregnancy or any known contraindication for CCTA
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
United States18 sites
Corazon Imaging
Bay City, Michigan, 48124
HOUDA ABDALLAH, msn, 3136587778, habdallah@corazonimaging.com
JOSH KATKE, MHSA, JKATKE@CORAZONIMAGING.COM
Corazon Imaging
Berkley, Michigan, 48072
HOUDA ABDALLAH, msn, 3136587778, habdallah@corazonimaging.com
JOSH KATKE, MHSA, JKATKE@CORAZONIMAGING.COM
Corazon Imaging
Caro, Michigan, 48723
HOUDA ABDALLAH, msn, 3136587778, habdallah@corazonimaging.com
JOSH KATKE, MHSA, JKATKE@CORAZONIMAGING.COM
Corazon Imaging
Dearborn, Michigan, 48124
HOUDA ABDALLAH, msn, 3136587778, habdallah@corazonimaging.com
JOSH KATKE, MHSA, 2482298285, JKATKE@CORAZONIMAGING.COM
Corazon Imaging
Elizabethtown, Pennsylvania, 17022
HOUDA ABDALLAH, msn, 3136587778, habdallah@corazonimaging.com
JOSH KATKE, MHSA, JKATKE@CORAZONIMAGING.COM
Corazon Imaging
Flint, Michigan, 48532
HOUDA ABDALLAH, msn, 3136587778, habdallah@corazonimaging.com
JOSH KATKE, MHSA, JKATKE@CORAZONIMAGING.COM
Corazon Imaging
Grand Rapids, Michigan, 49546
HOUDA ABDALLAH, msn, 3136587778, habdallah@corazonimaging.com
HOUDA ABDALLAH, msn, habdallah@corazonimaging.com
Corazon Imaging
Lemoyne, Pennsylvania, 17043
HOUDA ABDALLAH, msn, 3136587778, habdallah@corazonimaging.com
HOUDA ABDALLAH, msn, habdallah@corazonimaging.com
Corazon Imaging
Livonia, Michigan, 48154
HOUDA ABDALLAH, msn, 3136587778, habdallah@corazonimaging.com
HOUDA ABDALLAH, msn, habdallah@corazonimaging.com
Corazon Imaging
Macomb, Michigan, 48044
HOUDA ABDALLAH, msn, 3136587778, habdallah@corazonimaging.com
HOUDA ABDALLAH, msn, habdallah@corazonimaging.com
Corazon Imaging
Madison Heights, Michigan, 48071
HOUDA ABDALLAH, msn, 3136587778, habdallah@corazonimaging.com
HOUDA ABDALLAH, msn, habdallah@corazonimaging.com
Corazon Imaging
Mount Pleasant, Michigan, 48858
HOUDA ABDALLAH, msn, 3136587778, habdallah@corazonimaging.com
HOUDA ABDALLAH, msn, habdallah@corazonimaging.com
Corazon Imaging
Novi, Michigan, 48377
HOUDA ABDALLAH, msn, 3136587778, habdallah@corazonimaging.com
HOUDA ABDALLAH, msn, habdallah@corazonimaging.com
Corazon Imaging
Saginaw, Michigan, 48603
HOUDA ABDALLAH, msn, 3136587778, habdallah@corazonimaging.com
HOUDA ABDALLAH, msn, habdallah@corazonimaging.com
Corazon Imaging
Saint Clair Shores, Michigan, 48080
HOUDA ABDALLAH, msn, 3136587778, habdallah@corazonimaging.com
HOUDA ABDALLAH, msn, habdallah@corazonimaging.com
Corazon Imaging
Sterling Heights, Michigan, 48310
HOUDA ABDALLAH, msn, 3136587778, habdallah@corazonimaging.com
HOUDA ABDALLAH, msn, habdallah@corazonimaging.com
Corazon Imaging
Trenton, Michigan, 48183
HOUDA ABDALLAH, msn, 3136587778, habdallah@corazonimaging.com
HOUDA ABDALLAH, msn, habdallah@corazonimaging.com
Corazon Imaging
Waterford, Michigan, 48327
HOUDA ABDALLAH, msn, 3136587778, habdallah@corazonimaging.com
HOUDA ABDALLAH, msn, habdallah@corazonimaging.com
About this study
Official title: CaRi-Heart® Assessment of Risk and Evaluation of Inflammation in Coronary CT Angiography (CARE-CCTA): A Prospective U.S. Community-Based Study on the Impact of CaRi-Heart® Analysis in Patients Undergoing CCTA for Coronary Artery Disease
This study evaluates the use of CaRi-Heart® analysis, an artificial-intelligence (AI) software tool that measures inflammation in the coronary arteries using images already captured during a standard Coronary CT Angiography (CCTA) exam. The goal is to determine whether the additional information provided by CaRi-Heart® changes clinical decision-making and helps improve early identification and management of coronary artery disease in community imaging centers. Patients who undergo CCTA as part of their regular care will be invited to have their scans analyzed using CaRi-Heart® at no extra cost, time, or radiation.
Read the detailed description
This is a prospective, community-based interventional study designed to assess the incremental value of CaRi-Heart® analysis in patients undergoing Coronary CT Angiography (CCTA) for evaluation of suspected or known coronary artery disease.
CaRi-Heart® is a software-as-a-medical-device (SaMD) that uses advanced AI algorithms to quantify coronary inflammation and generate a CaRi-Heart® Risk Score from existing CCTA images. The analysis provides color-coded visualization and quantitative metrics that may improve risk stratification beyond traditional plaque and stenosis assessment.
The study aims to compare management decisions made before and after review of the CaRi-Heart® analysis, measuring how often the additional information influences diagnostic interpretation or changes treatment recommendations (such as preventive therapy or referral).
Approximately 15,000 participants will be enrolled across multiple outpatient imaging centers in Michigan. All data will be collected under standard clinical workflows with IRB approval, informed consent, and HIPAA compliance. No additional scanning, contrast, or radiation exposure will occur.
- Being tested
- CaRi-Heart® Analysis
- Keywords
- CaRi-Heart, Coronary CT Angiography (CCTA), AI Cardiac Imaging, Coronary Inflammation, Cardiovascular Risk Stratification, Plaque Characterization, Community-Based Imaging, Noninvasive Cardiac Diagnostics, Artificial Intelligence in Cardiology
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaRi-Heart® AnalysisDevice
Also called AI-based coronary inflammation analysis, CaRi-Heart Risk Score
CaRi-Heart® is an artificial-intelligence-based software device that analyzes coronary CT angiography (CCTA) images to quantify coronary inflammation and generate a CaRi-Heart Risk Score. The analysis provides color-coded visualization and quantitative metrics derived from perivascular fat tissue characteristics, enabling improved assessment of coronary artery disease risk.
In this study, CaRi-Heart® analysis is applied prospectively to CCTA images obtained as part of standard clinical care. The results are reviewed by the interpreting physician and recorded to determine whether the additional information affects diagnostic interpretation or management decisions. No additional imaging, radiation, or contrast exposure occurs.
| Study group | Role | What they receive |
|---|---|---|
| CaRi-Heart® Analysis Group | Experimental | Participants receiving standard CCTA with CaRi-Heart® software analysis to assess coronary inflammation and evaluate impact on clinical decision-making. Receives: Device: CaRi-Heart® Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinical management decisions following CaRi-Heart® analysis
The proportion of patients for whom the addition of CaRi-Heart® analysis to standard Coronary CT Angiography (CCTA) results in a change in clinical management decisions, such as initiation or adjustment of preventive therapies (e.g., statins, antiplatelet agents, lifestyle modification, or cardiology referral).
Management decisions before and after reviewing CaRi-Heart® results will be compared to quantify impact on diagnostic interpretation and treatment planning
Measured: Up to 60 days following CCTA completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2025
- Study startDec 2025 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm prospective diagnostic study evaluating the incremental value of CaRi-Heart® analysis in patients undergoing Coronary CT Angiography (CCTA) for suspected or known coronary artery disease
- Masking
- None (open label)
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corazon Medical PC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220304
- Sponsor's protocol ID
- CARE-CCTA-001
- Acronym
- CARE-CCTA
- Status last verified
- Oct 2025
- First submitted
- 22 Oct 2025
- Last updated
- 23 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: De-identified individual participant data (IPD) may be shared with qualified researchers upon reasonable request after study completion, subject to IRB approval, institutional policies, and a data-use agreement. Data elements may include demographic variables, CaRi-Heart® risk scores, and CCTA-derived imaging metrics. No protected health information (PHI) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CaRi-Heart® Assessment of Risk and Evaluation of Inflammation in Coronary CT Angiography (CARE-CCTA): A Prospective U.S. Community-Based Study on the Impact of CaRi-Heart® Analysis in Patients Undergoing CCTA for Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT07220304
- Acronym / sponsor ID
- CARE-CCTA / CARE-CCTA-001
- Keywords
- CaRi-Heart, Coronary CT Angiography (CCTA), AI Cardiac Imaging, Coronary Inflammation, Cardiovascular Risk Stratification, Plaque Characterization, Community-Based Imaging, Noninvasive Cardiac Diagnostics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Corazon Medical PCUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 23 Oct 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 evaluates the use of CaRi-Heart® analysis, an artificial-intelligence (AI) software tool that measures inflammation in the coronary arteries using images already captured during a standard Coronary CT Angiography (CCTA) exam. The goal is to determine whether the additional information provided by CaRi-Heart® changes clinical decision-making and helps improve early identification and management of coronary artery disease in community imaging centers. Patients who undergo CCTA as part of their regular care will be invited to have their scans analyzed using CaRi-Heart® at no extra cost, time, or radiation.
Detailed description
This is a prospective, community-based interventional study designed to assess the incremental value of CaRi-Heart® analysis in patients undergoing Coronary CT Angiography (CCTA) for evaluation of suspected or known coronary artery disease.
CaRi-Heart® is a software-as-a-medical-device (SaMD) that uses advanced AI algorithms to quantify coronary inflammation and generate a CaRi-Heart® Risk Score from existing CCTA images. The analysis provides color-coded visualization and quantitative metrics that may improve risk stratification beyond traditional plaque and stenosis assessment.
The study aims to compare management decisions made before and after review of the CaRi-Heart® analysis, measuring how often the additional information influences diagnostic interpretation or changes treatment recommendations (such as preventive therapy or referral).
Approximately 15,000 participants will be enrolled across multiple outpatient imaging centers in Michigan. All data will be collected under standard clinical workflows with IRB approval, informed consent, and HIPAA compliance. No additional scanning, contrast, or radiation exposure will occur.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm prospective diagnostic study evaluating the incremental value of CaRi-Heart® analysis in patients undergoing Coronary CT Angiography (CCTA) for suspected or known coronary artery disease
| Arm | Type | Receives |
|---|---|---|
| CaRi-Heart® Analysis Group | Experimental | Device: CaRi-Heart® AnalysisParticipants receiving standard CCTA with CaRi-Heart® software analysis to assess coronary inflammation and evaluate impact on clinical decision-making. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clinically indicated CCTA undertaken for evaluation of coronary artery disease.
- Ability to provide written informed consent
- Patient between 18 and 80 years old
Key exclusion criteria (2 listed)
- 1. History of surgical revascularization (coronary artery bypass graft, CABG) 2. CCTA undertaken for structural heart disease evaluation (e.g. transcatheter aortic valve replacement (TAVR) 3. The CCTA is of poor quality or partly unanalysable due to artifacts, such as motion-artifacts, breathing-artifacts, stack-artifacts or blooming-artifacts.
- 4. Inability to provide required health information 5. Pregnancy or any known contraindication for CCTA
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 |
|---|---|---|
| CaRi-Heart® AnalysisAlso: AI-based coronary inflammation analysis, CaRi-Heart Risk ScoreCaRi-Heart® is an artificial-intelligence-based software device that analyzes coronary CT angiography (CCTA) images to quantify coronary inflammation and generate a CaRi-Heart Risk Score. The analysis provides color-coded visualization and quantitative metrics derived from perivascular fat tissue characteristics, enabling improved assessment of coronary artery disease risk. In this study, CaRi-Heart® analysis is applied prospectively to CCTA images obtained as part of standard clinical care. The results are reviewed by the interpreting physician and recorded to determine whether the additional information affects diagnostic interpretation or management decisions. No additional imaging, radiation, or contrast exposure occurs. | Device | CaRi-Heart® Analysis Group |
Primary outcome
Change in clinical management decisions following CaRi-Heart® analysis
Time frame: Up to 60 days following CCTA completion
The proportion of patients for whom the addition of CaRi-Heart® analysis to standard Coronary CT Angiography (CCTA) results in a change in clinical management decisions, such as initiation or adjustment of preventive therapies (e.g., statins, antiplatelet agents, lifestyle modification, or cardiology referral). Management decisions before and after reviewing CaRi-Heart® results will be compared to quantify impact on diagnostic interpretation and treatment planning
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 Oct 2025.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data (IPD) may be shared with qualified researchers upon reasonable request after study completion, subject to IRB approval, institutional policies, and a data-use agreement. Data elements may include demographic variables, CaRi-Heart® risk scores, and CCTA-derived imaging metrics. No protected health information (PHI) will be shared.
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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.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CaRi-Heart® Analysis in people with Coronary Artery Disease and Atherosclerosis, run by Corazon Medical PC at 18 sites in United States.
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 2 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 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. 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 HOUDA ABDALLAH, msn (3136587778, habdallah@corazonimaging.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinical management decisions following CaRi-Heart® analysis (time frame: Up to 60 days following CCTA completion). 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 Oct 2025.