Chronic Coronary SyndromeFOCUS DLNCT06186336
Feasibility of a Deep Learning-based Algorithm for Non-invasive Assessment of Vulnerable Coronary Plaque
An observational study of Chronic Coronary Syndrome and Coronary Artery Disease, run by GE Healthcare at 1 site in Italy.
Trial summary
The primary objective of this study is to assess the accuracy in terms of sensitivity, specificity, negative and positive predicted values of the DL-based algorithm with respect to correct identification of the plaque and associated vulnerability grade. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Coronary Syndrome, Coronary Artery Disease, Stable Angina
- What is being tested?
- Deep Learning-based Vulnerable Plaque Detection and Assessment Tool
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2025to Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with chronic coronary syndrome or stable angina, as well as patients with signs of acute coronary syndrome who have been ordered a clinically indicated CCTA and will likely be referred to undergo an ICA combined with OCT will be enrolled in this study. Subjects with recent onset or growing angina may be included in the study. Subjects will be representative of the general population expected to undergo cardiac non-invasive and invasive imaging and treatment procedures as standard of care clinical practice. The CCTA and ICA with OCT must be carried out within 10 days one from each other. Clinical decision for a PCI after the diagnostic procedures will not limit the enrollment. To preserve the aspect of the plaque, CCTA must be performed first.
Who may be able to join
- Patients referred for a clinically indicated CCTA and ICA with OCT imaging examinations;
- Diagnosis of chronic coronary syndrome, known CAD, or stable angina; AND,
- Patients with ACS that may undergo a CCTA and not refer directly to the Cath lab for revascularization procedures.
Who cannot join
- Contradictions to contrast;
- Contraindications for beta blocker;
- BMI >30;
- High heart rate ≥75 BPM;
- Atrial Fibrillation;
- Arrythmia or irregular heartbeats;
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- Any prior coronary revascularization;
- Presence of pacemaker or implantable cardioverter defibrillator; OR,
- Patients with TAVI/TAVR.
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
Ospedale Di Voghera, Azienda Socio-Sanitaria Territoriale di Pavia
Pavia, Lombardy, 27100
Pietro Broglia, MD, +39 0383 695682, pietro_broglia@asst-pavia.it
Pietro Broglia, MD
About this study
The primary objective of this study is to assess the accuracy in terms of sensitivity, specificity, negative and positive predicted values of the DL-based algorithm with respect to correct identification of the plaque and associated vulnerability grade.
Read the detailed description
Data collected in this study will be used for technology development, scientific evaluation, education, and regulatory submissions for future products. This is a pre-market, open label, prospective, non-randomized clinical research study conducted at one site in Italy. The product being researched is the Deep Learning-based (DL) algorithm for non-invasive detection of vulnerable coronary plaque.
- Conditions
- Chronic Coronary Syndrome, Coronary Artery Disease, Stable Angina, Acute Coronary Syndrome
- Being tested
- Deep Learning-based Vulnerable Plaque Detection and Assessment Tool
- Keywords
- Coronary CT Angiography, Invasive Coronary Angiography, Optical Coherence Tomography, Vulnerable Coronary Plaque
- Medical subject headings
- Coronary Artery Disease, Angina, Stable, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Learning-based Vulnerable Plaque Detection and Assessment ToolOther
Scanning requirements for the clinically indicated CCTA and ICA with OCT will be performed according to current site(s) guidelines and procedures. Administration of medications (such as contrast agents and potentially beta-blockers and other medications) will be given according to standard hospital care.
This is a prospective research study evaluating an investigational product. The tool's use is intended for research purposes and is not intended as a substitute for required medical care. The CCTA and ICA with OCT will be processed in real-time using the site's locally available post-processing tools in order to guide the subject's medical care. Once the ICA with OCT is complete, the de-identified CCTA data will be inputted in the investigational tool.
The clinically indicated CCTA and the ICA with OCT will both take approximately 1 hour and will take place within 10 days. No additional imaging is needed as part of the study.
| Study group | Role | What they receive |
|---|---|---|
| DL-Based Vulnerable Plaque Detection and Assessment Tool | Enrolled subjects will receive a clinically indicated CCTA and ICA with OCT within 10 days. At least two qualified CCTA radiologists will independently review and annotate the coronary plaques in the CCTA using their local post-processing tools. At least two trained OCT readers will review and annotate the coronary plaques in the ICA/OCT using their local post-processing tools.
The original de-identified CCTA data will be inputted into the Vulnerable Plaque Detection and Assessment Tool. The tool will perform the automatic identification of the plaque location and characteristics. These results will be compared to assess the algorithm's performance. Receives: Other: Deep Learning-based Vulnerable Plaque Detection and Assessment Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data Collection
Number of subjects with raw CCTA and ICA with OCT data
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Accuracy of Tool
Sensitivity, specificity, negative, and positive predicted values of the DL-based algorithm with respect to correct identification of the plaque and associated vulnerability grade in comparison to qualified readers
Measured: Through study completion, an average of 1 year
Safety Events
Number of AEs, SAEs, and product issues
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study startJan 2025 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Azienda Socio-Sanitaria Territoriale di Pavia
- Responsible party
- Sponsor
- Investigators
- Paul Deak, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186336
- Sponsor's protocol ID
- 12019187648
- Acronym
- FOCUS DL
- Status last verified
- Nov 2024
- First submitted
- 15 Dec 2023
- Last updated
- 7 Jan 2025
- 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 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Deep Learning-based Algorithm for Non-invasive Assessment of Vulnerable Coronary Plaque
- ClinicalTrials.gov ID
- NCT06186336
- Acronym / sponsor ID
- FOCUS DL / 12019187648
- Conditions
- Chronic Coronary Syndrome, Coronary Artery Disease, Stable Angina, Acute Coronary Syndrome
- Keywords
- Coronary CT Angiography, Invasive Coronary Angiography, Optical Coherence Tomography, Vulnerable Coronary Plaque
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Azienda Socio-Sanitaria Territoriale di Pavia
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 2 Jan 2024 (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.
The primary objective of this study is to assess the accuracy in terms of sensitivity, specificity, negative and positive predicted values of the DL-based algorithm with respect to correct identification of the plaque and associated vulnerability grade.
Detailed description
Data collected in this study will be used for technology development, scientific evaluation, education, and regulatory submissions for future products. This is a pre-market, open label, prospective, non-randomized clinical research study conducted at one site in Italy. The product being researched is the Deep Learning-based (DL) algorithm for non-invasive detection of vulnerable coronary plaque.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DL-Based Vulnerable Plaque Detection and Assessment Tool | – | Other: Deep Learning-based Vulnerable Plaque Detection and Assessment ToolEnrolled subjects will receive a clinically indicated CCTA and ICA with OCT within 10 days. At least two qualified CCTA radiologists will independently review and annotate the coronary plaques in the CCTA using their local post-processing tools. At least two trained OCT readers will review and annotate the coronary plaques in the ICA/OCT using their local post-processing tools. The original de-identified CCTA data will be inputted into the Vulnerable Plaque Detection and Assessment Tool. The tool will perform the automatic identification of the plaque location and characteristics. These results will be compared to assess the algorithm's performance. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with chronic coronary syndrome or stable angina, as well as patients with signs of acute coronary syndrome who have been ordered a clinically indicated CCTA and will likely be referred to undergo an ICA combined with OCT will be enrolled in this study. Subjects with recent onset or growing angina may be included in the study. Subjects will be representative of the general population expected to undergo cardiac non-invasive and invasive imaging and treatment procedures as standard of care clinical practice. The CCTA and ICA with OCT must be carried out within 10 days one from each other. Clinical decision for a PCI after the diagnostic procedures will not limit the enrollment. To preserve the aspect of the plaque, CCTA must be performed first.
Key inclusion criteria (3 listed)
- Patients referred for a clinically indicated CCTA and ICA with OCT imaging examinations;
- Diagnosis of chronic coronary syndrome, known CAD, or stable angina; AND,
- Patients with ACS that may undergo a CCTA and not refer directly to the Cath lab for revascularization procedures.
Key exclusion criteria (9 listed)
- Contradictions to contrast;
- Contraindications for beta blocker;
- BMI >30;
- High heart rate ≥75 BPM;
- Atrial Fibrillation;
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 |
|---|---|---|
| Deep Learning-based Vulnerable Plaque Detection and Assessment ToolScanning requirements for the clinically indicated CCTA and ICA with OCT will be performed according to current site(s) guidelines and procedures. Administration of medications (such as contrast agents and potentially beta-blockers and other medications) will be given according to standard hospital care. This is a prospective research study evaluating an investigational product. The tool's use is intended for research purposes and is not intended as a substitute for required medical care. The CCTA and ICA with OCT will be processed in real-time using the site's locally available post-processing tools in order to guide the subject's medical care. Once the ICA with OCT is complete, the de-identified CCTA data will be inputted in the investigational tool. The clinically indicated CCTA and the ICA with OCT will both take approximately 1 hour and will take place within 10 days. No additional imaging is needed as part of the study. | Other | DL-Based Vulnerable Plaque Detection and Assessment Tool |
Primary outcome
Data Collection
Time frame: Through study completion, an average of 1 year
Number of subjects with raw CCTA and ICA with OCT data
2 secondary outcomes
Accuracy of Tool
Time frame: Through study completion, an average of 1 year
Safety Events
Time frame: Through study completion, an average of 1 year
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 7 Jan 2025.
- 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.
Paul Deak study director
GE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Coronary Syndrome and Coronary Artery Disease, run by GE Healthcare 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 9 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 7 Jan 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?
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 Melissa Challman (8582213007, melissa.challman@gehealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data Collection (time frame: Through study completion, an average of 1 year). 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 7 Jan 2025.