Acute Coronary SyndromesNCT06089343
High-risk Features of Coronary Lesions in CTA and OCT
An observational study of Acute Coronary Syndromes, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This study is a multicenter and retrospective study. ACS patients who underwent CCTA or OCT from 1 months to 3 years prior to the event will be retrospectively identified. Plaques in the non-culprit vessels will be regarded as a primary control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndromes
- What is being tested?
- Coronary CT angiography
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to Oct 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who presented with acute coronary syndrome (acute myocardial infarction or unstable angina) and had undergone CCTA from 1 months to 3 years prior to the event.
Who may be able to join
- Patients who presented with ACS and underwent invasive coronary angiography or OCT
- The patients who underwent coronary CT angiography, regardless of the reason (for example, routine healthcare check-up, or evaluation for stable angina or atypical chest pain) prior to the acute event.
- Time limit of CCTA: 1 months ~ 3 years prior to the event.
Who cannot join
- Patients with stents in two or more vessel territories prior to CCTA Poor quality of CCTA which is unsuitable for plaque and CFD analysis Patients with ACS culprit lesion in a stented segment Patients with previous history of coronary artery bypass graft surgery Patients with revascularization after CCTA and before ACS event Secondary ACS due to other general medical conditions, such as sepsis, arrhythmia, bleeding, etc.
- --Additional exclusion criteria for Computational Fluid Dynamics Poor quality CCTA images unsuitable for CFD and plaque analysis No unprocessed CCTA data
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200030
About this study
Official title: Exploring the High-risk Features of Coronary Lesions Using CT Angiography and Optical Coherence Tomography
This study is a multicenter and retrospective study. ACS patients who underwent CCTA or OCT from 1 months to 3 years prior to the event will be retrospectively identified. Plaques in the non-culprit vessels will be regarded as a primary control group.
Read the detailed description
The high-risk features of plaque rupture and subsequent acute coronary syndrome (ACS) are not fully identified. Plaque features, hemodynamic forces, and the interaction between these factors may cause plaque instability and subsequent clinical events. A previous study showed that the addition of hemodynamic parameters calculated noninvasively from coronary computed tomography (CCTA) using computational fluid dynamics (such as wall shear stress and axial plaque stress) improved the ability to predict the risk of ACS compared with conventional approaches based on anatomical stenosis severity and adverse plaque characteristics. Wall shear stress and axial plaque stress derived from CT were highly correlated to those derived from optical coherence tomography (OCT). In addition, other hemodynamic parameters, such as oscillatory shear index, endothelial shear stress (ESS), and spatial ESS gradient have also been demonstrated to be associated with unstable plaque. In this regard, we designed this study to find the best hemodynamic and plaque features derived from CTA and verified by OCT to predict ACS, and to investigate whether a comprehensive risk prediction model with them has an incremental value in a larger population.
- Conditions
- Acute Coronary Syndromes
- Being tested
- Coronary CT angiography
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary CT angiographyDiagnostic test
Comprehensive hemodynamic and plaque features derived from CTA and verified by OCT of all culprit and non-culprit lesions to predict ACS.
| Study group | Role | What they receive |
|---|---|---|
| Culprit | Plaques which is related with acute coronary syndrome Receives: Diagnostic Test: Coronary CT angiography | |
| Non-culprit | Plaques which is not related with acute coronary syndrome Receives: Diagnostic Test: Coronary CT angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
discrimination index of prediction model
Measured: 1 months - 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Oct 2023
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089343
- Sponsor's protocol ID
- ACS-CTA&OCT
- Status last verified
- Oct 2023
- First submitted
- 13 Oct 2023
- Last updated
- 18 Oct 2023
- 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 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the High-risk Features of Coronary Lesions Using CT Angiography and Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT06089343
- Acronym / sponsor ID
- ACS-CTA&OCT
- Conditions
- Acute Coronary Syndromes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 18 Oct 2023 (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 a multicenter and retrospective study. ACS patients who underwent CCTA or OCT from 1 months to 3 years prior to the event will be retrospectively identified. Plaques in the non-culprit vessels will be regarded as a primary control group.
Detailed description
The high-risk features of plaque rupture and subsequent acute coronary syndrome (ACS) are not fully identified. Plaque features, hemodynamic forces, and the interaction between these factors may cause plaque instability and subsequent clinical events. A previous study showed that the addition of hemodynamic parameters calculated noninvasively from coronary computed tomography (CCTA) using computational fluid dynamics (such as wall shear stress and axial plaque stress) improved the ability to predict the risk of ACS compared with conventional approaches based on anatomical stenosis severity and adverse plaque characteristics. Wall shear stress and axial plaque stress derived from CT were highly correlated to those derived from optical coherence tomography (OCT). In addition, other hemodynamic parameters, such as oscillatory shear index, endothelial shear stress (ESS), and spatial ESS gradient have also been demonstrated to be associated with unstable plaque. In this regard, we designed this study to find the best hemodynamic and plaque features derived from CTA and verified by OCT to predict ACS, and to investigate whether a comprehensive risk prediction model with them has an incremental value in a larger population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culprit | – | Diagnostic Test: Coronary CT angiographyPlaques which is related with acute coronary syndrome |
| Non-culprit | – | Diagnostic Test: Coronary CT angiographyPlaques which is not related with acute coronary syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who presented with acute coronary syndrome (acute myocardial infarction or unstable angina) and had undergone CCTA from 1 months to 3 years prior to the event.
Key inclusion criteria (3 listed)
- Patients who presented with ACS and underwent invasive coronary angiography or OCT
- The patients who underwent coronary CT angiography, regardless of the reason (for example, routine healthcare check-up, or evaluation for stable angina or atypical chest pain) prior to the acute event.
- Time limit of CCTA: 1 months ~ 3 years prior to the event.
Key exclusion criteria (2 listed)
- Patients with stents in two or more vessel territories prior to CCTA Poor quality of CCTA which is unsuitable for plaque and CFD analysis Patients with ACS culprit lesion in a stented segment Patients with previous history of coronary artery bypass graft surgery Patients with revascularization after CCTA and before ACS event Secondary ACS due to other general medical conditions, such as sepsis, arrhythmia, bleeding, etc.
- --Additional exclusion criteria for Computational Fluid Dynamics Poor quality CCTA images unsuitable for CFD and plaque analysis No unprocessed CCTA data
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 |
|---|---|---|
| Coronary CT angiographyComprehensive hemodynamic and plaque features derived from CTA and verified by OCT of all culprit and non-culprit lesions to predict ACS. | Diagnostic test | Culprit, Non-culprit |
Primary outcome
discrimination index of prediction model
Time frame: 1 months - 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
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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?
An observational study of Acute Coronary Syndromes, run by Shanghai Zhongshan Hospital at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 18 Oct 2023. 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 China. 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?
Results are not available in the source record.
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?
discrimination index of prediction model (time frame: 1 months - 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 18 Oct 2023.