Coronary Artery DiseaseCHART-VISIONNCT05380622
CHART Study of Coronary CT Angiography in Coronary Artery Disease
An observational study of Coronary Artery Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
In a cohort of patients referred to coronary computed tomography angiography (CCTA), the investigators aim: 1. To describe the natural history of the coronary atherosclerotic plaque development and progression or regression, as well as the plaque characterization and phenotypes over time by CCTA among deferred… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Coronary CT angiography
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 31 Dec 2030
- 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: Patients with an indication for CCTA.
Who may be able to join
- Patients with an indication for CCTA.
- Qualified patients who have signed a written informed consent form.
Who cannot join
- Left ventricular ejection fraction < 35%
- Acute ST-elevation myocardial infarction within 72 hours or previous coronary artery bypass graft surgery
- Abnormal epicardial coronary flow (TIMI flow < 3)
- Planned coronary artery bypass graft surgery after diagnostic angiography
- Poor quality of CCTA or other reasons by core lab that are unsuitable for plaque, physiological or fat analysis
- Patients with a stent in the target vessel
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Zhongshan Hospital
Shanghai
Neng Dai, MD, +8613701997266, niceday1987@hotmail.com
Junbo Ge, MD
About this study
Official title: CHART Study of Coronary CT Angiography to Predict Imaging and Cardiovascular Outcomes in Patients With Coronary Artery Disease
In a cohort of patients referred to coronary computed tomography angiography (CCTA), the investigators aim:
- To describe the natural history of the coronary atherosclerotic plaque development and progression or regression, as well as the plaque characterization and phenotypes over time by CCTA among deferred coronary lesions
- To explore the precursors of plaques leading to acute coronary syndrome (ACS) or chronic coronary syndrome (CCS) in deferred coronary lesions
- To investigate prognostic implication of qualitative and quantitative plaque analysis of stenosis and plaque features, disease patterns, hemodynamic parameters, and fat metrics on CCTA along with physiologic assessment
- To investigate the effects of different treatment strategies according to stenosis and plaque features, fat metrics on CCTA along with physiologic assessments.
Read the detailed description
Invasive physiologic indices such as fractional flow reserve (FFR) are used to define ischemia-causing stenosis and guide percutaneous coronary intervention (PCI) in the clinical practice. FFR-guided PCI has been proven to improve clinical outcomes, however, a substantial proportion of patients continue to experience clinical events. The ISCHEMIA trial showed that invasive therapy did not improve prognosis in patients with moderate to severe ischemia compared to optimal medical therapy. Besides, a recent study implied that even in vessels with FFR>0.80, those have lesions with high-risk plaque characteristics (HRPC) demonstrated worse clinical outcomes. This might be not unexpected since previous evidence from postmortem studies demonstrated that unstable atherosclerotic plaques are prone to rupture and trigger adverse cardiovascular events.
In recent years, advances in imaging analysis made it possible to conduct novel measurements such as pericoronary inflammation or epicardial fat metrics and lesion-specific or vessel-specific hemodynamic parameters derived from CCTA (such as fractional flow reserve by CCTA [CT-FFR]) as well as the coronary disease patterns defined by physiologic distribution (predominant focal versus diffuse disease defined by CCTA derived pullback pressure gradient index) and local severity (presence versus absence of major gradient defined by CCTA-derived FFR gradient per unit length [dCT-FFR/ds]) of coronary atherosclerosis.
However, the relationship of these parameters and the combination of these indices on clinical outcomes has not been fully understood. Furthermore, though it has been known that high-risk plaques are related with worse outcomes even no significant blood flow impairment induced, best treatment strategy for these lesions remains unclear.
In this regard, the aims of this study are multiple, all the treatment strategies are at the discretion of the physicians in charge. For patients without further invasive angiography performed after CCTA or deferred for revascularization after invasive angiography with/without physiology or imaging assessments, the investigators will investigate coronary atherosclerotic plaque development and progression or regression, as well as the plaque characterization and phenotypes over time by CCTA, and to explore the precursors of plaques leading to acute coronary syndrome (ACS) or chronic coronary syndrome (CCS); for those with received revascularization, the investigators will investigate the prognostic value of CCTA based comprehensive analysis of coronary in combination with physiologic assessment. In all patients, the effects of different treatment strategies according to stenosis and plaque features, fat metrics as well as physiologic assessments will be investigated.
CHART is a study group called Chinese Non-invasive Cardiovascular Imaging and Physiology Study Group, the current study will be conducted by CHART and by invitation in multiple Chinese centers.
- Conditions
- Coronary Artery Disease
- Being tested
- Coronary CT angiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary CT angiographyDiagnostic test
Coronary CT angiography (CCTA) will be performed according to standard protocol and measurement of fractional flow reserve (FFR) or other physiological indices will be at the at the discretion of the physicians in charge.
Stenosis and plaque features, disease patterns, hemodynamic parameters, and fat metrics on CCTA will be analyzed blindly in the core lab.
| Study group | Role | What they receive |
|---|---|---|
| Without ICA or deferral of PCI after ICA group | Patients didn't undergo invasive coronary angiography (ICA) or with a vessel determined to defer revascularization. Receives: Diagnostic Test: Coronary CT angiography | |
| PCI group | Patients with a vessel that undergo percutaneous coronary intervention (PCI) Receives: Diagnostic Test: Coronary CT angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of occurrence of high-risk plaques
Frequency (%) of occurrence of high-risk plaque morphologic features (Housfield Unit[HU]<30, Remodelling Index > 1.1, napkin-ring sign, spotty calcium, minimal lumen area[MLA]<4mm2 \& plaque burden[PB]≥70%), physiologic diffuse disease, inflammation by high fat attenuation index (FAI)
Measured: 30 days
Change in total plaque volume (adjusted by vessel volume) and plaque composition detected by follow up CCTA
Change in total plaque volume (adjusted by vessel volume) and plaque composition detected by follow up CCTA
Measured: up to 5 years after index procedure
Change in WSS detected by follow up CCTA
Change in hemodynamic parameter of wall shear stress (WSS) detected by follow up CCTA
Measured: up to 5 years after index procedure
Change in APS detected by follow up CCTA
Change in hemodynamic parameter of axial plaque stress (APS) detected by follow up CCTA
Measured: up to 5 years after index procedure
Change in SSI detected by follow up CCTA
Change in stenosis susceptibility index (SSI) detected by follow up CCTA
Measured: up to 5 years after index procedure
Change in hemodynamic parameters delta fractional flow reserve detected by follow up CCTA
Change in hemodynamic parameters delta fractional flow reserve detected by follow up CCTA
Measured: up to 5 years after index procedure
Change in physiological pattern by PPG derived by follow up CCTA
Change in physiological pattern by pullback pressure gradient (PPG) derived by follow up CCTA
Measured: up to 5 years after index procedure
Change in dCT-FFR/ds detected by follow up CCTA
Change in dCT-FFR/ds detected by follow up CCTA
Measured: up to 5 years after index procedure
Change in CT-FFR
Change in fractional flow reserve by CCTA
Measured: up to 5 years after index procedure
Change in peri-coronary adipose tissue assessed by follow up CCTA
Change in peri-coronary adipose tissue assessed by follow up CCTA
Measured: up to 5 years after index procedure
CCTA-derived features associated with precursors of ACS or CCS
CCTA-derived features associated with precursors of ACS or CCS
Measured: up to 5 years after index procedure
Adverse cardiovascular event according to stenosis and plaque features, disease patterns, hemodynamic parameters, and fat metrics on CCTA along with physiologic assessment
A composite of cardiac death, vessel-related myocardial infarction (MI), or vessel-related ischemia-driven revascularization.
Measured: up to 5 years after index procedure
Adverse cardiovascular event according to different treatment strategies according to stenosis and plaque features, fat metrics on CCTA along with physiologic assessments.
A composite of cardiac death, vessel-related myocardial infarction (MI), or vessel-related ischemia-driven revascularization.
Measured: up to 5 years after index procedure
Secondary outcomes (14)
Anginal status
Change in Health Related Quality of Life (HRQL)
Measured: up to 5 years after index procedure
Number of anti-anginal medication prescribed
Number of anti-anginal medication prescribed
Measured: up to 5 years after index procedure
Clinical predictors of events
To find out the models with baseline characteristics including age, sex, cardiovascular risk factors and so on with the highest area under curve to predict a composite of cardiac death, vessel-related myocardial infarction (MI), or vessel-related ischemia-driven revascularization.
Measured: up to 5 years after index procedure
Prognostic value of CCTA defined anatomy and plaque characterization
Prognostic value of CCTA defined anatomy including diameter stenosis, area stenosis and plaque characterization including plaque components, physiological on blood flow, diffuseness and inflammation.
Measured: up to 5 years after index procedure
Prognostic value of WSS
Prognostic value of WSS
Measured: up to 5 years after index procedure
Prognostic value of APS
Prognostic value of APS
Measured: up to 5 years after index procedure
Prognostic value of SSI
Prognostic value of SSI
Measured: up to 5 years after index procedure
Prognostic value of delta CT-FFR
Prognostic value of delta CT-FFR
Measured: up to 5 years after index procedure
Prognostic value of pull pressure gradient
Prognostic value of pull pressure gradient
Measured: up to 5 years after index procedure
Prognostic value of dCT-FFR/ds
Prognostic value of dCT-FFR/ds
Measured: up to 5 years after index procedure
Prognostic value of per-coronary adipose tissue
Prognostic value of per-coronary adipose tissue derived fat attenuation index and other radiomics features.
Measured: up to 5 years after index procedure
Prognostic value of integrated CCTA based lesion anatomy, plaque characterization, hemodynamic parameters, physiological patterns and per-coronary adipose tissue for ACS
Comparison of outcome discrimination ability.
Measured: up to 5 years after index procedure
Prognostic value of integrated CCTA based lesion anatomy, plaque characterization, hemodynamic parameters, physiological patterns and per-coronary adipose tissue for cardiovascular events
Comparison of outcome discrimination ability.
Measured: up to 5 years after index procedure
Relationship among CT-derived plaque qualification and quantification, and CT-defined pericoronary and epicardial fat metrics with physiological assessments.
Association among CCTA parameters (including diameter stenosis, area stenosis, plaque components) and physiologic indices (CT-FFR, PPG, delta-FFR, dCT-FFR/ds).
Measured: up to 5 years after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Jan 2015
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junbo Ge, Professor, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380622
- Sponsor's protocol ID
- CHART-20220510
- Acronym
- CHART-VISION
- Status last verified
- May 2022
- First submitted
- 10 May 2022
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dai N, Tang X, Hu Y, Lu H, Chen Z, Duan S, Guo W, Edavi PP, Yu Y, Huang D, Qian J, Ge J. SARS-CoV-2 Infection Association with Atherosclerotic Plaque Progression at Coronary CT Angiography and Adverse Cardiovascular Events. Radiology. 2025 Feb;314(2):e240876. doi: 10.1148/radiol.240876.
PubMed 39903078
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHART Study of Coronary CT Angiography to Predict Imaging and Cardiovascular Outcomes in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT05380622
- Acronym / sponsor ID
- CHART-VISION / CHART-20220510
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 19 May 2022 (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.
In a cohort of patients referred to coronary computed tomography angiography (CCTA), the investigators aim:
- To describe the natural history of the coronary atherosclerotic plaque development and progression or regression, as well as the plaque characterization and phenotypes over time by CCTA among deferred coronary lesions
- To explore the precursors of plaques leading to acute coronary syndrome (ACS) or chronic coronary syndrome (CCS) in deferred coronary lesions
- To investigate prognostic implication of qualitative and quantitative plaque analysis of stenosis and plaque features, disease patterns, hemodynamic parameters, and fat metrics on CCTA along with physiologic assessment
- To investigate the effects of different treatment strategies according to stenosis and plaque features, fat metrics on CCTA along with physiologic assessments.
Detailed description
Invasive physiologic indices such as fractional flow reserve (FFR) are used to define ischemia-causing stenosis and guide percutaneous coronary intervention (PCI) in the clinical practice. FFR-guided PCI has been proven to improve clinical outcomes, however, a substantial proportion of patients continue to experience clinical events. The ISCHEMIA trial showed that invasive therapy did not improve prognosis in patients with moderate to severe ischemia compared to optimal medical therapy. Besides, a recent study implied that even in vessels with FFR>0.80, those have lesions with high-risk plaque characteristics (HRPC) demonstrated worse clinical outcomes. This might be not unexpected since previous evidence from postmortem studies demonstrated that unstable atherosclerotic plaques are prone to rupture and trigger adverse cardiovascular events.
In recent years, advances in imaging analysis made it possible to conduct novel measurements such as pericoronary inflammation or epicardial fat metrics and lesion-specific or vessel-specific hemodynamic parameters derived from CCTA (such as fractional flow reserve by CCTA [CT-FFR]) as well as the coronary disease patterns defined by physiologic distribution (predominant focal versus diffuse disease defined by CCTA derived pullback pressure gradient index) and local severity (presence versus absence of major gradient defined by CCTA-derived FFR gradient per unit length [dCT-FFR/ds]) of coronary atherosclerosis.
However, the relationship of these parameters and the combination of these indices on clinical outcomes has not been fully understood. Furthermore, though it has been known that high-risk plaques are related with worse outcomes even no significant blood flow impairment induced, best treatment strategy for these lesions remains unclear.
In this regard, the aims of this study are multiple, all the treatment strategies are at the discretion of the physicians in charge. For patients without further invasive angiography performed after CCTA or deferred for revascularization after invasive angiography with/without physiology or imaging assessments, the investigators will investigate coronary atherosclerotic plaque development and progression or regression, as well as the plaque characterization and phenotypes over time by CCTA, and to explore the precursors of plaques leading to acute coronary syndrome (ACS) or chronic coronary syndrome (CCS); for those with received revascularization, the investigators will investigate the prognostic value of CCTA based comprehensive analysis of coronary in combination with physiologic assessment. In all patients, the effects of different treatment strategies according to stenosis and plaque features, fat metrics as well as physiologic assessments will be investigated.
CHART is a study group called Chinese Non-invasive Cardiovascular Imaging and Physiology Study Group, the current study will be conducted by CHART and by invitation in multiple Chinese centers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without ICA or deferral of PCI after ICA group | – | Diagnostic Test: Coronary CT angiographyPatients didn't undergo invasive coronary angiography (ICA) or with a vessel determined to defer revascularization. |
| PCI group | – | Diagnostic Test: Coronary CT angiographyPatients with a vessel that undergo percutaneous coronary intervention (PCI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with an indication for CCTA.
Key inclusion criteria (2 listed)
- Patients with an indication for CCTA.
- Qualified patients who have signed a written informed consent form.
Key exclusion criteria (6 listed)
- Left ventricular ejection fraction < 35%
- Acute ST-elevation myocardial infarction within 72 hours or previous coronary artery bypass graft surgery
- Abnormal epicardial coronary flow (TIMI flow < 3)
- Planned coronary artery bypass graft surgery after diagnostic angiography
- Poor quality of CCTA or other reasons by core lab that are unsuitable for plaque, physiological or fat analysis
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 angiographyCoronary CT angiography (CCTA) will be performed according to standard protocol and measurement of fractional flow reserve (FFR) or other physiological indices will be at the at the discretion of the physicians in charge. Stenosis and plaque features, disease patterns, hemodynamic parameters, and fat metrics on CCTA will be analyzed blindly in the core lab. | Diagnostic test | PCI group, Without ICA or deferral of PCI after ICA group |
Primary outcome
Frequency of occurrence of high-risk plaques
Time frame: 30 days
Frequency (%) of occurrence of high-risk plaque morphologic features (Housfield Unit[HU]<30, Remodelling Index > 1.1, napkin-ring sign, spotty calcium, minimal lumen area[MLA]<4mm2 \& plaque burden[PB]≥70%), physiologic diffuse disease, inflammation by high fat attenuation index (FAI)
Change in total plaque volume (adjusted by vessel volume) and plaque composition detected by follow up CCTA
Time frame: up to 5 years after index procedure
Change in total plaque volume (adjusted by vessel volume) and plaque composition detected by follow up CCTA
Change in WSS detected by follow up CCTA
Time frame: up to 5 years after index procedure
Change in hemodynamic parameter of wall shear stress (WSS) detected by follow up CCTA
Change in APS detected by follow up CCTA
Time frame: up to 5 years after index procedure
Change in hemodynamic parameter of axial plaque stress (APS) detected by follow up CCTA
Change in SSI detected by follow up CCTA
Time frame: up to 5 years after index procedure
Change in stenosis susceptibility index (SSI) detected by follow up CCTA
Change in hemodynamic parameters delta fractional flow reserve detected by follow up CCTA
Time frame: up to 5 years after index procedure
Change in hemodynamic parameters delta fractional flow reserve detected by follow up CCTA
Change in physiological pattern by PPG derived by follow up CCTA
Time frame: up to 5 years after index procedure
Change in physiological pattern by pullback pressure gradient (PPG) derived by follow up CCTA
Change in dCT-FFR/ds detected by follow up CCTA
Time frame: up to 5 years after index procedure
Change in dCT-FFR/ds detected by follow up CCTA
Change in CT-FFR
Time frame: up to 5 years after index procedure
Change in fractional flow reserve by CCTA
Change in peri-coronary adipose tissue assessed by follow up CCTA
Time frame: up to 5 years after index procedure
Change in peri-coronary adipose tissue assessed by follow up CCTA
CCTA-derived features associated with precursors of ACS or CCS
Time frame: up to 5 years after index procedure
CCTA-derived features associated with precursors of ACS or CCS
Adverse cardiovascular event according to stenosis and plaque features, disease patterns, hemodynamic parameters, and fat metrics on CCTA along with physiologic assessment
Time frame: up to 5 years after index procedure
A composite of cardiac death, vessel-related myocardial infarction (MI), or vessel-related ischemia-driven revascularization.
Adverse cardiovascular event according to different treatment strategies according to stenosis and plaque features, fat metrics on CCTA along with physiologic assessments.
Time frame: up to 5 years after index procedure
A composite of cardiac death, vessel-related myocardial infarction (MI), or vessel-related ischemia-driven revascularization.
14 secondary outcomes
Anginal status
Time frame: up to 5 years after index procedure
Number of anti-anginal medication prescribed
Time frame: up to 5 years after index procedure
Clinical predictors of events
Time frame: up to 5 years after index procedure
Prognostic value of CCTA defined anatomy and plaque characterization
Time frame: up to 5 years after index procedure
Prognostic value of WSS
Time frame: up to 5 years after index procedure
Prognostic value of APS
Time frame: up to 5 years after index procedure
Prognostic value of SSI
Time frame: up to 5 years after index procedure
Prognostic value of delta CT-FFR
Time frame: up to 5 years after index procedure
Prognostic value of pull pressure gradient
Time frame: up to 5 years after index procedure
Prognostic value of dCT-FFR/ds
Time frame: up to 5 years after index procedure
Prognostic value of per-coronary adipose tissue
Time frame: up to 5 years after index procedure
Prognostic value of integrated CCTA based lesion anatomy, plaque characterization, hemodynamic parameters, physiological patterns and per-coronary adipose tissue for ACS
Time frame: up to 5 years after index procedure
Prognostic value of integrated CCTA based lesion anatomy, plaque characterization, hemodynamic parameters, physiological patterns and per-coronary adipose tissue for cardiovascular events
Time frame: up to 5 years after index procedure
Relationship among CT-derived plaque qualification and quantification, and CT-defined pericoronary and epicardial fat metrics with physiological assessments.
Time frame: up to 5 years after index procedure
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 25 May 2022.
- Derived from this study: PubMed 39903078Dai N, Tang X, Hu Y, Lu H, Chen Z, Duan S, Guo W, Edavi PP, Yu Y, Huang D, Qian J, Ge J. SARS-CoV-2 Infection Association with Atherosclerotic Plaque Progression at Coronary CT Angiography and Adverse Cardiovascular Events. Radiology. 2025 Feb;314(2):e240876. doi: 10.1148/radiol.240876.
- Individual participant dataSharing planned: Undecided
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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.
Junbo Ge, Professor study chair
Fudan University
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 Coronary Artery Disease, 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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 25 May 2022. 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?
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 Neng Dai, MD (+8613701997266, niceday1987@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of occurrence of high-risk plaques (time frame: 30 days). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05380622, which also lists 1 linked publication.
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 25 May 2022.