Acute Coronary SyndromePVCFDNCT04524117
Prediction of Vulnerable Plaque Using Coronary CT Angiography and Computational Fluid Dynamic in Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome and Plaque, Atherosclerotic, run by Shanghai 10th People's Hospital.
Trial summary
The aim of the PVCFD trial is to predict vulnerable plaque confirmed by OCT using coronary CT angiography and computational fluid dynamics in patients with acute coronary syndrome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome, Plaque, Atherosclerotic
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 1 Dec 2022
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with acute coronary syndrome
Who may be able to join
- 1)acute coronary syndrome was diagnosed according to universal definition of ACS; and 2) coronary CTA was completed before CAG; and 3) definitely culprit lesion can be recognized by CAG; 4) OCT was done to detect coronary atherosclerotic plaques confirmed by CAG.
Who cannot join
- 1) Previous history stent implantation; 2) previous history of coronary artery bypass graft surgery; 3) ACS without clear culprit lesion; 4) poor image quality of coronary CTA for APC and CFD analysis; 5) myocardial infarction secondary to other reasons
Trial locations and contacts
No sites are listed yet.
About this study
The aim of the PVCFD trial is to predict vulnerable plaque confirmed by OCT using coronary CT angiography and computational fluid dynamics in patients with acute coronary syndrome.
Read the detailed description
Acute coronary syndrome（ACS）mainly includes unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction, which is the leading cause of death around the world. The main pathophysiological feature of ACS is the rupture of vulnerable plaque, which can be recognized by coronary artery angiography (CAG), intravascular ultrasound (IVUS) and optical coherence tomography (OCT). Compared with CAG and IVUS, OCT is the best intravascular imaging technique so far. But all these examinations are invasive and expensive. Recently, coronary CT angiography derived adverse plaque characteristics (APC) and hemodynamic forces defined by computational fluid dynamics (CFD) can reflect plaque vulnerability and hemodynamic forces acting on the plaque, which are important factors in the progress of the rupture of vulnerable plaque. So, we want to explore predictive value of coronary CT angiography (CTA)and computational fluid dynamics for vulnerable plaque in ACS.
The PVCFD trial is a prospective and single center study, patients with ACS will be arranged to complete coronary CTA before CAG. OCT will be used to detect the characteristics of coronary atherosclerotic plaques confirmed by CAG. Lipid plaques with fibrous cap thickness less than 65um, erosion and coronary artery dissection are defined as vulnerable plaque. Patients will be divided into vulnerable plaque group and stable plaque group according to this. The coronary CTA images will be screened for APC and CFD analyses at core laboratories of Shanghai tenth's hospital. Lesions with diameter stenosis (DS) >30% based on coronary CTA evaluation were included for subsequent APC (low-attenuation plaque, positive remodeling, napkin-ring sign, and spotty calcification) analysis and hemodynamic forces (FFRCT,ΔFFRCT, WSS and PWS) defined by CFD. Three prediction models (Model 1: percent diameter stenosis + lesion length, Model 2: Model 1 + APC, Model 3: Model 2 + hemodynamic force) will be constructed to identify vulnerable plaque confirmed by OCT.
- Conditions
- Acute Coronary Syndrome, Plaque, Atherosclerotic
- Medical subject headings
- Acute Coronary Syndrome, Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A(vulnerable plaque group) | Lipid plaques with fibrous cap thickness less than 65um, erosion and coronary artery dissection detected by OCT are defined as vulnerable plaque. | |
| Group B(stable plaque group) | Lipid plaques with fibrous cap thickness more than 65um detected by OCT are defined as vulnerable plaque. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of area under curve among the three prediction models
Measured: from 1 to 72 hours
The difference of net reclassification index (NRI) and integrated discrimination improvement (IDI) among the three prediction models
Measured: from 1 to 72 hours
Secondary outcomes (3)
The percentage in APC (low-attenuation plaque, positive remodeling, napkin-ring sign, and spotty calcification) between the vulnerable plaque group and stable plaque group
Measured: from 1 to 72 hours
The difference in hemodynamic parameters (FFRCT,ΔFFRCT, WSS and PWS) between the vulnerable plaque group and stable plaque group
Measured: from 1 to 72 hours
The optimal cut-off values of hemodynamic parameters (FFRCT,ΔFFRCT, WSS and PWS) to identify vulnerable plaque
Measured: from 1 to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524117
- Sponsor's protocol ID
- PVCFD
- Acronym
- PVCFD
- Status last verified
- Aug 2020
- First submitted
- 19 Aug 2020
- Last updated
- 24 Aug 2020
- 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 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Vulnerable Plaque Using Coronary CT Angiography and Computational Fluid Dynamic in Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT04524117
- Acronym / sponsor ID
- PVCFD / PVCFD
- Conditions
- Acute Coronary Syndrome, Plaque, Atherosclerotic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 24 Aug 2020 (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 aim of the PVCFD trial is to predict vulnerable plaque confirmed by OCT using coronary CT angiography and computational fluid dynamics in patients with acute coronary syndrome.
Detailed description
Acute coronary syndrome（ACS）mainly includes unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction, which is the leading cause of death around the world. The main pathophysiological feature of ACS is the rupture of vulnerable plaque, which can be recognized by coronary artery angiography (CAG), intravascular ultrasound (IVUS) and optical coherence tomography (OCT). Compared with CAG and IVUS, OCT is the best intravascular imaging technique so far. But all these examinations are invasive and expensive. Recently, coronary CT angiography derived adverse plaque characteristics (APC) and hemodynamic forces defined by computational fluid dynamics (CFD) can reflect plaque vulnerability and hemodynamic forces acting on the plaque, which are important factors in the progress of the rupture of vulnerable plaque. So, we want to explore predictive value of coronary CT angiography (CTA)and computational fluid dynamics for vulnerable plaque in ACS.
The PVCFD trial is a prospective and single center study, patients with ACS will be arranged to complete coronary CTA before CAG. OCT will be used to detect the characteristics of coronary atherosclerotic plaques confirmed by CAG. Lipid plaques with fibrous cap thickness less than 65um, erosion and coronary artery dissection are defined as vulnerable plaque. Patients will be divided into vulnerable plaque group and stable plaque group according to this. The coronary CTA images will be screened for APC and CFD analyses at core laboratories of Shanghai tenth's hospital. Lesions with diameter stenosis (DS) >30% based on coronary CTA evaluation were included for subsequent APC (low-attenuation plaque, positive remodeling, napkin-ring sign, and spotty calcification) analysis and hemodynamic forces (FFRCT,ΔFFRCT, WSS and PWS) defined by CFD. Three prediction models (Model 1: percent diameter stenosis + lesion length, Model 2: Model 1 + APC, Model 3: Model 2 + hemodynamic force) will be constructed to identify vulnerable plaque confirmed by OCT.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A(vulnerable plaque group) | – | –Lipid plaques with fibrous cap thickness less than 65um, erosion and coronary artery dissection detected by OCT are defined as vulnerable plaque. |
| Group B(stable plaque group) | – | –Lipid plaques with fibrous cap thickness more than 65um detected by OCT are defined as vulnerable plaque. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with acute coronary syndrome
Key inclusion criteria (1 listed)
- 1)acute coronary syndrome was diagnosed according to universal definition of ACS; and 2) coronary CTA was completed before CAG; and 3) definitely culprit lesion can be recognized by CAG; 4) OCT was done to detect coronary atherosclerotic plaques confirmed by CAG.
Key exclusion criteria (1 listed)
- 1) Previous history stent implantation; 2) previous history of coronary artery bypass graft surgery; 3) ACS without clear culprit lesion; 4) poor image quality of coronary CTA for APC and CFD analysis; 5) myocardial infarction secondary to other reasons
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
The difference of area under curve among the three prediction models
Time frame: from 1 to 72 hours
The difference of net reclassification index (NRI) and integrated discrimination improvement (IDI) among the three prediction models
Time frame: from 1 to 72 hours
3 secondary outcomes
The percentage in APC (low-attenuation plaque, positive remodeling, napkin-ring sign, and spotty calcification) between the vulnerable plaque group and stable plaque group
Time frame: from 1 to 72 hours
The difference in hemodynamic parameters (FFRCT,ΔFFRCT, WSS and PWS) between the vulnerable plaque group and stable plaque group
Time frame: from 1 to 72 hours
The optimal cut-off values of hemodynamic parameters (FFRCT,ΔFFRCT, WSS and PWS) to identify vulnerable plaque
Time frame: from 1 to 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Plaque, Atherosclerotic, run by Shanghai 10th People's Hospital.
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 1 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 24 Aug 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenhui Peng, PhD (13764648639 ext. +86, pwenhui@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of area under curve among the three prediction models (time frame: from 1 to 72 hours). The study lists 2 primary outcomes in all. 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 24 Aug 2020.