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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04524117
Other study ID # PVCFD
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date December 1, 2022

Study information

Verified date August 2020
Source Shanghai 10th People's Hospital
Contact Wenhui Peng, PhD
Phone 13764648639
Email pwenhui@tongji.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date December 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shanghai 10th People's Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary The difference of area under curve among the three prediction models from 1 to 72 hours
Primary The difference of net reclassification index (NRI) and integrated discrimination improvement (IDI) among the three prediction models from 1 to 72 hours
Secondary The percentage in APC (low-attenuation plaque, positive remodeling, napkin-ring sign, and spotty calcification) between the vulnerable plaque group and stable plaque group from 1 to 72 hours
Secondary The difference in hemodynamic parameters (FFRCT,?FFRCT, WSS and PWS) between the vulnerable plaque group and stable plaque group from 1 to 72 hours
Secondary The optimal cut-off values of hemodynamic parameters (FFRCT,?FFRCT, WSS and PWS) to identify vulnerable plaque from 1 to 72 hours
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