Prediction of Vulnerable Plaque Using Coronary CT Angiography and Computational Fluid Dynamic in Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— PVCFD  

Official title:

Prediction of Vulnerable Plaque Using Coronary CT Angiography and Computational Fluid Dynamic in Acute Coronary Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04524117
• Other study ID #: PVCFD
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Plaque, Atherosclerotic
• Syndrome

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