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

NCT04524117 | Unknown

• 1 other identifier: PVCFD
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acute Coronary Syndrome; Plaque, Atherosclerotic

Outcome Measures

Primary Outcomes (2)

• The difference of area under curve among the three prediction models

  from 1 to 72 hours

• The difference of net reclassification index (NRI) and integrated discrimination improvement (IDI) among the three prediction models

  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

  from 1 to 72 hours

• The difference in hemodynamic parameters (FFRCT,ΔFFRCT, WSS and PWS) between the vulnerable plaque group and stable plaque group

  from 1 to 72 hours

• The optimal cut-off values of hemodynamic parameters (FFRCT,ΔFFRCT, WSS and PWS) to identify vulnerable plaque

  from 1 to 72 hours

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with acute coronary syndrome

You may qualify if:

• )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.

You may not qualify if:

• \) 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

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

MeSH Terms

Conditions

Acute Coronary Syndrome; Plaque, Atherosclerotic

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wenhui Peng, PhD

CONTACT

13764648639; pwenhui@tongji.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, pHD, Director of Cardiovascular Department

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 24, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 24, 2020

Record last verified: 2020-08