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Invasive Measurement of Axial Plaque Stress, the Pilot Study

Conditions
Coronary Artery Disease
Interventions
Procedure: Device
Registration Number
NCT02388399
Lead Sponsor
Seoul National University Hospital
Brief Summary

In this study, the investigators sought to evaluate the feasibility of estimating external hemodynamic stress acting plaque with the use of invasively measured hemodynamic data from pressure wire pullback tracing.

In addition, the investigators will also evaluate detailed plaque geometry and vulnerability using optical coherence tomography along with the hemodynamic stress.

Detailed Description

It has been well known that mechanism of acute coronary syndrome is plaque rupture and occlusion of coronary artery by this plaque rupture. Although current risk assessment for plaque rupture have mainly focused on evaluation of plaque vulnerability. However, according to the general mechanism of material failure, plaque rupture occurs whenever the external hemodynamic stress exceeds the durability of the plaque.

Recently, we evaluated the axial plaque stress, which is axial component of total traction acting on the plaque, and showed that the axial plaque stress possess significantly higher magnitude than previously known wall shear stress.

However, the axial plaque stress in our previous research was measured with computational flow dynamics analysis using coronary artery model from coronary CT angiography.

In this study, we sought to evaluate the feasibility of estimating external hemodynamic stress acting plaque with the use of invasively measured hemodynamic data from pressure wire pullback tracing.

In addition, we will also evaluate detailed plaque geometry and vulnerability using optical coherence tomography along with the hemodynamic stress.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
100
Inclusion Criteria
    1. Patients with angina pectoris who are scheduled to do invasive coronary angiography.
    1. Patients who have moderate (40-70%) stenosis at proximal or mid-portion of major coronary arteries.
    1. Pressure wire pullback tracing and Optical Coherence Tomography ware successfully performed
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Exclusion Criteria
    1. Stenosis at distal coronary or small vessel.
    1. Patients who don't have moderate (40-70%) stenosis at proximal or mid-portion of major coronary arteries. Confirmed by invasive coronary angiography.
    1. Inadequate quality of Optical Coherence Tomography
    1. No data of Fractional Flow Reserve or Pressure wire pullback tracing or inadequate data of Fractional Flow Reserve or Pressure wire pullback tracing
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
OCT and Pressure wire pullback tracingDeviceThis study is pilot study evaluating the feasibility of invasive measurement and estimation of hemodynamic stress acting on plaque as well as co-registration of hemodynamic data with plaque geometric data, which is obtained by optical coherence tomography
Primary Outcome Measures
NameTimeMethod
Cap thickness (measured from optical coherent tomography)up to 1 week

Cap thickness measured from optical coherent tomography

Axial plaque stress (Axial component of total traction acting on the plaque)up to 1 week
Secondary Outcome Measures
NameTimeMethod
Proportion of thin cap fibrous atheromaup to 1 week

Plaques with cap thickness \< 60um

Target vessel restenosis1 year

Between High-hemodynamic force plaque and Low-hemodynamic force plaque

Wall shear stress (Friction vector on the surface of the plaque)up to 1 week

Friction vector on the surface of the plaque

Non-fatal target vessel myocardial infarction1 year

Between High-hemodynamic force plaque and Low-hemodynamic force plaque

Cardiac death and all-cause mortality1 year

Between High-hemodynamic force plaque and Low-hemodynamic force plaque

Trial Locations

Locations (4)

Inje University Ilsan Paik Hospital

🇰🇷

Goyang, Korea, Republic of

Keimyung University Dongsan Medical Center

🇰🇷

Daegu, Korea, Republic of

Seoul National University Hospital

🇰🇷

Seoul, Korea, Republic of

Ulsan University Hospital, University of Ulsan College of Medicine

🇰🇷

Ulsan, Korea, Republic of

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