Invasive Measurement of Axial Plaque Stress, the Pilot Study (REASSURE)

Seoul National University

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Procedure: Device

Study type: Observational

Funder types: Other

Identifiers

NCT02388399

NCT723631

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Patients with angina pectoris who are scheduled to do invasive coronary angiography.
• 2. Patients who have moderate (40-70%) stenosis at proximal or mid-portion of major coronary arteries.
• 3. Pressure wire pullback tracing and Optical Coherence Tomography ware successfully performed

Exclusion criteria

• 1. Stenosis at distal coronary or small vessel.
• 2. Patients who don't have moderate (40-70%) stenosis at proximal or mid-portion of major coronary arteries. Confirmed by invasive coronary angiography.
• 3. Inadequate quality of Optical Coherence Tomography
• 4. No data of Fractional Flow Reserve or Pressure wire pullback tracing or inadequate data of Fractional Flow Reserve or Pressure wire pullback tracing

Trial design

100 participants in 1 patient group

OCT and Pressure wire pullback tracing

Description:

This 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

Treatment:

Procedure: Device

Procedure: Device