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Invasive Measurement of Axial Plaque Stress, the Pilot Study

Relevance of Invasively Measured Axial Plaque Stress and Wall Shear Stress Using Invasive Coronary Imaging and Hemodynamic Data

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02388399
Acronym
REASSURE
Enrollment
100
Registered
2015-03-17
Start date
2015-03-31
Completion date
2018-03-31
Last updated
2015-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Optical coherence tomography, Axial Plaque Stress, Wall Shear Stress, Vulnerability

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.

Interventions

PROCEDUREDevice

Optical coherence tomography to evaluate plaque morphology and vulnerable features (ex\> cap thickness, spotty calcification)

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Axial plaque stress (Axial component of total traction acting on the plaque)up to 1 week
Cap thickness (measured from optical coherent tomography)up to 1 weekCap thickness measured from optical coherent tomography

Secondary

MeasureTime frameDescription
Cardiac death and all-cause mortality1 yearBetween High-hemodynamic force plaque and Low-hemodynamic force plaque
Proportion of thin cap fibrous atheromaup to 1 weekPlaques with cap thickness \< 60um
Target vessel restenosis1 yearBetween High-hemodynamic force plaque and Low-hemodynamic force plaque
Non-fatal target vessel myocardial infarction1 yearBetween High-hemodynamic force plaque and Low-hemodynamic force plaque
Wall shear stress (Friction vector on the surface of the plaque)up to 1 weekFriction vector on the surface of the plaque

Countries

South Korea

Contacts

Primary ContactBon-Kwon Koo, MD, PhD
bkkoo@snu.ac.kr82-2-2072-2062
Backup ContactJoo Myung Lee, MD, MPH
drone80@hanmail.net82-2-2072-2062

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026