Clinical trial NCT02388399: Invasive Measurement of Axial Plaque Stress, the Pilot Study
Official title: Relevance of Invasively Measured Axial Plaque Stress and Wall Shear Stress Using Invasive Coronary Imaging and Hemodynamic Data
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: Optical coherence tomography
Axial Plaque Stress
Wall Shear Stress
Vulnerability
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with angina pectoris

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.

Eligibility criteria: 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

Primary outcomes:
measure: Axial plaque stress (Axial component of total traction acting on the plaque)
timeFrame: up to 1 week
measure: Cap thickness (measured from optical coherent tomography)
timeFrame: up to 1 week
Secondary outcomes:
measure: Wall shear stress (Friction vector on the surface of the plaque)
timeFrame: up to 1 week
measure: Proportion of thin cap fibrous atheroma
timeFrame: up to 1 week
measure: Cardiac death and all-cause mortality
timeFrame: 1 year
measure: Non-fatal target vessel myocardial infarction
timeFrame: 1 year
measure: Target vessel restenosis
timeFrame: 1 year
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Goyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital, University of Ulsan College of Medicine
Study officials:
affiliation: Seoul National University Hospital
name: Bon-Kwon Koo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: