Invasive Measurement of Axial Plaque Stress, the Pilot Study

Coronary Artery Disease Clinical Trial

— REASSURE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02388399
• Other study ID #: NCT723631
• Status: Not yet recruiting
• Phase: N/A
• First received: March 4, 2015
• Last updated: March 9, 2015
• Start date: March 2015
• Est. completion date: March 2018

Study information

• Verified date: March 2015
• Source: Seoul National University Hospital
• Contact: Bon-Kwon Koo, MD, PhD
• Phone: 82-2-2072-2062
• Email: bkkoo[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Device
Optical coherence tomography to evaluate plaque morphology and vulnerable features (ex> cap thickness, spotty calcification)
• Device
Resting and hyperemic pressure pullback tracing will be done with motorized pullback system.

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Inje University Ilsan Paik Hospital	Goyang
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Ulsan University Hospital, University of Ulsan College of Medicine	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axial plaque stress (Axial component of total traction acting on the plaque)		up to 1 week	No
Primary	Cap thickness (measured from optical coherent tomography)	Cap thickness measured from optical coherent tomography	up to 1 week	No
Secondary	Wall shear stress (Friction vector on the surface of the plaque)	Friction vector on the surface of the plaque	up to 1 week	No
Secondary	Proportion of thin cap fibrous atheroma	Plaques with cap thickness < 60um	up to 1 week	No
Secondary	Cardiac death and all-cause mortality	Between High-hemodynamic force plaque and Low-hemodynamic force plaque	1 year	No
Secondary	Non-fatal target vessel myocardial infarction	Between High-hemodynamic force plaque and Low-hemodynamic force plaque	1 year	No
Secondary	Target vessel restenosis	Between High-hemodynamic force plaque and Low-hemodynamic force plaque	1 year	No