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

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Device; Procedure: Device

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with angina pectoris

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OCT and Pressure wire pullback tracing; 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	Procedure: Device; Optical coherence tomography to evaluate plaque morphology and vulnerable features (ex> cap thickness, spotty calcification); Other Names: Optical coherence tomography; Procedure: Device; Resting and hyperemic pressure pullback tracing will be done with motorized pullback system.; Other Names: Fractional flow reserve measurement with pressure pullback tracing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial plaque stress (Axial component of total traction acting on the plaque)		up to 1 week
Cap thickness (measured from optical coherent tomography)	Cap thickness measured from optical coherent tomography	up to 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wall shear stress (Friction vector on the surface of the plaque)	Friction vector on the surface of the plaque	up to 1 week
Proportion of thin cap fibrous atheroma	Plaques with cap thickness < 60um	up to 1 week
Cardiac death and all-cause mortality	Between High-hemodynamic force plaque and Low-hemodynamic force plaque	1 year
Non-fatal target vessel myocardial infarction	Between High-hemodynamic force plaque and Low-hemodynamic force plaque	1 year
Target vessel restenosis	Between High-hemodynamic force plaque and Low-hemodynamic force plaque	1 year

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: March 4, 2015
• First Submitted That Met QC Criteria: March 9, 2015
• First Posted (Estimate): March 17, 2015

Study Record Updates

• Last Update Posted (Estimate): March 17, 2015
• Last Update Submitted That Met QC Criteria: March 9, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Optical coherence tomography; Vulnerability; Axial Plaque Stress; Wall Shear Stress
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: NCT723631