Invasive Measurement of Axial Plaque Stress, the Pilot Study

NCT02388399 | Unknown

• 1 other identifier: NCT723631
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Wall shear stress (Friction vector on the surface of the plaque)

  up to 1 week

• Proportion of thin cap fibrous atheroma

  up to 1 week

• Cardiac death and all-cause mortality

  1 year

• Non-fatal target vessel myocardial infarction

  1 year

• Target vessel restenosis

  1 year

Study Arms (1)

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

Interventions

Device PROCEDURE

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

Also known as: Optical coherence tomography

OCT and Pressure wire pullback tracing

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with angina pectoris

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (4)

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Ulsan University Hospital, University of Ulsan College of Medicine

Ulsan, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Equipment and Supplies; Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Bon-Kwon Koo, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bon-Kwon Koo, MD, PhD

CONTACT

82-2-2072-2062; bkkoo@snu.ac.kr

Joo Myung Lee, MD, MPH

CONTACT

82-2-2072-2062; drone80@hanmail.net

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine and Cardiology Deparment

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 17, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2018
• Last Updated: March 17, 2015

Record last verified: 2015-03

Locations

KR (4)