Coronary Artery DiseaseREASSURENCT02388399
Invasive Measurement of Axial Plaque Stress, the Pilot Study
An observational study of Coronary Artery Disease, run by Seoul National University Hospital at 4 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Device
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Mar 2015to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with angina pectoris
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Keimyung University Dongsan Medical Center
Daegu
Chang-Wook Nam, MD, PhD, ncwcv@dsmc.or.kr
Chang-Wook Nam, MD, PhD
Inje University Ilsan Paik Hospital
Goyang
Joon-Hyung Doh, MD, PhD, joon.doh@gmail.com
Joon-Hyung Doh, MD, PhD
Seoul National University Hospital
Seoul
Bon-Kwon Koo, MD, PhD, bkkoo@snu.ac.kr
Joo Myung Lee, MD, MPH, drone80@hanmail.net
Ulsan University Hospital, University of Ulsan College of Medicine
Ulsan
Eun-Seok Shin, MD, PhD, ses@uuh.ulsan.kr
Eun-Seok Shin, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Device
- Keywords
- Optical coherence tomography, Axial Plaque Stress, Wall Shear Stress, Vulnerability
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeviceProcedure or surgery
Also called Optical coherence tomography
Optical coherence tomography to evaluate plaque morphology and vulnerable features (ex> cap thickness, spotty calcification)
DeviceProcedure or surgery
Also called Fractional flow reserve measurement with pressure pullback tracing
Resting and hyperemic pressure pullback tracing will be done with motorized pullback system.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial plaque stress (Axial component of total traction acting on the plaque)
Measured: up to 1 week
Cap thickness (measured from optical coherent tomography)
Cap thickness measured from optical coherent tomography
Measured: up to 1 week
Secondary outcomes (5)
Wall shear stress (Friction vector on the surface of the plaque)
Friction vector on the surface of the plaque
Measured: up to 1 week
Proportion of thin cap fibrous atheroma
Plaques with cap thickness < 60um
Measured: up to 1 week
Cardiac death and all-cause mortality
Between High-hemodynamic force plaque and Low-hemodynamic force plaque
Measured: 1 year
Non-fatal target vessel myocardial infarction
Between High-hemodynamic force plaque and Low-hemodynamic force plaque
Measured: 1 year
Target vessel restenosis
Between High-hemodynamic force plaque and Low-hemodynamic force plaque
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bon-Kwon Koo, Seoul National University Hospital
- Investigators
- Bon-Kwon Koo, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388399
- Sponsor's protocol ID
- NCT723631
- Acronym
- REASSURE
- Status last verified
- Mar 2015
- First submitted
- 4 Mar 2015
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relevance of Invasively Measured Axial Plaque Stress and Wall Shear Stress Using Invasive Coronary Imaging and Hemodynamic Data
- ClinicalTrials.gov ID
- NCT02388399
- Acronym / sponsor ID
- REASSURE / NCT723631
- Conditions
- Coronary Artery Disease
- Keywords
- Optical coherence tomography, Axial Plaque Stress, Wall Shear Stress, Vulnerability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCT and Pressure wire pullback tracing | – | Procedure: DeviceThis 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with angina pectoris
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeviceAlso: Optical coherence tomographyOptical coherence tomography to evaluate plaque morphology and vulnerable features (ex> cap thickness, spotty calcification) | Procedure or surgery | OCT and Pressure wire pullback tracing |
| DeviceAlso: Fractional flow reserve measurement with pressure pullback tracingResting and hyperemic pressure pullback tracing will be done with motorized pullback system. | Procedure or surgery | OCT and Pressure wire pullback tracing |
Primary outcome
Axial plaque stress (Axial component of total traction acting on the plaque)
Time frame: up to 1 week
Cap thickness (measured from optical coherent tomography)
Time frame: up to 1 week
Cap thickness measured from optical coherent tomography
5 secondary outcomes
Wall shear stress (Friction vector on the surface of the plaque)
Time frame: up to 1 week
Proportion of thin cap fibrous atheroma
Time frame: up to 1 week
Cardiac death and all-cause mortality
Time frame: 1 year
Non-fatal target vessel myocardial infarction
Time frame: 1 year
Target vessel restenosis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bon-Kwon Koo, MD, PhD principal investigator
Seoul National University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Seoul National University Hospital at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bon-Kwon Koo, MD, PhD (82-2-2072-2062, bkkoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial plaque stress (Axial component of total traction acting on the plaque) (time frame: up to 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.