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.
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Daegu, 대한민국
- Keimyung University Dongsan Medical Center
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Goyang, 대한민국
- Inje University Ilsan Paik Hospital
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Seoul, 대한민국
- Seoul National University Hospital
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Ulsan, 대한민국
- Ulsan University Hospital, University of Ulsan College of Medicine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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
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Optical coherence tomography to evaluate plaque morphology and vulnerable features (ex> cap thickness, spotty calcification)
다른 이름들:
Resting and hyperemic pressure pullback tracing will be done with motorized pullback system.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Axial plaque stress (Axial component of total traction acting on the plaque)
기간: up to 1 week
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up to 1 week
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Cap thickness (measured from optical coherent tomography)
기간: up to 1 week
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Cap thickness measured from optical coherent tomography
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up to 1 week
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Wall shear stress (Friction vector on the surface of the plaque)
기간: up to 1 week
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Friction vector on the surface of the plaque
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up to 1 week
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Proportion of thin cap fibrous atheroma
기간: up to 1 week
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Plaques with cap thickness < 60um
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up to 1 week
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Cardiac death and all-cause mortality
기간: 1 year
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Between High-hemodynamic force plaque and Low-hemodynamic force plaque
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1 year
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Non-fatal target vessel myocardial infarction
기간: 1 year
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Between High-hemodynamic force plaque and Low-hemodynamic force plaque
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1 year
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Target vessel restenosis
기간: 1 year
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Between High-hemodynamic force plaque and Low-hemodynamic force plaque
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1 year
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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