- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07577752
Quantifying Blood Flow in the Aorta (AF-4DMRI-P2)
Quantifying Blood Flow in the Aorta Using Phase-Contrast 4D Flow MRI - Phase 2
연구 개요
상태
상세 설명
The goal of this observational study is to obtain PC 4D flow MRI scans in seventy healthy volunteers (without any known history of cardiovascular disease) to quantify local blood flow in the thoraco-abdominal aorta and its primary side branches and extract boundary conditions for future in-vitro and in-silico studies. Furthermore, the 3D geometry of the vessels within investigated FOVs, starting from ascending aorta to internal/external iliac arteries, will be obtained by performing a separate MRI sequence.
Participants will be asked to undergo MRI scans and are asked to fill out a questionnaire regarding their age, weight, height, and gender. By relating this data to the blood flow patterns observed in the aorta, conclusions can be drawn on the differences in blood flow with gender and how aortic blood flow changes with age.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Marleen E. Krommendijk, ir.
- 전화번호: +31534894988
- 이메일: m.e.krommendijk@utwente.nl
연구 장소
-
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Overijssel
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Enschede, Overijssel, 네덜란드, 7522 NH
- 모병
- TechMed centre, University of Twente
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연락하다:
- Cindy D. Lammertink, drs.
- 전화번호: +31534895350
- 이메일: c.d.lammertink@utwente.nl
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부수사관:
- Hadi Mirgolbabaee, dr.
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부수사관:
- Marleen E. Krommendijk, ir.
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Healthy (in particular without any cardiovascular disease or history thereof) men or women
- 18 years of age or above;
- BMI ≤ 30;
- Willingness to undergo MRI scans;
- Able to provide signed informed consent (IC)
Exclusion Criteria:
- Irregular heartbeat.;
- Any history of cardiovascular disease or current cardiovascular disease;
- The standard MRI exclusion criteria (such as pacemakers, cerebral vascular clips, pregnancy, claustrophobia)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Group 1
Five men aged 18-25 and five women aged 18-25
|
Subjects will undergo MRI scans of the thorax and abdomen from which we will derive aortic blood flow velocity fields.
This intervention will be performed in the same manner on all groups.
다른 이름들:
Subjects fill in a questionnaire regarding their weight, height, age and gender.
They also fill in a safety check form to test if MRI can be applied safely.
|
|
Group 2
Five men aged 26-35 and five women aged 26-35
|
Subjects will undergo MRI scans of the thorax and abdomen from which we will derive aortic blood flow velocity fields.
This intervention will be performed in the same manner on all groups.
다른 이름들:
Subjects fill in a questionnaire regarding their weight, height, age and gender.
They also fill in a safety check form to test if MRI can be applied safely.
|
|
Group 3
Five men aged 36-45 and five women aged 36-45
|
Subjects will undergo MRI scans of the thorax and abdomen from which we will derive aortic blood flow velocity fields.
This intervention will be performed in the same manner on all groups.
다른 이름들:
Subjects fill in a questionnaire regarding their weight, height, age and gender.
They also fill in a safety check form to test if MRI can be applied safely.
|
|
Group 4
Five men aged 46-55 and five women aged 46-55
|
Subjects will undergo MRI scans of the thorax and abdomen from which we will derive aortic blood flow velocity fields.
This intervention will be performed in the same manner on all groups.
다른 이름들:
Subjects fill in a questionnaire regarding their weight, height, age and gender.
They also fill in a safety check form to test if MRI can be applied safely.
|
|
Group 5
Five men aged 56-65 and five women aged 56-65
|
Subjects will undergo MRI scans of the thorax and abdomen from which we will derive aortic blood flow velocity fields.
This intervention will be performed in the same manner on all groups.
다른 이름들:
Subjects fill in a questionnaire regarding their weight, height, age and gender.
They also fill in a safety check form to test if MRI can be applied safely.
|
|
Group 6
Five men aged 66-75 and five women aged 66-75
|
Subjects will undergo MRI scans of the thorax and abdomen from which we will derive aortic blood flow velocity fields.
This intervention will be performed in the same manner on all groups.
다른 이름들:
Subjects fill in a questionnaire regarding their weight, height, age and gender.
They also fill in a safety check form to test if MRI can be applied safely.
|
|
Group 7
Five men aged 76-85 and five women aged 76-85
|
Subjects will undergo MRI scans of the thorax and abdomen from which we will derive aortic blood flow velocity fields.
This intervention will be performed in the same manner on all groups.
다른 이름들:
Subjects fill in a questionnaire regarding their weight, height, age and gender.
They also fill in a safety check form to test if MRI can be applied safely.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Aortic blood flow velocity fields
기간: Day 1
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Velocity fields will be acquired, consisting of vectors that describe the velocity magnitude (cm/s) and direction (dimensionless) of blood flow in the aorta.
For visualisation purposes, arrows will be used to overlay the shape of the volunteers aorta.
Colours of the arrrows indicate the velocity magnitude and direction of the arrows inicate the direction of flow.
Velocity fields are generated for the the full aorta, from the ascending aorta to internal/external iliac arteries, including branched arteries such as subclavian arteries, common carotid artery, and visceral branch vessels.
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Day 1
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Age of volunteer
기간: Day 1
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Age of volunteer (in years) for division into groups based on gender and age, gathered using a questionnaire.
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Day 1
|
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Gender of volunteer
기간: Day 1
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Gender of volunteer (male/female/other) for division into groups based on gender and age, gathered using a questionnaire.
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Day 1
|
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Height of volunteer
기간: Day 1
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Height (in m) for BMI (in kg/m^2) calculation, gathered using a questionnaire.
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Day 1
|
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Weight of volunteer
기간: Day 1
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Weight (in kg) for BMI (in kg/m^2) calculation, gathered using a questionnaire.
|
Day 1
|
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Aortic blood flow waveforms
기간: Day 1
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Waveforms will be acquired that show how aortic blood flow in a certain region of interest progresses over the cardiac cycle, presented as plots of velocity magnitude (cm/s) over time (s).
Regions of interest are selected in the ascending aorta, descending aorta, carotid arteries, subclavian arteries, renal arteries, suprarenal aorta, abdominal aorta, common iliac arteries, internal iliac arteries, and external iliac arteries.
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Day 1
|
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Wall shear stress
기간: Day 1
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Wall shear stress (Pa) is a hemodynamic parameter expressing the force acting on a certain area of the vessel wall by the flow of blood.
This parameter will be extracted from the blood flow velocity vectors in a certain region of interest (e.g. in the ascending aorta, descending aorta, renal arteries, or iliac arteries) and will be plotted over the cardiac cycle.
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Day 1
|
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Oscillatory Shear Index
기간: Day 1
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Oscillatory Shear Index (dimensionless) is a hemodynamic parameter that defines how much the wall shear stress field changes directions over time, which can tell something about whether the forces on the wall (and the flow of blood) are more uniform or more complex.
This parameter will be extracted from the blood flow velocity vectors in a certain region of interest (e.g. in the ascending aorta, descending aorta, renal arteries, or iliac arteries) and will be plotted over the cardiac cycle.
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Day 1
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Kinetic Energy
기간: Day 1
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Kinetic Energy (J) in the field of fluid mechanics describes the energy related to the flow of blood in a certain region of interest with a certain mass or volume.
This parameter will be extracted from the blood flow velocity vectors in a certain region of interest (e.g. in the ascending aorta, descending aorta, renal arteries, or iliac arteries) and will be plotted over the cardiac cycle.
|
Day 1
|
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Turbulent Kinetic Energy
기간: Day 1
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Turbulent Kinetic Energy (J/kg) is a hemodynamic parameter describing the energy related to the fluctuations in blood flow velocity.
This parameter will be extracted from the blood flow velocity vectors in a certain region of interest (e.g. in the ascending aorta, descending aorta, renal arteries, or iliac arteries) and will be plotted over the cardiac cycle.
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Day 1
|
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Helicity
기간: Day 1
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Helicity (m^4/s^2) is a hemodynamic parameter that describes how much the blood flow follows a corkscrew-like pattern.
This parameter will be extracted from the blood flow velocity vectors in a certain region of interest (e.g. in the ascending aorta, descending aorta, renal arteries, or iliac arteries) and will be plotted over the cardiac cycle.
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Day 1
|
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Vorticity
기간: Day 1
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Vorticity (s^-1) is a hemodynamic parameter that reflects the rotational nature of the blood flow.
This parameter will be extracted from the blood flow velocity vectors in a certain region of interest (e.g. in the ascending aorta, descending aorta, renal arteries, or iliac arteries) and will be plotted over the cardiac cycle.
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Day 1
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공동 작업자 및 조사자
수사관
- 수석 연구원: Michel M.P.J. Reijnen, prof. dr., University of Twente
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- AF-4DMRI-P2
- NL88490.091.25 (기타 식별자: Centrale Commissie Mensgebonden Onderzoek (CCMO))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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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