Quantifying Blood Flow in the Aorta (AF-4DMRI-P2)
2026年5月4日 更新者：Marleen Krommendijk、University of Twente
Quantifying Blood Flow in the Aorta Using Phase-Contrast 4D Flow MRI - Phase 2
This study aims to gain insights into aortic blood flow in healthy volunteers using PC 4D-flow MRI
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (推定)
70
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Marleen E. Krommendijk, ir.
- 電話番号：+31534894988
- メール：m.e.krommendijk@utwente.nl
研究場所
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Overijssel
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Enschede、Overijssel、オランダ、7522 NH
- 募集
- TechMed centre, University of Twente
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コンタクト：
- Cindy D. Lammertink, drs.
- 電話番号：+31534895350
- メール：c.d.lammertink@utwente.nl
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副調査官：
- Hadi Mirgolbabaee, dr.
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副調査官：
- Marleen E. Krommendijk, ir.
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
サンプリング方法
非確率サンプル
調査対象母集団
Healthy subjects with no known cardiovascular disease or history thereof
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Group 1
Five men aged 18-25 and five women aged 18-25
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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.
他の名前：
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.
他の名前：
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.
他の名前：
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.
他の名前：
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.
他の名前：
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.
他の名前：
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.
他の名前：
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Aortic blood flow velocity fields
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Age of volunteer
時間枠：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
時間枠：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
時間枠：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
時間枠：Day 1
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Weight (in kg) for BMI (in kg/m^2) calculation, gathered using a questionnaire.
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Day 1
|
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Aortic blood flow waveforms
時間枠：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.
|
Day 1
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Wall shear stress
時間枠：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
時間枠：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
時間枠：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
時間枠：Day 1
|
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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Michel M.P.J. Reijnen, prof. dr.、University of Twente
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2026年7月31日
研究の完了 (推定)
2027年7月31日
試験登録日
最初に提出
2026年3月17日
QC基準を満たした最初の提出物
2026年5月4日
最初の投稿 (実際)
2026年5月11日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月11日
QC基準を満たした最後の更新が送信されました
2026年5月4日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- AF-4DMRI-P2
- NL88490.091.25 (その他の識別子：Centrale Commissie Mensgebonden Onderzoek (CCMO))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
4D-flow Magnetic Resonance Imagingの臨床試験
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Germans Trias i Pujol Hospital完了虚血性脳卒中 | 磁気共鳴画像 | 動脈閉塞 | CTSスペイン
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IRCCS Policlinico S. Donato募集
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Assistance Publique - Hôpitaux de ParisSorbonne University; Institute of Cardiometabolism and Nutrition, Franceまだ募集していません