Influence of Contrast Injection Force on the Accuracy of Vessel Measurements in Cerebral Angiography
調査の概要
詳細な説明
Research for this study is to determine how the injection of contrast material influences vessel measurements, as these measurements guide device selection when interventions are warranted.
The data will be used to determine if there is a significant change in vessel diameter with intra-arterial injection of contrast material in cerebral angiography, how changes in force of contrast injection augments the significance of the changes in vessel geometry, and the extent of propagation downstream from the catheter tip that such changes in vessel diameter are detected and found to be significant, as these changes could potentially lead to less optimal device selection by providing an overestimation of true vessel diameter.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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North Carolina
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Winston-Salem、North Carolina、アメリカ、27157
- Wake Forest University Health Sciences
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Patients receiving care at WFBMC that will be undergoing a standard of care cerebral angiogram that are anticipated to have multiple images per standard view (a minimum of 2 images for an individual view required for the necessary data collection).
Patients that are anticipated to have less than 2 images for each standard view collected from their cerebral angiogram.
説明
Inclusion Criteria:
- Patients receiving care at WFBMC that will be undergoing a standard of care cerebral angiogram who are anticipated to have a minimum of 2 images for an individual view required for the necessary data collection
Exclusion Criteria:
- Patients who are anticipated to have less than 2 images for each standard view collected from their cerebral angiogram.
研究計画
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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Standard of Care Cerebral Angiogram Group
Participants undergoing a standard of care cerebral angiogram.
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Subjects will undergo the standard of care cerebral angiogram and any intervention(s) (when applicable) that were discussed with their provider, following the standard procedural protocol for the procedure at WFBMC. There are no additional interventions or changes to the planned intervention(s) that will take place by agreeing to participate in the study. The data collected from this procedure, following the standard of care protocol, will include the following: force of injection of contrast material for each angiographic run (peak pressure associated with injection, duration of peak, and area under pressure curve), volume of contrast utilized, images from the procedure, measurements of vessel diameter at defined distances from the catheter tip utilizing the images, catheter type, any additional device(s) (when applicable) utilized during the procedure, and if spasmolytic agents are utilized (including dose and time of administration). |
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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Peak pressure associated with injection
時間枠：During procedure, up to 10 minutes
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The effort force of injection will be measured and recorded for each run using a standard arterial line pressure transducer setup that attaches to the guide catheter, with data acquired via Mediocollector (a program that allows for quantitative recording of data.
The duration of peak pressure will be collected.
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During procedure, up to 10 minutes
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The duration of peak pressure
時間枠：During procedure, up to 10 minutes
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The duration of peak pressure will be collected.
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During procedure, up to 10 minutes
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Vessel Diameter
時間枠：During the procedure, up to 10 minutes
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Measurement of vessel diameter
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During the procedure, up to 10 minutes
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協力者と研究者
捜査官
- 主任研究者：Kyle M Fargen, MD, Ph.D、Wake Forest University Health Sciences
出版物と役立つリンク
一般刊行物
- S P Sutera a, Skalak R. The History of Poiseuille's Law. Annual Review of Fluid Mechanics. 1993;25(1):1-20
- Yousem DM, Trinh BC. Injection rates for neuroangiography: results of a survey. AJNR Am J Neuroradiol. 2001 Nov-Dec;22(10):1838-40.
- Hao Q, Lieber BB. Dispersive Transport of Angiographic Contrast During Antegrade Arterial Injection. Cardiovasc Eng Technol. 2012 Jun 1;3(2):171-178. doi: 10.1007/s13239-012-0090-x. Epub 2012 Apr 13.
- Alexander MD, Nicholson AD, Darflinger RJ, Settecase F, Cooke DL, Dowd CF, Amans MR, Higashida RT, Hetts SW, Halbach VV. Effects on vessel measurement accuracy and subsequent occlusion after calcium channel blocker infusion during treatment of cerebral aneurysms with the Pipeline embolization device. Interv Neuroradiol. 2017 Feb;23(1):47-51. doi: 10.1177/1591019916674916. Epub 2016 Oct 27.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- IRB00049517
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?
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
米国FDA規制機器製品の研究
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。
Standard of Care Cerebral Angiogram Groupの臨床試験
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Compedica IncProfessional Education and Research Institute募集
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DeRoyal Industries, Inc.Lincoln Memorial University完了皮膚感作 | 機械的、熱的、および放射線刺激に対する皮膚反応アメリカ
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University of PittsburghShadyside Hospital Foundation完了