Strain Analysis as a Right Ventricle Contractility Marker
2019年10月30日 更新者：Hospices Civils de Lyon
The analysis of the systolic function (contractility) of the right ventricle (RV) is fundamental and central in many pathologies in intensive care unit.
It can guide physicians in choosing therapeutics.
The conventional ultrasound markers of RV function evaluation currently used are influenced by RV loading conditions, impairing their capacity to approximate a true contractility analysis.
Myocardial strain imaging is a recent echographic technique that allows, among other things, to evaluate RV systolic function.
It is a reproducible index with early variations which, if it proved to be independent pre-load, would help to better appreciate the RV contractility.
調査の概要
研究の種類
介入
入学 (実際)
16
段階
- 適用できない
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。
研究場所
-
-
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Lyon、フランス、69004
- Hopital de la croix rousse
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Lyon、フランス、69007
- Hopital Saint Joseph Saint Luc
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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
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Male or female ≥ 18 years
- Patients with renal failure treated with intermittent hemodialysis
- Patients who received an information and did not opposed to participate in the study, or, if unconscious patient at the time of inclusion: a person of trust as defined in Article L. 1111-6 of the Public Health Code, failing that, the family or, failing that, a person maintaining stable link, having received information and not opposed to participate in the study.
Exclusion Criteria:
- Patients with heart disease (valvular, ischemic, rhythmic)
- Patients with ejection fraction of left ventricular altered <45%
- Chronic dialysis patients
Patients referred in Articles L. 1121-5, L.1121-6, L.1121-7, L.1121-8 of the Public Health Code:
- Pregnant women, parturients or nursing mothers
- Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care, persons admitted to a health or social institution for purposes other than research
- Minor Patients
- Major persons who are subject to a legal protection measure or are unable to express their consent
- Patients not willing to participate in the study
- Patients not affiliated to a social security
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
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：ultrasound measurements
ultrasound measurements of myocardial deformation of free wall right ventricle during a sharp decline of right ventricle preload induced during a session of Intermittent hemodialysis.
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ultrasound measurements of myocardial deformation of free wall right ventricle at 4 time points during a session of intermittent hemodialysis : before the intermittent hemodialysis connection, just after starting hemodialysis, after 1 hour of hemodialysis and 5 minutes before restitution
|
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 |
|---|---|---|
|
Evaluation of the change in the Longitudinal strain of the free wall right ventricle
時間枠：at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound
|
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Evaluation of the change in S' right ventricle wave
時間枠：at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound
|
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
|
Evaluation of the change in tricuspid annular plane systolic excursion (TAPSE)
時間枠：at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound
|
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
|
Evaluation of the change in visual left ventricular ejection fraction (LVEF)
時間枠：at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound
|
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
|
Evaluation of the change in mitral E wave
時間枠：at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound
|
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
|
Evaluation of the change in mitral A wave
時間枠：at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound
|
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
|
Evaluation of the change in wave E ' at the lateral mitral ring
時間枠：at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound
|
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
|
Evaluation of the change in systolic fraction of pulmonary venous flow
時間枠：at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound
|
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
|
inter individual variability of Longitudinal strain of the free wall right ventricle
時間枠：at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
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Each measurement will be performed by two blind operators
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at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
|
intra individual variability of Longitudinal strain of the free wall right ventricle
時間枠：at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
Each measurement will be performed by two blind operators
|
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
|
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：Zoé Schmitt、Hopital De La Croix-Rousse
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 (実際)
2016年11月25日
一次修了 (実際)
2017年12月31日
研究の完了 (実際)
2017年12月31日
試験登録日
最初に提出
2017年3月10日
QC基準を満たした最初の提出物
2017年3月20日
最初の投稿 (実際)
2017年3月24日
学習記録の更新
投稿された最後の更新 (実際)
2019年10月31日
QC基準を満たした最後の更新が送信されました
2019年10月30日
最終確認日
2019年10月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 69HCL16-0370
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
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