Screening for Arteriopathy in General Medicine: a Preliminary Feasibility Study (DAG)
調査の概要
状態
詳細な説明
The secondary objectives of this study are:
A. To assess the prevalence of Abdominal Aortic Aneurysm (AAA) detected by ultrasound measurement of the anterior and posterior longitudinal outer diameter of the sub-renal abdominal aorta in a high cardiovascular risk population consulting with general practitioners (defined according to recommendations stated by the French Society of Vascular Medicine).
B. To assess the prevalence of Peripheral Obliterative Arteriopathy of the Legs (POAL) by measuring the Systolic Pressure Index (SPI) at the toe (ratio of arterial pressure in upper limbs versus lower limbs). Measures are made by a general practitioner in the same population.
C. To assess the quality and interpretability of ultrasound recordings and ultrasound acquistion failure rate. These second measures are made by an expert in vascular medecine. This evaluation with use a 3-level scale:
- appropriate image was not obtained or not recognized expert - uninterpretable
- poor image quality - interpretable
- image of good or very good quality - interpretable
D. To calculate the impact of risk cofactors such as hypertension , smoking, age and family history among patients diagnosed with AAA.
E. Evaluation of general practitioner training from a qualitative and quantitative point of view after 4 h of training organized by Dr. Bobbià .
研究の種類
入学 (実際)
連絡先と場所
研究場所
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-
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Nîmes Cedex 9、フランス、30029
- CHRU de Nîmes - Hôpital Universitaire Carémeau
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Nîmes cedex 2、フランス、30908
- Centre Médico Sportif
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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
説明
Inclusion Criteria:
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient falls into one of the following 4 groups as defined by the French Society of Vascular Medecin (2006):
- (1) Men and women 60-75 years of age who are active smokers or ex-smokers
- (2) Men over 75 years of age
- (3) Women over 75 years of age who smoke and who have known hypertension
- (4) Men and women over 50 years of age with a family history of aneurysm of the abdominal aorta
Exclusion Criteria:
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The subject has an allergy to the gel used for ultrasound examination.
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 |
|---|---|
|
The study population
See inclusion/exclusion criteria. Intervention: First ultrasound reading Intervention: Second ultrasound interpretation |
First ultrasound reading of the sub-renal abdominal aorta by a general practitioner.
The untrasound images recorded by general practitioners will be interpreted a second time by an expert in vascular medecine, and evaluated for their image quality.
|
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 |
|---|---|---|
|
Largest external antero-posterior diameter of the sub-renal abdominal aorta (mm)
時間枠：Baseline (day 0)
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Measures made using both cross-sectional and longitudinal ultrasounds.
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Baseline (day 0)
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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 |
|---|---|---|
|
SPI at the toe (mmHg)
時間枠：baseline (Day 0)
|
baseline (Day 0)
|
|
|
Largest external antero-posterior diameter of the sub-renal abdominal aorta (mm) : second interpretation of echographic material by a second expert
時間枠：maximum of three months
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Measures made using both cross-sectional and longitudinal ultrasounds.
|
maximum of three months
|
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Ultrasound quality as assessed by the second expert
時間枠：maximum of three months
|
This evaluation with use a 3-level scale:
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maximum of three months
|
その他の成果指標
結果測定 |
時間枠 |
|---|---|
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年
時間枠：ベースライン (0日目)
|
ベースライン (0日目)
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Smoker? yes/no
時間枠：baseline (day 0)
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baseline (day 0)
|
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Hypertension? yes/no
時間枠：baseline (day 0)
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baseline (day 0)
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協力者と研究者
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 (見積もり)
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
- LOCAL/2013/JLLD-01
- 2013-A01583-42 (その他の識別子：RCB number)
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