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Screening for Arteriopathy in General Medicine: a Preliminary Feasibility Study (DAG)

2018年1月2日 更新者：Centre Hospitalier Universitaire de Nīmes
The main objective of this study is to evaluate the inter-observer concordance when measuring the maximum value of the external antero-posterior diameter of the sub-renal aorta (both cross-sectional and longitudinal ultrasound views are measured). The first measure is made by a general practitioner in private practice; second reading are made by an expert in vascular medicine.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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:

  1. appropriate image was not obtained or not recognized expert - uninterpretable
  2. poor image quality - interpretable
  3. 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 .

研究类型

观察性的

注册 (实际的)

300

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 法国
      • Nîmes Cedex 9、法国、30029
        • CHRU de Nîmes - Hôpital Universitaire Carémeau
      • Nîmes cedex 2、法国、30908
        • Centre Médico Sportif

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The study populations consists of men and women consulting with general practitioners and who are at high risk for cardio vascular disease a defined by the French Society of Vascular Medecin.

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
The study population

See inclusion/exclusion criteria.

Intervention: First ultrasound reading

Intervention: Second ultrasound interpretation
其他：First ultrasound reading
First ultrasound reading of the sub-renal abdominal aorta by a general practitioner.
其他：Second ultrasound interpretation
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Largest external antero-posterior diameter of the sub-renal abdominal aorta (mm)
大体时间：Baseline (day 0)
Measures made using both cross-sectional and longitudinal ultrasounds.
Baseline (day 0)

次要结果测量

结果测量
措施说明
大体时间
SPI at the toe (mmHg)
大体时间：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
大体时间：maximum of three months
Measures made using both cross-sectional and longitudinal ultrasounds.
maximum of three months
Ultrasound quality as assessed by the second expert
大体时间：maximum of three months

This evaluation with use a 3-level scale:

  1. appropriate image was not obtained or not recognized expert - uninterpretable
  2. poor image quality - interpretable
  3. image of good or very good quality - interpretable
maximum of three months

其他结果措施

结果测量
大体时间
年龄
大体时间：基线（第 0 天）
基线（第 0 天）
Smoker? yes/no
大体时间：baseline (day 0)
baseline (day 0)
Hypertension? yes/no
大体时间：baseline (day 0)
baseline (day 0)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Centre Hospitalier Universitaire de Nīmes

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2014年10月28日

初级完成 (实际的)

2017年12月20日

研究完成 (实际的)

2017年12月20日

研究注册日期

首次提交

2014年1月14日

首先提交符合 QC 标准的

2014年1月14日

首次发布 (估计)

2014年1月15日

研究记录更新

最后更新发布 (实际的)

2018年1月3日

上次提交的符合 QC 标准的更新

2018年1月2日

最后验证

2018年1月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • LOCAL/2013/JLLD-01
  • 2013-A01583-42 (其他标识符：RCB number)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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