Screening for Arteriopathy in General Medicine: a Preliminary Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Largest external antero-posterior diameter of the sub-renal abdominal aorta (mm)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Largest external antero-posterior diameter of the sub-renal abdominal aorta (mm)
时间窗: Baseline (day 0)
Measures made using both cross-sectional and longitudinal ultrasounds.
次要结局
- Largest external antero-posterior diameter of the sub-renal abdominal aorta (mm) : second interpretation of echographic material by a second expert(maximum of three months)
- SPI at the toe (mmHg)(baseline (Day 0))
- Ultrasound quality as assessed by the second expert(maximum of three months)