NCT02037178

Screening for Arteriopathy in General Medicine: a Preliminary Feasibility Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 .

Conditions

• Peripheral Obliterative Arteriopathy

Interventions

Type	Name	Description
OTHER	First ultrasound reading	First ultrasound reading of the sub-renal abdominal aorta by a general practitioner.
OTHER	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.

Timeline

• Start date: 2014-10-28
• Primary completion: 2017-12-20
• Completion: 2017-12-20
• First posted: 2014-01-15
• Last updated: 2018-01-03

Locations

2 sites across 1 country: France