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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Obliterative Arteriopathy
• Intervention / Treatment: Other: First ultrasound reading; Other: Second ultrasound interpretation

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 .

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
The study population; See inclusion/exclusion criteria. Intervention: First ultrasound reading Intervention: Second ultrasound interpretation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Largest external antero-posterior diameter of the sub-renal abdominal aorta (mm)	Measures made using both cross-sectional and longitudinal ultrasounds.	Baseline (day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SPI at the toe (mmHg)		baseline (Day 0)
Largest external antero-posterior diameter of the sub-renal abdominal aorta (mm) : second interpretation of echographic material by a second expert	Measures made using both cross-sectional and longitudinal ultrasounds.	maximum of three months
Ultrasound quality as assessed by the second expert	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	maximum of three months

Other Outcome Measures

Outcome Measure	Time Frame
Age	baseline (day 0)
Smoker? yes/no	baseline (day 0)
Hypertension? yes/no	baseline (day 0)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2014
• Primary Completion (Actual): December 20, 2017
• Study Completion (Actual): December 20, 2017

Study Registration Dates

• First Submitted: January 14, 2014
• First Submitted That Met QC Criteria: January 14, 2014
• First Posted (Estimate): January 15, 2014

Study Record Updates

• Last Update Posted (Actual): January 3, 2018
• Last Update Submitted That Met QC Criteria: January 2, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Ultrasound; Peripheral Obliterative Arteriopathy of the legs; Screening by generalists
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: LOCAL/2013/JLLD-01; 2013-A01583-42 (Other Identifier: RCB number)