Clinical trial NCT02037178: Screening for Arteriopathy in General Medicine: a Preliminary Feasibility Study
Official title: Screening for Arteriopathy in General Medicine: a Preliminary Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Obliterative Arteriopathy
Keywords: Peripheral Obliterative Arteriopathy of the legs
Screening by generalists
Ultrasound
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2014-01-15
Enrollment: 300
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief 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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Largest external antero-posterior diameter of the sub-renal abdominal aorta (mm)
timeFrame: Baseline (day 0)
Secondary outcomes:
measure: SPI at the toe (mmHg)
timeFrame: baseline (Day 0)
measure: Largest external antero-posterior diameter of the sub-renal abdominal aorta (mm) : second interpretation of echographic material by a second expert
timeFrame: maximum of three months
measure: Ultrasound quality as assessed by the second expert
timeFrame: maximum of three months
Other outcomes:
measure: Age
timeFrame: baseline (day 0)
measure: Smoker? yes/no
timeFrame: baseline (day 0)
measure: Hypertension? yes/no
timeFrame: baseline (day 0)
Locations:
city: Nîmes cedex 2
country: France
facility: Centre Médico Sportif
city: Nîmes Cedex 9
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: David Costa, MD
role: PRINCIPAL_INVESTIGATOR
References: