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Screening for Arteriopathy in General Medicine: a Preliminary Feasibility Study

Screening for Arteriopathy in General Medicine: a Preliminary Feasibility Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02037178
Acronym
DAG
Enrollment
300
Registered
2014-01-15
Start date
2014-10-28
Completion date
2017-12-20
Last updated
2018-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Obliterative Arteriopathy

Keywords

Peripheral Obliterative Arteriopathy of the legs, Screening by generalists, Ultrasound

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 .

Interventions

OTHERFirst ultrasound reading

First ultrasound reading of the sub-renal abdominal aorta by a general practitioner.

OTHERSecond 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.

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
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 expertmaximum of three monthsMeasures made using both cross-sectional and longitudinal ultrasounds.
Ultrasound quality as assessed by the second expertmaximum of three monthsThis 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

Other

MeasureTime frame
Hypertension? yes/nobaseline (day 0)
Agebaseline (day 0)
Smoker? yes/nobaseline (day 0)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026