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Completed

NCT Number: NCT02037178

Screening for Arteriopathy in General Medicine: a Preliminary Feasibility Study

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Nîmes - Hôpital Universitaire Carémeau, Nîmes, France

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About this study

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

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

First ultrasound reading

Other

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

Second ultrasound interpretation

Other

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.

Primary outcomes

  1. Largest external antero-posterior diameter of the sub-renal abdominal aorta (mm)

    Time frame: Baseline (day 0)

    Measures made using both cross-sectional and longitudinal ultrasounds.

Secondary outcomes

  1. SPI at the toe (mmHg)

    Time frame: baseline (Day 0)

  2. Largest external antero-posterior diameter of the sub-renal abdominal aorta (mm) : second interpretation of echographic material by a second expert

    Time frame: maximum of three months

    Measures made using both cross-sectional and longitudinal ultrasounds.

  3. Ultrasound quality as assessed by the second expert

    Time frame: maximum of three months

    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

Other outcomes

  1. Age

    Time frame: baseline (day 0)

  2. Smoker? yes/no

    Time frame: baseline (day 0)

  3. Hypertension? yes/no

    Time frame: baseline (day 0)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: DAG

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 15, 2014
Registry last updated
Jan 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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