Screening for Arteriopathy in General Medicine: a Preliminary Feasibility Study

Peripheral Obliterative Arteriopathy Clinical Trial

— DAG  

Official title:

Screening for Arteriopathy in General Medicine: a Preliminary Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02037178
• Other study ID #: LOCAL/2013/JLLD-01
• Secondary ID: 2013-A01583-42
• Status: Completed
• Phase: N/A
• First received: January 14, 2014
• Last updated: January 2, 2018
• Start date: October 28, 2014
• Est. completion date: December 20, 2017

Study information

• Verified date: January 2018
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 20, 2017
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Obliterative Arteriopathy

Intervention

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

Locations

Country	Name	City	State
France	Centre Médico Sportif	Nîmes cedex 2
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age		baseline (day 0)
Other	Smoker? yes/no		baseline (day 0)
Other	Hypertension? yes/no		baseline (day 0)
Primary	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	SPI at the toe (mmHg)		baseline (Day 0)
Secondary	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
Secondary	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