Screening for Arteriopathy in General Medicine: a Preliminary Feasibility Study (DAG)
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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 .
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Nîmes Cedex 9, Frankrike, 30029
- CHRU de Nîmes - Hôpital Universitaire Carémeau
-
Nîmes cedex 2, Frankrike, 30908
- Centre Médico Sportif
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
The study population
See inclusion/exclusion criteria. Intervention: First ultrasound reading Intervention: Second ultrasound interpretation |
First ultrasound reading of the sub-renal abdominal aorta by a general practitioner.
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Largest external antero-posterior diameter of the sub-renal abdominal aorta (mm)
Tidsramme: Baseline (day 0)
|
Measures made using both cross-sectional and longitudinal ultrasounds.
|
Baseline (day 0)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
SPI at the toe (mmHg)
Tidsramme: baseline (Day 0)
|
baseline (Day 0)
|
|
|
Largest external antero-posterior diameter of the sub-renal abdominal aorta (mm) : second interpretation of echographic material by a second expert
Tidsramme: maximum of three months
|
Measures made using both cross-sectional and longitudinal ultrasounds.
|
maximum of three months
|
|
Ultrasound quality as assessed by the second expert
Tidsramme: maximum of three months
|
This evaluation with use a 3-level scale:
|
maximum of three months
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Alder
Tidsramme: grunnlinje (dag 0)
|
grunnlinje (dag 0)
|
|
Smoker? yes/no
Tidsramme: baseline (day 0)
|
baseline (day 0)
|
|
Hypertension? yes/no
Tidsramme: baseline (day 0)
|
baseline (day 0)
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LOCAL/2013/JLLD-01
- 2013-A01583-42 (Annen identifikator: RCB number)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .