Assessment of the Ankle Systolic Pressure Index in Patients Over 70 Years of Age With Jaundice Ulcer
- Conditions
- Arteriopathy
- Registration Number
- NCT04794192
- Lead Sponsor
- Fondation Hôpital Saint-Joseph
- Brief Summary
Arteriopathy of the lower limbs (ALL) is defined by a decreased ankle perfusion pressure with a systolic pressure index (SPI) \<0.9, and constitutes the most advanced situation in terms of cardiovascular prognosis with in 20 % of cases of lesions associated with the heart and / or coronary heart. The severity of ALL is linked to the risk of a cardiovascular event, hence the need for a hemodynamic evaluation which is mainly based on the measurement of SPI.
- Detailed Description
However, the presence of mediacalcosis, making the arteries incompressible, limits the interpretation of IPS. However, ALL affects 50% of diabetic patients after 20 years of disease with predominant involvement in the infra-popliteal gland consisting mainly of mediacalcosis, but often respecting the arteries of the foot.
The recommendations of the French-speaking Association for the Study of Diabetes and Metabolic Diseases in 1997 and of the American Diabetes Association in 2001, recommended the SPI and the realization of ultrasound for the diagnosis of ALL. Some authors have shown that SPI can be falsely normal with 4.3 times more false negative ankle SPI in diabetics compared to the general population. This is why this measurement of the SPI is coupled with the measurement of the pressure of the big toe (PGT) or even the transcutaneous measurement of the oxygen pressure (TcPO2) as recommended by the American Heart Association (AHA) and the American College of Cardiology (ACC) in 2005, in case of uninterpretable IPS.
The subjects at risk of mediacalcosis are: diabetics, renal insufficiency and the very elderly.
A recent thesis work confirmed that the SPI alone was not reliable as a screening tool in diabetic patients, with good sensitivity of the measurement of PGT.
What about a population over the age of 70, without diabetes and without kidney failure?
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 53
- Man or woman aged> 70 hospitalized in the vascular medicine department of the Paris Saint-Joseph Hospital Group
- French-speaking patient
- Patient with treated or untreated diabetes
- Renal failure (GFR CKD-EPI or MDRD <60ml / min)
- ATCD revascularization or amputation
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient objecting to participation in the study
- Patient under legal protection.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the diagnostic performance of toe IPSI by laser-doppler, as a screening test for ALL in patients over 70 years of age, non-diabetic and non-renal failure, compared to the data of the considered Doppler ultrasound as the gold standard Day 1 Sensitivity and specificity of laser-doppler toe PSI for screening ALL in patients over 70 years of age.
- Secondary Outcome Measures
Name Time Method Number of participants with presence of hypertension Day 1 Presence of hypertension
Number of smokers among the participants Day 1 Tobacco
Relationship between ankle SPI and lower limb arterial disease risk factors Day 1 SPI ankle values by subgroups of risk factors for arterial disease of the lower limbs
Determination of the sex of the population Day 1 Sex
Number of participants with treatments Day 1 Treatments
Determination of the age of the population Day 1 Age
Search for predictive factors associated with ankle SPI for the diagnosis of arteriopathy of the lower limbs Day 1 Predictors associated with ankle PSI for the occurrence of lower limb arterial disease
Number of participants with cardiovascular history Day 1 Cardiovascular history
Relationship between toe SPI and risk factors for arterial disease of the lower limbs Day 1 SPI toe values by subgroups of risk factors for arterial disease of the lower limbs
Search for predictive factors associated with toe SPI for the diagnosis of arteriopathy of the lower limbs Day 1 Predictors associated with toe PSI for the occurrence of lower limb arterial disease
Trial Locations
- Locations (1)
Groupe Hospitalier Paris Saint-Joseph
🇫🇷Paris, Ile De France, France