Clinical trial NCT04794192: Assessment of the Ankle Systolic Pressure Index in Patients Over 70 Years of Age With Jaundice Ulcer
Official title: Assessment of the Ankle Systolic Pressure Index in Patients Over 70 Years of Age With Jaundice Ulcer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arteriopathy
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 53
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged\> 70 hospitalized in the vascular medicine department of the Paris Saint-Joseph Hospital Group

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?

Eligibility criteria: Inclusion Criteria:

* Man or woman aged\> 70 hospitalized in the vascular medicine department of the Paris Saint-Joseph Hospital Group
* French-speaking patient

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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
timeFrame: Day 1
Secondary outcomes:
measure: Determination of the age of the population
timeFrame: Day 1
measure: Determination of the sex of the population
timeFrame: Day 1
measure: Number of participants with presence of hypertension
timeFrame: Day 1
measure: Number of smokers among the participants
timeFrame: Day 1
measure: Number of participants with cardiovascular history
timeFrame: Day 1
measure: Number of participants with treatments
timeFrame: Day 1
measure: Relationship between toe SPI and risk factors for arterial disease of the lower limbs
timeFrame: Day 1
measure: Relationship between ankle SPI and lower limb arterial disease risk factors
timeFrame: Day 1
measure: Search for predictive factors associated with toe SPI for the diagnosis of arteriopathy of the lower limbs
timeFrame: Day 1
measure: Search for predictive factors associated with ankle SPI for the diagnosis of arteriopathy of the lower limbs
timeFrame: Day 1
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
state: Ile De France
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Raphaël ATTAL
role: PRINCIPAL_INVESTIGATOR
References: