Assessment of the Ankle Systolic Pressure Index in Patients Over 70 Years of Age With Jaundice Ulcer (IPScheville)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Arteriopathy

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?

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75014
      • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients aged> 70 hospitalized in the vascular medicine department of the Paris Saint-Joseph Hospital Group

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Sensitivity and specificity of laser-doppler toe PSI for screening ALL in patients over 70 years of age.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of the age of the population	Age	Day 1
Determination of the sex of the population	Sex	Day 1
Number of participants with presence of hypertension	Presence of hypertension	Day 1
Number of smokers among the participants	Tobacco	Day 1
Number of participants with cardiovascular history	Cardiovascular history	Day 1
Number of participants with treatments	Treatments	Day 1
Relationship between toe SPI and risk factors for arterial disease of the lower limbs	SPI toe values by subgroups of risk factors for arterial disease of the lower limbs	Day 1
Relationship between ankle SPI and lower limb arterial disease risk factors	SPI ankle values by subgroups of risk factors for arterial disease of the lower limbs	Day 1
Search for predictive factors associated with toe SPI for the diagnosis of arteriopathy of the lower limbs	Predictors associated with toe PSI for the occurrence of lower limb arterial disease	Day 1
Search for predictive factors associated with ankle SPI for the diagnosis of arteriopathy of the lower limbs	Predictors associated with ankle PSI for the occurrence of lower limb arterial disease	Day 1

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph
• Investigators: Principal Investigator: Raphaël ATTAL, Groupe hospitalier Paris saint Joseph

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2019
• Primary Completion (Actual): June 30, 2022
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Manifestations; Hyperbilirubinemia; Jaundice
• Other Study ID Numbers: IPS cheville

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No