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

Arteriopathy Clinical Trial

— IPScheville  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04794192
• Other study ID #: IPS cheville
• Status: Active, not recruiting
• Start date: November 25, 2019
• Est. completion date: April 30, 2023

Study information

• Verified date: March 2023
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 53
• Est. completion date: April 30, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteriopathy
• Jaundice

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint-Joseph	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determination of the age of the population	Age	Day 1
Secondary	Determination of the sex of the population	Sex	Day 1
Secondary	Number of participants with presence of hypertension	Presence of hypertension	Day 1
Secondary	Number of smokers among the participants	Tobacco	Day 1
Secondary	Number of participants with cardiovascular history	Cardiovascular history	Day 1
Secondary	Number of participants with treatments	Treatments	Day 1
Secondary	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
Secondary	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
Secondary	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
Secondary	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