Assessment of the Ankle Systolic Pressure Index in Patien... | NCT04794192

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

NCT04794192

Sponsor

Fondation Hôpital Saint-Joseph

Status

Unknown status

Last Update Posted

Mar 7, 2023Actual

Enrollment

53Actual

Phase

Not provided

Conditions

Arteriopathy

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 25, 2019Actual

Primary Completion Date

Jun 30, 2022Actual

Completion Date

Apr 30, 2023Estimated

First Submitted Date

Mar 5, 2021

First Submission Date that Met QC Criteria

Mar 9, 2021

First Posted Date

Mar 11, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2023

Last Update Posted Date

Mar 7, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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?

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Determination of the age of the population	Age	Day 1
Determination of the sex of the population	Sex	Day 1

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Raphaël ATTAL	Fondation Hôpital Saint-Joseph	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groupe Hospitalier Paris Saint-Joseph		Paris	Île-de-France Region	75014	France