NCT04794192

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

2.6 years

First QC Date

March 5, 2021

Last Update Submit

March 6, 2023

Conditions

Arteriopathy

Outcome Measures

Primary Outcomes (1)

  • 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 (10)

  • Determination of the age of the population

    Day 1

  • Determination of the sex of the population

    Day 1

  • Number of participants with presence of hypertension

    Day 1

  • Number of smokers among the participants

    Day 1

  • Number of participants with cardiovascular history

    Day 1

  • +5 more secondary outcomes

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, Île-de-France Region, 75014, France

Location

Study Officials

  • Raphaël ATTAL

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2021

First Posted

March 11, 2021

Study Start

November 25, 2019

Primary Completion

June 30, 2022

Study Completion

April 30, 2023

Last Updated

March 7, 2023

Record last verified: 2023-03

Locations

FR(1)