ArteriopathyIPSchevilleNCT04794192
Assessment of the Ankle Systolic Pressure Index in Patients Over 70 Years of Age With Jaundice Ulcer
An observational study of Arteriopathy, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Arteriopathy
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2019to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged> 70 hospitalized in the vascular medicine department of the Paris Saint-Joseph Hospital Group
Who may be able to join
- Man or woman aged> 70 hospitalized in the vascular medicine department of the Paris Saint-Joseph Hospital Group
- French-speaking patient
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint-Joseph
Paris, Île-de-France Region, 75014
About this study
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.
Read the 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?
- Conditions
- Arteriopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (10)
Determination of the age of the population
Age
Measured: Day 1
Determination of the sex of the population
Sex
Measured: Day 1
Number of participants with presence of hypertension
Presence of hypertension
Measured: Day 1
Number of smokers among the participants
Tobacco
Measured: Day 1
Number of participants with cardiovascular history
Cardiovascular history
Measured: Day 1
Number of participants with treatments
Treatments
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start25 Nov 2019
- Primary completion30 Jun 2022
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArteriopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raphaël ATTAL, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794192
- Sponsor's protocol ID
- IPS cheville
- Acronym
- IPScheville
- Status last verified
- Mar 2023
- First submitted
- 5 Mar 2021
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Ankle Systolic Pressure Index in Patients Over 70 Years of Age With Jaundice Ulcer
- ClinicalTrials.gov ID
- NCT04794192
- Acronym / sponsor ID
- IPScheville / IPS cheville
- Conditions
- Arteriopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged> 70 hospitalized in the vascular medicine department of the Paris Saint-Joseph Hospital Group
Key inclusion criteria (2 listed)
- Man or woman aged> 70 hospitalized in the vascular medicine department of the Paris Saint-Joseph Hospital Group
- French-speaking patient
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: Day 1
Sensitivity and specificity of laser-doppler toe PSI for screening ALL in patients over 70 years of age.
10 secondary outcomes
Determination of the age of the population
Time frame: Day 1
Determination of the sex of the population
Time frame: Day 1
Number of participants with presence of hypertension
Time frame: Day 1
Number of smokers among the participants
Time frame: Day 1
Number of participants with cardiovascular history
Time frame: Day 1
Number of participants with treatments
Time frame: Day 1
Relationship between toe SPI and risk factors for arterial disease of the lower limbs
Time frame: Day 1
Relationship between ankle SPI and lower limb arterial disease risk factors
Time frame: Day 1
Search for predictive factors associated with toe SPI for the diagnosis of arteriopathy of the lower limbs
Time frame: Day 1
Search for predictive factors associated with ankle SPI for the diagnosis of arteriopathy of the lower limbs
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
Related trials for Arteriopathy
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphaël ATTAL principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arteriopathy, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.