Peripheral Obliterative ArteriopathyDAGNCT02037178
Screening for Arteriopathy in General Medicine: a Preliminary Feasibility Study
An observational study of Peripheral Obliterative Arteriopathy, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
The main objective of this study is to evaluate the inter-observer concordance when measuring the maximum value of the external antero-posterior diameter of the sub-renal aorta (both cross-sectional and longitudinal ultrasound views are measured). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Peripheral Obliterative Arteriopathy
- What is being tested?
- First ultrasound reading and Second ultrasound interpretation
- How many people
- 300 participants
- Where
- 2 sitesFrance
- Study dates
- 28 Oct 2014to 20 Dec 2017
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study populations consists of men and women consulting with general practitioners and who are at high risk for cardio vascular disease a defined by the French Society of Vascular Medecin.
Who may be able to join
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient falls into one of the following 4 groups as defined by the French Society of Vascular Medecin (2006):
- (1) Men and women 60-75 years of age who are active smokers or ex-smokers
- (2) Men over 75 years of age
- (3) Women over 75 years of age who smoke and who have known hypertension
- (4) Men and women over 50 years of age with a family history of aneurysm of the abdominal aorta
Who cannot join
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The subject has an allergy to the gel used for ultrasound examination.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
Centre Médico Sportif
Nîmes, 30908
About this study
The main objective of this study is to evaluate the inter-observer concordance when measuring the maximum value of the external antero-posterior diameter of the sub-renal aorta (both cross-sectional and longitudinal ultrasound views are measured). The first measure is made by a general practitioner in private practice; second reading are made by an expert in vascular medicine.
Read the detailed description
The secondary objectives of this study are:
- To assess the prevalence of Abdominal Aortic Aneurysm (AAA) detected by ultrasound measurement of the anterior and posterior longitudinal outer diameter of the sub-renal abdominal aorta in a high cardiovascular risk population consulting with general practitioners (defined according to recommendations stated by the French Society of Vascular Medicine).
- To assess the prevalence of Peripheral Obliterative Arteriopathy of the Legs (POAL) by measuring the Systolic Pressure Index (SPI) at the toe (ratio of arterial pressure in upper limbs versus lower limbs). Measures are made by a general practitioner in the same population.
- To assess the quality and interpretability of ultrasound recordings and ultrasound acquistion failure rate. These second measures are made by an expert in vascular medecine. This evaluation with use a 3-level scale:
- appropriate image was not obtained or not recognized expert - uninterpretable
- poor image quality - interpretable
- image of good or very good quality - interpretable
- To calculate the impact of risk cofactors such as hypertension , smoking, age and family history among patients diagnosed with AAA.
- Evaluation of general practitioner training from a qualitative and quantitative point of view after 4 h of training organized by Dr. Bobbià .
- Conditions
- Peripheral Obliterative Arteriopathy
- Being tested
- First ultrasound reading, Second ultrasound interpretation
- Keywords
- Peripheral Obliterative Arteriopathy of the legs, Screening by generalists, Ultrasound
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First ultrasound readingOther
First ultrasound reading of the sub-renal abdominal aorta by a general practitioner.
Second ultrasound interpretationOther
The untrasound images recorded by general practitioners will be interpreted a second time by an expert in vascular medecine, and evaluated for their image quality.
| Study group | Role | What they receive |
|---|---|---|
| The study population | See inclusion/exclusion criteria.
Intervention: First ultrasound reading
Intervention: Second ultrasound interpretation Receives: Other: First ultrasound reading; Other: Second ultrasound interpretation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Largest external antero-posterior diameter of the sub-renal abdominal aorta (mm)
Measures made using both cross-sectional and longitudinal ultrasounds.
Measured: Baseline (day 0)
Secondary outcomes (3)
SPI at the toe (mmHg)
Measured: baseline (Day 0)
Largest external antero-posterior diameter of the sub-renal abdominal aorta (mm) : second interpretation of echographic material by a second expert
Measures made using both cross-sectional and longitudinal ultrasounds.
Measured: maximum of three months
Ultrasound quality as assessed by the second expert
This evaluation with use a 3-level scale:
- appropriate image was not obtained or not recognized expert - uninterpretable
- poor image quality - interpretable
- image of good or very good quality - interpretable
Measured: maximum of three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study start28 Oct 2014
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Obliterative ArteriopathyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Costa, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037178
- Sponsor's protocol ID
- LOCAL/2013/JLLD-01
- Other IDs
- 2013-A01583-42
- Acronym
- DAG
- Status last verified
- Jan 2018
- First submitted
- 14 Jan 2014
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Arteriopathy in General Medicine: a Preliminary Feasibility Study
- ClinicalTrials.gov ID
- NCT02037178
- Acronym / sponsor ID
- DAG / LOCAL/2013/JLLD-01
- Conditions
- Peripheral Obliterative Arteriopathy
- Keywords
- Peripheral Obliterative Arteriopathy of the legs, Screening by generalists, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 28 Oct 2014 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 15 Jan 2014 (estimated)
- 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.
The main objective of this study is to evaluate the inter-observer concordance when measuring the maximum value of the external antero-posterior diameter of the sub-renal aorta (both cross-sectional and longitudinal ultrasound views are measured). The first measure is made by a general practitioner in private practice; second reading are made by an expert in vascular medicine.
Detailed description
The secondary objectives of this study are:
- To assess the prevalence of Abdominal Aortic Aneurysm (AAA) detected by ultrasound measurement of the anterior and posterior longitudinal outer diameter of the sub-renal abdominal aorta in a high cardiovascular risk population consulting with general practitioners (defined according to recommendations stated by the French Society of Vascular Medicine).
- To assess the prevalence of Peripheral Obliterative Arteriopathy of the Legs (POAL) by measuring the Systolic Pressure Index (SPI) at the toe (ratio of arterial pressure in upper limbs versus lower limbs). Measures are made by a general practitioner in the same population.
- To assess the quality and interpretability of ultrasound recordings and ultrasound acquistion failure rate. These second measures are made by an expert in vascular medecine. This evaluation with use a 3-level scale:
- appropriate image was not obtained or not recognized expert - uninterpretable
- poor image quality - interpretable
- image of good or very good quality - interpretable
- To calculate the impact of risk cofactors such as hypertension , smoking, age and family history among patients diagnosed with AAA.
- Evaluation of general practitioner training from a qualitative and quantitative point of view after 4 h of training organized by Dr. Bobbià .
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | Other: First ultrasound reading, Other: Second ultrasound interpretationSee inclusion/exclusion criteria. Intervention: First ultrasound reading Intervention: Second ultrasound interpretation |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study populations consists of men and women consulting with general practitioners and who are at high risk for cardio vascular disease a defined by the French Society of Vascular Medecin.
Key inclusion criteria (7 listed)
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient falls into one of the following 4 groups as defined by the French Society of Vascular Medecin (2006):
- (1) Men and women 60-75 years of age who are active smokers or ex-smokers
- (2) Men over 75 years of age
Key exclusion criteria (5 listed)
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The subject has an allergy to the gel used for ultrasound examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| First ultrasound readingFirst ultrasound reading of the sub-renal abdominal aorta by a general practitioner. | Other | The study population |
| Second ultrasound interpretationThe untrasound images recorded by general practitioners will be interpreted a second time by an expert in vascular medecine, and evaluated for their image quality. | Other | The study population |
Primary outcome
Largest external antero-posterior diameter of the sub-renal abdominal aorta (mm)
Time frame: Baseline (day 0)
Measures made using both cross-sectional and longitudinal ultrasounds.
3 secondary outcomes
SPI at the toe (mmHg)
Time frame: baseline (Day 0)
Largest external antero-posterior diameter of the sub-renal abdominal aorta (mm) : second interpretation of echographic material by a second expert
Time frame: maximum of three months
Ultrasound quality as assessed by the second expert
Time frame: maximum of three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
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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.
David Costa, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Obliterative Arteriopathy, run by Centre Hospitalier Universitaire de Nīmes at 2 sites 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Largest external antero-posterior diameter of the sub-renal abdominal aorta (mm) (time frame: Baseline (day 0)). 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 3 Jan 2018.