Carotid AtherosclerosisPROCAVE-DNCT02929355
Carotid Atherosclerosis and Vascular Events in People With Diabetes
An observational study of Carotid Atherosclerosis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Diabetes is a risk factor for carotid atherosclerotic whose progression is associated with an increased risk of vascular events. Investigators assessed prospectively by arterial duplex ultrasonography the progression of carotid atherosclerosis in a cohort of people with diabetes to assess the importance of progression… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Atherosclerosis
- What is being tested?
- carotid assesment by duplex ultrasonography
- How many people
- 731 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Sep 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diabetes and a carotid assessment by duplex ultrasonography in 2012 in a monocentric diabetic unit
Who may be able to join
- Age >18 ans
- Diabetes
- Carotid duplex ultrasonography in 2012
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Endocrinologie, Diabète et Maladie de la Nutrition, GH Sud, Hospices Civils de Lyon
Pierre-Bénite, 69310
About this study
Official title: Progression of Carotid Atherosclerosis and Vascular Events in People With Diabetes: A Prospective Cohort Study
Diabetes is a risk factor for carotid atherosclerotic whose progression is associated with an increased risk of vascular events. Investigators assessed prospectively by arterial duplex ultrasonography the progression of carotid atherosclerosis in a cohort of people with diabetes to assess the importance of progression and to analyze the impact of this progression on vascular events. The main hypothesis is that people with carotid atherosclerosis progression are at higher risk of vascular events than those without any progression.
- Conditions
- Carotid Atherosclerosis
- Being tested
- carotid assesment by duplex ultrasonography
- Keywords
- Carotid atherosclerosis, duplex ultrasonography, diabetes, vascular events
- Medical subject headings
- Carotid Artery Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carotid assesment by duplex ultrasonographyOther
| Study group | Role | What they receive |
|---|---|---|
| diabetic patients with carotid assessment | Patients with diabetes and a carotid assessment by duplex ultrasonography in 2012 in a monocentric diabetic unit Receives: Other: carotid assesment by duplex ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of vascular events between day one and the last day of follow-up reviewed by patient examination
Vascular events include ischemic myocardial events, ischemic cerebrovascular events, lower limb ischemia, arterial revascularization procedure
Measured: Day of the last assessment of carotid atherosclerosis by duplex ultrasonography (between 01/2014 and 09/2016)
Secondary outcomes (1)
Rate of carotid atherosclerosis progression measured by duplex ultrasonography in percentage of stenosis
At each visit, carotid arteries were examined by duplex ultrasonography. The most severe lesion for each patient was selected. Results were classified in three Strandness categories: normal (no atherosclerotic lesions), stenosis < 50% (systolic ratio Internal Carotid Artery (ICA)/Common Carotid Artery (CCA) < 2) and stenosis ≥ 50% (systolic ratio ICA/CCA ≥ 2). A progression was the move to a higher category.
Measured: Day of the last assessment of carotid atherosclerosis by duplex ultrasonography between 01/2014 and 09/2016.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startJan 2012
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Prospective
- Enrolment
- 731 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929355
- Sponsor's protocol ID
- 69HCL16_0596
- Acronym
- PROCAVE-D
- Status last verified
- Sep 2016
- First submitted
- 23 Sep 2016
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Vouillarmet J, Marsot C, Maucort-Boulch D, Riche B, Helfre M, Grange C. Vascular Events and Carotid Atherosclerosis: A 5-Year Prospective Cohort Study in Patients with Type 2 Diabetes and a Contemporary Cardiovascular Prevention Treatment. J Diabetes Res. 2019 Dec 22;2019:9059761. doi: 10.1155/2019/9059761. eCollection 2019.
PubMed 31934592
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progression of Carotid Atherosclerosis and Vascular Events in People With Diabetes: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02929355
- Acronym / sponsor ID
- PROCAVE-D / 69HCL16_0596
- Conditions
- Carotid Atherosclerosis
- Keywords
- Carotid atherosclerosis, duplex ultrasonography, diabetes, vascular events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 731 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 11 Oct 2016 (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.
Diabetes is a risk factor for carotid atherosclerotic whose progression is associated with an increased risk of vascular events. Investigators assessed prospectively by arterial duplex ultrasonography the progression of carotid atherosclerosis in a cohort of people with diabetes to assess the importance of progression and to analyze the impact of this progression on vascular events. The main hypothesis is that people with carotid atherosclerosis progression are at higher risk of vascular events than those without any progression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diabetic patients with carotid assessment | – | Other: carotid assesment by duplex ultrasonographyPatients with diabetes and a carotid assessment by duplex ultrasonography in 2012 in a monocentric diabetic unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diabetes and a carotid assessment by duplex ultrasonography in 2012 in a monocentric diabetic unit
Key inclusion criteria (3 listed)
- Age >18 ans
- Diabetes
- Carotid duplex ultrasonography in 2012
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| carotid assesment by duplex ultrasonography | Other | diabetic patients with carotid assessment |
Primary outcome
Rate of vascular events between day one and the last day of follow-up reviewed by patient examination
Time frame: Day of the last assessment of carotid atherosclerosis by duplex ultrasonography (between 01/2014 and 09/2016)
Vascular events include ischemic myocardial events, ischemic cerebrovascular events, lower limb ischemia, arterial revascularization procedure
1 secondary outcome
Rate of carotid atherosclerosis progression measured by duplex ultrasonography in percentage of stenosis
Time frame: Day of the last assessment of carotid atherosclerosis by duplex ultrasonography between 01/2014 and 09/2016.
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 11 Oct 2016.
- Derived from this study: PubMed 31934592Vouillarmet J, Marsot C, Maucort-Boulch D, Riche B, Helfre M, Grange C. Vascular Events and Carotid Atherosclerosis: A 5-Year Prospective Cohort Study in Patients with Type 2 Diabetes and a Contemporary Cardiovascular Prevention Treatment. J Diabetes Res. 2019 Dec 22;2019:9059761. doi: 10.1155/2019/9059761. eCollection 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Carotid Atherosclerosis, run by Hospices Civils de Lyon 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 3 inclusion and 1 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 11 Oct 2016. 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?
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?
Rate of vascular events between day one and the last day of follow-up reviewed by patient examination (time frame: Day of the last assessment of carotid atherosclerosis by duplex ultrasonography (between 01/2014 and 09/2016)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02929355, which also lists 1 linked publication.
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 11 Oct 2016.