Carotid Atherosclerosis and Vascular Events in People With Diabetes (PROCAVE-D)

October 7, 2016 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

731

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pierre-Bénite, France, 69310
        • Service d'Endocrinologie, Diabète et Maladie de la Nutrition, GH Sud, Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with diabetes and a carotid assessment by duplex ultrasonography in 2012 in a monocentric diabetic unit

Description

Inclusion Criteria:

  • Age >18 ans
  • Diabetes
  • Carotid duplex ultrasonography in 2012

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
diabetic patients with carotid assessment
Patients with diabetes and a carotid assessment by duplex ultrasonography in 2012 in a monocentric diabetic unit
Other: carotid assesment by duplex ultrasonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day of the last assessment of carotid atherosclerosis by duplex ultrasonography (between 01/2014 and 09/2016)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
Day of the last assessment of carotid atherosclerosis by duplex ultrasonography between 01/2014 and 09/2016.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

September 23, 2016

First Submitted That Met QC Criteria

October 7, 2016

First Posted (Estimate)

October 11, 2016

Study Record Updates

Last Update Posted (Estimate)

October 11, 2016

Last Update Submitted That Met QC Criteria

October 7, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL16_0596

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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