Carotid Atherosclerosis and Vascular Events in People With Diabetes

Completed

• Conditions: Carotid Atherosclerosis
• Interventions: Other: carotid assesment by duplex ultrasonography

• Registration Number: NCT02929355
• Lead Sponsor: Hospices Civils de Lyon

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Study First Submitted: 2016-09-23
• Study First Submitted QC: 2016-10-07
• Last Update Submitted: 2016-10-07
• Study First Posted: 2016-10-11
• Last Update Posted: 2016-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 731

Inclusion Criteria

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
diabetic patients with carotid assessment	carotid assesment by duplex ultrasonography	Patients with diabetes and a carotid assessment by duplex ultrasonography in 2012 in a monocentric diabetic unit

Primary Outcome Measures

Name	Time	Method
Rate of vascular events between day one and the last day of follow-up reviewed by patient examination	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

Secondary Outcome Measures

Name	Time	Method
Rate of carotid atherosclerosis progression measured by duplex ultrasonography in percentage of stenosis	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.

Trial Locations

Locations (1)

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