Carotid Atherosclerosis and Vascular Events in People With Diabetes

Carotid Atherosclerosis Clinical Trial

— PROCAVE-D  

Official title:

Progression of Carotid Atherosclerosis and Vascular Events in People With Diabetes: A Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02929355
• Other study ID #: 69HCL16_0596
• Status: Completed
• Phase: N/A
• First received: September 23, 2016
• Last updated: October 7, 2016
• Start date: January 2012
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 731
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 ans

• Diabetes

• Carotid duplex ultrasonography in 2012

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Carotid Atherosclerosis

Intervention

Other:
• carotid assesment by duplex ultrasonography

Locations

Country	Name	City	State
France	Service d'Endocrinologie, Diabète et Maladie de la Nutrition, GH Sud, Hospices Civils de Lyon	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day of the last assessment of carotid atherosclerosis by duplex ultrasonography (between 01/2014 and 09/2016)	No
Secondary	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.	Day of the last assessment of carotid atherosclerosis by duplex ultrasonography between 01/2014 and 09/2016.	No