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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02929355
Other study ID # 69HCL16_0596
Secondary ID
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


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
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