Carotid Atherosclerosis and Vascular Events in People With Diabetes

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02929355

Acronym

PROCAVE-D

Enrollment

731

Registered

2016-10-11

Start date

2012-01-31

Completion date

2016-09-30

Last updated

2016-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Atherosclerosis

Keywords

Carotid atherosclerosis, duplex ultrasonography, diabetes, vascular events

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.

Interventions

OTHERcarotid assesment by duplex ultrasonography

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age \>18 ans * Diabetes * Carotid duplex ultrasonography in 2012

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026