Carotid Atherosclerosis and Vascular Events in People With Diabetes

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.

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Key information

Conditions

Carotid Atherosclerosis Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebrovascular Disorders Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'Endocrinologie, Diabète et Maladie de la Nutrition, GH Sud, Hospices Civils de Lyon

Pierre-Bénite, 69310, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age >18 ans
Diabetes
Carotid duplex ultrasonography in 2012

Exclusion criteria

None

Treatment and study plan

carotid assesment by duplex ultrasonography

Other

Primary outcomes

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

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: PROCAVE-D

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Oct 11, 2016
Registry last updated: Oct 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed