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Completed

NCT Number: NCT06473337

Vitamin D Deficiency as Independent Predictor for Plaque Vulnerability

Role of vitamin D in cardiovascular disease is controversial. Here the investigators aimed to investigate the association of vitamin D deficiency and carotid plaque morphology as well as outcome of participants with high-grade carotid artery stenosis undergoing carotid endarterectomy.

332 consecutive participants undergoing carotid endarterectomy for symptomatic or asymptomatic carotid artery stenosis, were prospectively included in the study, and vitamin D levels were determined prior to surgery using chemiluminescence-immunoassay.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebrovascular Disorders Deficiency Diseases Malnutrition Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of General Surgery, Division of Vascular Surgery

Vienna, 1090, Austria

About this study

Role of vitamin D in cardiovascular disease is controversial. Here the investigators aimed to investigate the association of vitamin D deficiency and carotid plaque morphology as well as outcome of participants with high-grade carotid artery stenosis undergoing carotid endarterectomy.

332 consecutive participants undergoing carotid endarterectomy for symptomatic or asymptomatic carotid artery stenosis, were prospectively included in the study, and vitamin D levels were determined prior to surgery using chemiluminescence-immunoassay.

There is insufficient data on cardiovascular outcome in participants with CAS and vitamin D deficiency. Vitamin D would be an easily modifiable factor.

Primary goal was to investigate the influence of vitamin D levels on plaque vulnerability, major adverse cardiovascular events (MACE) and all-cause mortality in patients with carotid artery disease undergoing carotid endarterectomy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Carotid arteriostenosis
  • Patient eligible for carotid artery surgery

Exclusion criteria

  • Oncologic disease
  • Patients with hemorrhagic, lacunar or cardioembolic stroke

Treatment and study plan

Blood sample

Diagnostic Test

Serum blood sample for Vitamin D testing

Primary outcomes

  1. Vitamin D levels and its correlation with plaque vulnerability

    Time frame: through study completion, an average of 1 year

    Vitamin D levels and its correlation with plaque vulnerability is the primary outcome measurement. Serum 25-hydroxy-vitamin D is measured by the Liaison Total 25-Hydroxy-Vitamin D chemiluminescence immunoassay (CLIA) on Liaison XL immunology analyzers (DiaSorin, Saluggia, Italy.

Secondary outcomes

  1. Vitamin D levels and its correlation with cardiac outcome

    Time frame: through study completion, an average of 1 year

    Vitamin D levels and its correlation with cardia outcome is the secondary outcome measurement. Serum 25-hydroxy-vitamin D is measured by the Liaison Total 25-Hydroxy-Vitamin D chemiluminescence immunoassay (CLIA) on Liaison XL immunology analyzers (DiaSorin, Saluggia, Italy.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Vitamin D Deficiency as Independent Predictor for Plaque Vulnerability and All-cause Mortality in Patients With Symptomatic Carotid Artery Stenosis

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 25, 2024
Registry last updated
Jun 25, 2024

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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