Vitamin D Deficiency as Independent Predictor for Plaque Vulnerability

Completed

• Conditions: Vitamin D Deficiency; Carotid Artery Diseases

• Registration Number: NCT06473337
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-22
• Last Update Submitted: 2024-06-22
• Study First Posted: 2024-06-25
• Last Update Posted: 2024-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 332

Inclusion Criteria

• Carotid arteriostenosis
• Patient eligible for carotid artery surgery

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vitamin D levels and its correlation with plaque vulnerability	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 Outcome Measures

Name	Time	Method
Vitamin D levels and its correlation with cardiac outcome	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.

Trial Locations

Locations (1)

Department of General Surgery, Division of Vascular Surgery; 🇦🇹 Vienna, Austria