Vitamin D Deficiency as Independent Predictor for Plaque Vulnerability

June 22, 2024 updated by: Stephanie Kampf, MD, Medical University of Vienna

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

332

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Department of General Surgery, Division of Vascular Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with carotid arteriosclerosis willing to perform surgery

Description

Inclusion Criteria:

  • Carotid arteriostenosis
  • Patient eligible for carotid artery surgery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Study Director: Christoph Neumayer, MD,Prof., Medical University of Vienna, Department of General Surgery, Division of Vascular Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

June 4, 2024

First Submitted That Met QC Criteria

June 22, 2024

First Posted (Actual)

June 25, 2024

Study Record Updates

Last Update Posted (Actual)

June 25, 2024

Last Update Submitted That Met QC Criteria

June 22, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2449/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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