Vitamin D Deficiency as Independent Predictor for Plaque Vulnerability

NCT06473337 | Completed

• 1 other identifier: 2449/2020
• Study Type: observational
• Target: 332
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency; Carotid Artery Diseases

Outcome Measures

Primary Outcomes (1)

• Vitamin D levels and its correlation with plaque vulnerability

  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 Outcomes (1)

• Vitamin D levels and its correlation with cardiac outcome

  through study completion, an average of 1 year

Interventions

Blood sample DIAGNOSTIC_TEST

Serum blood sample for Vitamin D testing

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with carotid arteriosclerosis willing to perform surgery

You may qualify if:

• Carotid arteriostenosis
• Patient eligible for carotid artery surgery

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of General Surgery, Division of Vascular Surgery

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Carotid Artery Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Christoph Neumayer, MD,Prof.

  Medical University of Vienna, Department of General Surgery, Division of Vascular Surgery

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 25, 2024
• Study Start: March 1, 2021
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

AU (1)