Vitamin D DeficiencyNCT06473337
Vitamin D Deficiency as Independent Predictor for Plaque Vulnerability
An observational study of Vitamin D Deficiency and Carotid Artery Diseases, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Vitamin D Deficiency, Carotid Artery Diseases
- What is being tested?
- Blood sample
- How many people
- 332 participants
- Where
- 1 siteAustria
- Study dates
- 1 Mar 2021to 1 Mar 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with carotid arteriosclerosis willing to perform surgery
Who may be able to join
- Carotid arteriostenosis
- Patient eligible for carotid artery surgery
Who cannot join
- Oncologic disease
- Patients with hemorrhagic, lacunar or cardioembolic stroke
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of General Surgery, Division of Vascular Surgery
Vienna, 1090
About this study
Official title: 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.
Read the 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.
- Conditions
- Vitamin D Deficiency, Carotid Artery Diseases
- Being tested
- Blood sample
- Medical subject headings
- Vitamin D Deficiency, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleDiagnostic test
Serum blood sample for Vitamin D testing
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Vitamin D levels and its correlation with cardiac outcome
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Mar 2021
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 332 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Kampf, MD, Medical University of Vienna
- Investigators
- Christoph Neumayer, MD,Prof., Study director, Medical University of Vienna, Department of General Surgery, Division of Vascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473337
- Sponsor's protocol ID
- 2449/2020
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Deficiency as Independent Predictor for Plaque Vulnerability and All-cause Mortality in Patients With Symptomatic Carotid Artery Stenosis
- ClinicalTrials.gov ID
- NCT06473337
- Acronym / sponsor ID
- 2449/2020
- Conditions
- Vitamin D Deficiency, Carotid Artery Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with carotid arteriosclerosis willing to perform surgery
Key inclusion criteria (2 listed)
- Carotid arteriostenosis
- Patient eligible for carotid artery surgery
Key exclusion criteria (2 listed)
- Oncologic disease
- Patients with hemorrhagic, lacunar or cardioembolic stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleSerum blood sample for Vitamin D testing | Diagnostic test | – |
Primary outcome
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.
1 secondary outcome
Vitamin D levels and its correlation with cardiac outcome
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Neumayer, MD,Prof. study director
Medical University of Vienna, Department of General Surgery, Division of Vascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency and Carotid Artery Diseases, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D levels and its correlation with plaque vulnerability (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.