Coronary DiseaseNCT04651101
Vitamin D Deficiency in Coronary Artery Disease
An observational study of Coronary Disease, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
Large population cross sectional study, was conducted between 2018-2020 by attendance of 4526 patients in shiraz, Iran. Patients were undergone selective coronary angiography from radial artery approach by an expert interventional cardiologist. 25-hydroxy vitamin D and Hs-CRP levels were measured for all patients Read more about this study
- Who is it for?
- Ages 51 to 75 years
- Conditions the study is for
- Coronary Disease
- What is being tested?
- coronary angiography
- How many people
- 4,526 participants
- Where
- 1 siteIran
- Study dates
- 1 Mar 2019to 1 Nov 2020
- 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 51 to 75 years
- All sexes
- Adult, Older adult
Study population: those who referred for coronary angiography with suspicion to coronary artery disease, who referred to our clinic
Who may be able to join
- patients with suspected coronary artery disease who referred for coronary angiography
Who cannot join
- patients with Vitamin D more than 100ng/ml
- parathyroid disorders
- end-stage-renal-disease (ESRD)
- paraneoplastic syndromes
- Patients with more than 10mg/L Hs-CRP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Vitamin D Deficiency be a Risk Factor of Coronary Artery Disease?
Large population cross sectional study, was conducted between 2018-2020 by attendance of 4526 patients in shiraz, Iran. Patients were undergone selective coronary angiography from radial artery approach by an expert interventional cardiologist. 25-hydroxy vitamin D and Hs-CRP levels were measured for all patients
Read the detailed description
This cross-sectional study was conducted in Shiraz. Clinical data were collected from the patients of Professor Kojuri cardiovascular clinic in Shiraz, Iran ( Iran, Fars Province, Shiraz, Niayesh Boulevard, Email: kojurij@yahoo.com, webpage: http://kojuriclinic.com/ )who came to clinic from March 2018 to March 2020. Inclusion criteria was all of the new patients who referred to Professor Kojuri cardiovascular clinic. Exclusion criteria were patients with more than 100ng/ml 25-hydroxy vitamin D3 serum level, parathyroid disorders, end-stage-renal-disease (ESRD) and paraneoplastic syndromes. Patients with more than 10mg/L Hs-CRP serum level also were excluded.
Complete history and physical exam were taken from the patients and risk factors such as hypertension, diabetes mellitus, age and gender were considered. 25-hydroxy vitamin D3 was checked for all patients. Blood pressure and took electrocardiography (ECG) for all patients were done. The dependent variable was the prevalence of Coronary Artery disease; the independent variable was vitamin D deficiency; and intervening factors were age, gender, hypertension, diabetes mellitus and level of Hs-CRP.
All Patients were undergone selective coronary angiography from radial artery approach by an expert interventional cardiologist. Angiography videos were reviewed by a team of expert cardiologists. Based on the results of coronary angiography, patients were classified as non-significant CAD with stenosis less than 50% and significant CAD with stenosis more than 50% stenosis. In this review diabetic and hypertensive patients is considered by criteria of American diabetes association 2018 \& American heart association 2017 . Patient's serum level of 25-hydroxy vitamin D on their first visit was considered as index of vitamin D level. Vitamin D deficiency and sufficiency are defined respectively as serum level of 25-hydroxy vitamin D less than 30ng/ml and serum level of 25-hydroxy vitamin D more than 30 ng/ml . Patients with Parathyroid disorders and paraneoplastic syndromes were excluded
- Conditions
- Coronary Disease
- Being tested
- coronary angiography
- Keywords
- coronary artery disease, vitamin D deficiency, Hs-CRP
- Medical subject headings
- Coronary Disease, Coronary Artery Disease, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary angiographyDiagnostic test
extent of coronary artery disease in invasive coronary angiography
| Study group | Role | What they receive |
|---|---|---|
| vitamin D deficient | those patient with vitamin D level below 30 ng/dl Receives: Diagnostic Test: coronary angiography | |
| non vitamin D deficient | those patient with vitamin D above 30 ng/dl Receives: Diagnostic Test: coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
coronary disease
extent of coronary artery disease in invasive coronary angiography
Measured: 2 years
Hs-CRP
level of blood Hs-CRP as marker of inflammation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Mar 2019
- Primary completion12 Oct 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- 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
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 4,526 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javad Kojuri, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651101
- Sponsor's protocol ID
- IR.SUMS.MED.REC.1398.246
- Status last verified
- Dec 2020
- First submitted
- 25 Nov 2020
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not distribute till publication
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Vitamin D Deficiency be a Risk Factor of Coronary Artery Disease?
- ClinicalTrials.gov ID
- NCT04651101
- Acronym / sponsor ID
- IR.SUMS.MED.REC.1398.246
- Conditions
- Coronary Disease
- Keywords
- coronary artery disease, vitamin D deficiency, Hs-CRP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,526 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 12 Oct 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 3 Dec 2020 (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.
Large population cross sectional study, was conducted between 2018-2020 by attendance of 4526 patients in shiraz, Iran. Patients were undergone selective coronary angiography from radial artery approach by an expert interventional cardiologist. 25-hydroxy vitamin D and Hs-CRP levels were measured for all patients
Detailed description
This cross-sectional study was conducted in Shiraz. Clinical data were collected from the patients of Professor Kojuri cardiovascular clinic in Shiraz, Iran ( Iran, Fars Province, Shiraz, Niayesh Boulevard, Email: kojurij@yahoo.com, webpage: http://kojuriclinic.com/ )who came to clinic from March 2018 to March 2020. Inclusion criteria was all of the new patients who referred to Professor Kojuri cardiovascular clinic. Exclusion criteria were patients with more than 100ng/ml 25-hydroxy vitamin D3 serum level, parathyroid disorders, end-stage-renal-disease (ESRD) and paraneoplastic syndromes. Patients with more than 10mg/L Hs-CRP serum level also were excluded.
Complete history and physical exam were taken from the patients and risk factors such as hypertension, diabetes mellitus, age and gender were considered. 25-hydroxy vitamin D3 was checked for all patients. Blood pressure and took electrocardiography (ECG) for all patients were done. The dependent variable was the prevalence of Coronary Artery disease; the independent variable was vitamin D deficiency; and intervening factors were age, gender, hypertension, diabetes mellitus and level of Hs-CRP.
All Patients were undergone selective coronary angiography from radial artery approach by an expert interventional cardiologist. Angiography videos were reviewed by a team of expert cardiologists. Based on the results of coronary angiography, patients were classified as non-significant CAD with stenosis less than 50% and significant CAD with stenosis more than 50% stenosis. In this review diabetic and hypertensive patients is considered by criteria of American diabetes association 2018 \& American heart association 2017 . Patient's serum level of 25-hydroxy vitamin D on their first visit was considered as index of vitamin D level. Vitamin D deficiency and sufficiency are defined respectively as serum level of 25-hydroxy vitamin D less than 30ng/ml and serum level of 25-hydroxy vitamin D more than 30 ng/ml . Patients with Parathyroid disorders and paraneoplastic syndromes were excluded
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D deficient | – | Diagnostic Test: coronary angiographythose patient with vitamin D level below 30 ng/dl |
| non vitamin D deficient | – | Diagnostic Test: coronary angiographythose patient with vitamin D above 30 ng/dl |
Who may qualify
- Ages
- 51 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- those who referred for coronary angiography with suspicion to coronary artery disease, who referred to our clinic
Key inclusion criteria (1 listed)
- patients with suspected coronary artery disease who referred for coronary angiography
Key exclusion criteria (5 listed)
- patients with Vitamin D more than 100ng/ml
- parathyroid disorders
- end-stage-renal-disease (ESRD)
- paraneoplastic syndromes
- Patients with more than 10mg/L Hs-CRP
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 |
|---|---|---|
| coronary angiographyextent of coronary artery disease in invasive coronary angiography | Diagnostic test | non vitamin D deficient, vitamin D deficient |
Primary outcome
coronary disease
Time frame: 2 years
extent of coronary artery disease in invasive coronary angiography
Hs-CRP
Time frame: 2 years
level of blood Hs-CRP as marker of inflammation
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 7 Dec 2020.
- Individual participant dataSharing planned: No. not distribute till publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Coronary Disease, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 5 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 7 Dec 2020. 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 Iran. 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?
coronary disease (time frame: 2 years). The study lists 2 primary outcomes in all. 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 7 Dec 2020.