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Vitamin D Deficiency in Coronary Artery Disease

NCT ID: NCT04651101

Last Updated: 2020-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4526 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-11-01

Brief Summary

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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

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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: [email protected], 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

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Coronary Disease

Keywords

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coronary artery disease vitamin D deficiency Hs-CRP

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

RETROSPECTIVE

Study Groups

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vitamin D deficient

those patient with vitamin D level below 30 ng/dl

coronary angiography

Intervention Type DIAGNOSTIC_TEST

extent of coronary artery disease in invasive coronary angiography

non vitamin D deficient

those patient with vitamin D above 30 ng/dl

coronary angiography

Intervention Type DIAGNOSTIC_TEST

extent of coronary artery disease in invasive coronary angiography

Interventions

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coronary angiography

extent of coronary artery disease in invasive coronary angiography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* patients with suspected coronary artery disease who referred for coronary angiography

Exclusion Criteria

* 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
Minimum Eligible Age

51 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Javad Kojuri

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Professor kojuri cardiology clinic

Shiraz, Outside of the US, Iran

Site Status

Countries

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Iran

Other Identifiers

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IR.SUMS.MED.REC.1398.246

Identifier Type: -

Identifier Source: org_study_id