Vitamin D Deficiency in Coronary Artery Disease

Completed

• Conditions: Coronary Disease
• Interventions: Diagnostic Test: coronary angiography

• Registration Number: NCT04651101
• Lead Sponsor: Shiraz University of Medical Sciences

Brief 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

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 Timeline

• Study Start: 2019-03-01
• Primary Completion: 2020-10-12
• Study Completion: 2020-11-01
• Study First Submitted: 2020-11-25
• Study First Submitted QC: 2020-11-25
• Status Verified: 2020-12
• Study First Posted: 2020-12-03
• Last Update Submitted: 2020-12-03
• Last Update Posted: 2020-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4526

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
vitamin D deficient	coronary angiography	those patient with vitamin D level below 30 ng/dl
non vitamin D deficient	coronary angiography	those patient with vitamin D above 30 ng/dl

Primary Outcome Measures

Name	Time	Method
coronary disease	2 years	extent of coronary artery disease in invasive coronary angiography
Hs-CRP	2 years	level of blood Hs-CRP as marker of inflammation

Trial Locations

Locations (1)

Professor kojuri cardiology clinic; 🇮🇷 Shiraz, Outside Of The US, Iran, Islamic Republic of