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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04651101
Other study ID # IR.SUMS.MED.REC.1398.246
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2019
Est. completion date November 1, 2020

Study information

Verified date December 2020
Source Shiraz University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


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


Recruitment information / eligibility

Status Completed
Enrollment 4526
Est. completion date November 1, 2020
Est. primary completion date October 12, 2020
Accepts healthy volunteers
Gender All
Age group 51 Years to 75 Years
Eligibility 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


Intervention

Diagnostic Test:
coronary angiography
extent of coronary artery disease in invasive coronary angiography

Locations

Country Name City State
Iran, Islamic Republic of Professor kojuri cardiology clinic Shiraz Outside Of The US

Sponsors (1)

Lead Sponsor Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary coronary disease extent of coronary artery disease in invasive coronary angiography 2 years
Primary Hs-CRP level of blood Hs-CRP as marker of inflammation 2 years
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