- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04651101
Vitamin D Deficiency in Coronary Artery Disease
Can Vitamin D Deficiency be a Risk Factor of Coronary Artery Disease?
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Outside Of The US
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Shiraz, Outside Of The US, Iran, Islamisk Republik, 55318
- Professor kojuri cardiology clinic
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
vitamin D deficient
those patient with vitamin D level below 30 ng/dl
|
extent of coronary artery disease in invasive coronary angiography
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non vitamin D deficient
those patient with vitamin D above 30 ng/dl
|
extent of coronary artery disease in invasive coronary angiography
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
coronary disease
Tidsramme: 2 years
|
extent of coronary artery disease in invasive coronary angiography
|
2 years
|
Hs-CRP
Tidsramme: 2 years
|
level of blood Hs-CRP as marker of inflammation
|
2 years
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IR.SUMS.MED.REC.1398.246
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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