NCT04651101

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,526

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2020

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
Last Updated

December 7, 2020

Status Verified

December 1, 2020

Enrollment Period

1.6 years

First QC Date

November 25, 2020

Last Update Submit

December 3, 2020

Conditions

Keywords

coronary artery diseasevitamin D deficiencyHs-CRP

Outcome Measures

Primary Outcomes (2)

  • coronary disease

    extent of coronary artery disease in invasive coronary angiography

    2 years

  • Hs-CRP

    level of blood Hs-CRP as marker of inflammation

    2 years

Study Arms (2)

vitamin D deficient

those patient with vitamin D level below 30 ng/dl

Diagnostic Test: coronary angiography

non vitamin D deficient

those patient with vitamin D above 30 ng/dl

Diagnostic Test: coronary angiography

Interventions

coronary angiographyDIAGNOSTIC_TEST

extent of coronary artery disease in invasive coronary angiography

non vitamin D deficientvitamin D deficient

Eligibility Criteria

Age51 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

those who referred for coronary angiography with suspicion to coronary artery disease, who referred to our clinic

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Professor kojuri cardiology clinic

Shiraz, Outside of the US, 55318, Iran

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Conditions

Coronary DiseaseCoronary Artery DiseaseVitamin D Deficiency

Interventions

Coronary Angiography

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisAngiographyRadiographyDiagnostic Techniques, CardiovascularHeart Function Tests

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 25, 2020

First Posted

December 3, 2020

Study Start

March 1, 2019

Primary Completion

October 12, 2020

Study Completion

November 1, 2020

Last Updated

December 7, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

not distribute till publication

Locations