ABI for Screening of Coronary Artery Disease

NCT04667832 | Completed DMC

• 1 other identifier: IR.SUMS.MED.REC.1398.437
• Study Type: observational
• Target: 4,207
• Locations: 1 country
• Sites: 1

Brief Summary

Large population cross sectional study between 2019-2020 for 4207 new patients that refer to professor Kojuri cardiovascular clinic in shiraz, Iran, was conducted. Patients were undergone selective coronary angiography from radial artery approach by an expert interventional cardiologist. ABI were measured for all patients. ABI ratio was compared with the results of coronary angiography for patients who underwent coronary angiography to measure specificity and sensitivity.

Conditions

Coronary Artery Disease

Keywords

coronary artery disease; vitamin D deficiency

Outcome Measures

Primary Outcomes (1)

• coronary artery disease

  lesion more than 50% in selective coronary angiography

  1 year

Secondary Outcomes (1)

• Hs-CRP

  1 year

Study Arms (2)

abnormal ABI

those patients with ankle brachial index ( ABI) less than 0.9

Diagnostic Test: selective coronary artery angiography

normal ABI

Those patients with ankle brachial index more than 0.9

Diagnostic Test: selective coronary artery angiography

Interventions

selective coronary artery angiography DIAGNOSTIC_TEST

Radial approach, invasive selective coronary angiography with selective contrast injection and filming in coronary arteries

abnormal ABI; normal ABI

Eligibility Criteria

• Age: 30 Years - 88 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

About 4207 new patients referred to our cardiovascular clinic. 91 patients were excluded based on the Exclusion criteria. ABI was performed for 4116 patients. There were 2179(52.9%) women and 1937(47.1%) men. The mean age of the patients was 63(30-88).

You may qualify if:

• patients who referred to Professor Kojuri cardiovascular clinic

You may not qualify if:

• Patients with DVT
• Lower extremity wound that cause severe pain
• Patients who were unable to remain supine
• Patients with ABI more than 1.4

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

Professor kojuri cardiology clinic

Shiraz, Outside of the US, 55318, Iran

Location

MeSH Terms

Conditions

Coronary Artery Disease; Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 16, 2020
• Study Start: March 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: October 1, 2020
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)