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CompletedNCT04667832Updated Dec 22, 2020

ABI for Screening of Coronary Artery Disease

An observational study in Coronary Artery Disease, sponsored by Shiraz University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 30 Years to 88 Years. Per ClinicalTrials.gov, last updated 2020-12-22.

Sponsored by Shiraz University of Medical Sciences · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
4,207
Ages
30 Years to 88 Years
Sex
All
01

Study 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.

Read the detailed description

This cross-sectional study was conducted between 2019 -2020. Inclusion criteria was all of the new patients who referred to Professor Kojuri cardiovascular clinic in Shiraz, Iran (Iran, Fars Province, Shiraz, Niayesh Boulevard kojurij@yahoo.com, http://kojuriclinic.com ) Exclusion criteria was Patients with DVT, Lower extremity wound that cause severe pain and patients who were unable to remain supine. Patients with ABI more than 1.4 were also Excluded.

Complete history and physical exam were taken from the patients and risk factors such as smoking, hypertension, dyslipidemia, diabetes mellitus, age and gender were considered. We checked triglyceride, total cholesterol, LDL cholesterol, HDL cholesterol, HbA1c and High sensitive CRP (Hs-CRP) for all patients. Blood pressure was measured and electrocardiography (EKG) was taken for all patients.

Dyslipidemia were defined as high total or LDL cholesterol, high triglyceride or low HDL cholesterol. Diabetes diagnosis were based on 2019 American diabetes association guideline. Hypertension were defined according to American heart association 2017.

Triglyceride more than 200, Total Cholesterol more than 200, LDL more than 100, HDL less than 40 for men and less than 50 for women, HbA1c more than 6.5 and Hs-CRP more than 2 were considered abnormal. Patients with Hs-CRP more than 10 were excluded due to possibility of Acute inflammation. Smoking were defined as regular tobacco smoking or past history of smoking within 3 months before their visit.

No evidence of abnormal findings in non-invasive studies were considered absence of CAD. Patients with strongly positive results of noninvasive studies, 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 mild proven CAD with stenosis less than 50% and severe proven CAD with stenosis more than 50% stenosis.

ABI performed for all patients with Huntleigh Dopplex ABIlity Automatic Ankle Brachial Index System. It was made in Cardiff, United kingdom. This device used Doppler ultrasound for measuring ABI. The appropriate cuffs were selected for patients. Patients were supine 30 minutes before starting test. Ankle and brachial cuffs were attached directly to the patient's skin. Both left and Right ABI were measured. ABI under 0.9 were considered as Abnormal ABI. ABI between 0.9 and 1.4 were assumed as Normal ABI. Patients with both right and left ABI between 0.9 and 1.4 were classified as normal ABI patients. Other patients with at least right or left ABI under 0.9 were considered as abnormal ABI patients. Inter-arm systolic pressure difference was also measured for patients. Inter-arm systolic pressure difference over 10mmhg were considered abnormal.

This study was double-blinded. The team of cardiologists who reported the results of coronary angiography were blinded about the results of patient's ABI. The statisticians also didn't have information about the results of ABI and coronary angiography. For blinding, we used alphabet for each group of patients with or without coronary artery disease. We also used alphabet for normal or abnormal ABI.

For statistical analysis IBM SPSS statistics version 25 was used . Independent sample t test and one-way ANOVA were used for parametric variables. We used Mann-whitney u test and Kruskal-Wallis test for nonparametric data. P value 0.05 were assumed significant.

All of the patients were informed about the details of this research and written consent were obtained from them. Patients who disagreed were excluded from this study

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • coronary artery disease
  • vitamin D deficiency
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 4,207 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Shiraz University of Medical Sciences is the lead sponsor of 129 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 88 Years
Sexes eligible
All
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).

Inclusion criteria

  • patients who referred to Professor Kojuri cardiovascular clinic

Exclusion criteria

Exclusion Criteria:

  • Patients with DVT
  • Lower extremity wound that cause severe pain
  • Patients who were unable to remain supine
  • Patients with ABI more than 1.4
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
4,207 participants (actual)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • 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

  • Diagnostic testselective coronary artery angiography

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

06

What researchers measure

Primary outcomes

  1. coronary artery disease

    lesion more than 50% in selective coronary angiography

    Time frame: 1 year

Secondary outcomes

  1. Hs-CRP

    level of serum high sensitivity CRP, which ids abnormal with more than 2 mg/L

    Time frame: 1 year

07

Study locations

1 site
  • Professor kojuri cardiology clinic
    Shiraz, Outside Of The US 55318, Iran, Islamic Republic of
08

References and documents

Individual participant data

Plan to share: No — not till publication

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04667832
Lead sponsor
Shiraz University of Medical Sciences
Responsible party
Javad Kojuri (Professor, Shiraz University of Medical Sciences) — Principal investigator
First posted
Dec 16, 2020
Start date
Mar 1, 2019
Primary completion
Sep 1, 2020
Completion
Oct 1, 2020
Last update
Dec 22, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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