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Coronary Artery DiseaseNCT04667832

ABI for Screening of Coronary Artery Disease

An observational study of Coronary Artery Disease, run by Shiraz University of Medical Sciences at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 88 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
selective coronary artery angiography
Type of treatment
Injection or infusion
How many people
4,207 participants
Where
1 siteIran
Study dates
1 Mar 2019to 1 Oct 2020
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 88 years
  • All sexes
  • Adult, Older adult

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).

Who may be able to join

  • patients who referred to Professor Kojuri cardiovascular clinic

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Iran1 site
  • Professor kojuri cardiology clinic

    Shiraz, Outside of the US, 55318

Other trials in Iran

About this study

Official title: Ankle-brachial Index a Simple and Inexpensive Screening Test for Coronary Artery Disease (ABI Goes Beyond the Foot)

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

Being tested
selective coronary artery angiography
Keywords
coronary artery disease, vitamin D deficiency
Medical subject headings
Coronary Artery Disease, Vitamin D Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • selective coronary artery angiographyDiagnostic test

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

Study groups in NCT04667832
Study groupRoleWhat they receive
abnormal ABIthose patients with ankle brachial index ( ABI) less than 0.9
Receives: Diagnostic Test: selective coronary artery angiography
normal ABIThose patients with ankle brachial index more than 0.9
Receives: Diagnostic Test: selective coronary artery angiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. coronary artery disease

    lesion more than 50% in selective coronary angiography

    Measured: 1 year

Secondary outcomes (1)
  1. Hs-CRP

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2020
  2. Study start1 Mar 2019
  3. Primary completion1 Sep 2020
  4. Study completion1 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
4,207 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT04667832
Sponsor's protocol ID
IR.SUMS.MED.REC.1398.437
Status last verified
Dec 2020
First submitted
4 Dec 2020
Last updated
22 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: not till publication

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Shiraz University of Medical Sciences at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

coronary artery disease (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.

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