Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
4207 participants
OBSERVATIONAL
2019-03-01
2020-10-01
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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abnormal ABI
those patients with ankle brachial index ( ABI) less than 0.9
selective coronary artery angiography
Radial approach, invasive selective coronary angiography with selective contrast injection and filming in coronary arteries
normal ABI
Those patients with ankle brachial index more than 0.9
selective coronary artery angiography
Radial approach, invasive selective coronary angiography with selective contrast injection and filming in coronary arteries
Interventions
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selective coronary artery angiography
Radial approach, invasive selective coronary angiography with selective contrast injection and filming in coronary arteries
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Lower extremity wound that cause severe pain
* Patients who were unable to remain supine
* Patients with ABI more than 1.4
30 Years
88 Years
ALL
No
Sponsors
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Shiraz University of Medical Sciences
OTHER
Responsible Party
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Javad Kojuri
Professor
Locations
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Professor kojuri cardiology clinic
Shiraz, Outside of the US, Iran
Countries
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Other Identifiers
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IR.SUMS.MED.REC.1398.437
Identifier Type: -
Identifier Source: org_study_id