Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04667832 |
| Other study ID # |
IR.SUMS.MED.REC.1398.437 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2019 |
| Est. completion date |
October 1, 2020 |
Study information
| Verified date |
December 2020 |
| Source |
Shiraz University of Medical Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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. 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.
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
