- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04667832
ABI for Screening of Coronary Artery Disease
Ankle-brachial Index a Simple and Inexpensive Screening Test for Coronary Artery Disease (ABI Goes Beyond the Foot)
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Outside Of The US
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Shiraz, Outside Of The US, Iran, Islamic Republic of, 55318
- Professor kojuri cardiology clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients who referred to Professor Kojuri cardiovascular clinic
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
abnormal ABI
those patients with ankle brachial index ( ABI) less than 0.9
|
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
|
Radial approach, invasive selective coronary angiography with selective contrast injection and filming in coronary arteries
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
coronary artery disease
Time Frame: 1 year
|
lesion more than 50% in selective coronary angiography
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hs-CRP
Time Frame: 1 year
|
level of serum high sensitivity CRP, which ids abnormal with more than 2 mg/L
|
1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IR.SUMS.MED.REC.1398.437
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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