跳至主要内容
临床试验/NCT04667832
NCT04667832已完成不适用

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

Shiraz University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 4,207 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4,207
试验地点
1
主要终点
coronary artery disease

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
30 Years 至 88 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients who referred to Professor Kojuri cardiovascular clinic

排除标准

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

结局指标

主要结局

coronary artery disease

时间窗: 1 year

lesion more than 50% in selective coronary angiography

次要结局

  • Hs-CRP(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Javad Kojuri

Professor

Shiraz University of Medical Sciences

研究点 (1)

Loading locations...

相似试验