Association Between Toe-brachial Index and Coronary Calcification in Asymptomatic Patients With Type 1 and Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 707
- 试验地点
- 1
- 主要终点
- Toe-brachial index
研究概览
简要总结
Diabetes is not a coronary risk equivalent, despite cardiovascular disease is the most common cause of death in diabetes. So, to identify diabetic patients at high cardiovascular risk is necessary. Coronary artery calcification score predicts major coronary events, and improves risk reclassification in asymptomatic diabetic patients. But, cornary artery calcification score is expensive and exposes patients to radiation. So, it cannot be used for large-scale screening. It could be interesting to identify the predictive factors of coronary artery calcification score.
Toe-brachial index is relevant in diabetic patients for the screening of peripheral arterial disease, and predicts cardiovascular events.
The aim of this study is to evaluate the association between toe-brachial index and coronary artery calcification score in asymptomatic patients with type 1 or 2 diabetes. The hypothesis is that toe-brachial index is associated with high coronary artery calcification score. It could be performed first to identify patients who require a coronary artery calcification score. It measurement is reliable, fully automated, repoducible ans cost-effectiveness.
This is a cross-sectional study, with restrospective data collection. All patients addressed to a one-day hospitalization to assess cardiovascular comorbidities are eligible.
Data are collected in patients'medical records. Clinical, biological and imaging data were collected previously during their one-day hospitalization
详细描述
Cardiovascular disease is the most common cause of death in diabetes. Actually, systematic screening of asymptomatic diabetic patients for silent myocardial ischemia is highly controversial, and is recommended for selected high-risk patients.
Calcium artery calcification score predicts major coronary events, and improves risk reclassification in asymptomatic diabetic patients. The guidelines of the european society of cardiology published in 2013 recommend a screening for silent myocardial ischemia in patients with a high coronary score, without defining a cut-off value. But, assessing cardiovascular risk with calcium coronary score in all asymptomatic patients with diabetes is not feasible. In fact, calcium coronary score expose patients to radiation, is expensive, and is not easily available in health centres. It cannot be used to screen the 4 millions of diabetic patients in France. It could be interesting to identify the predictive factors of a high calcium coronary score, in order to perform coronary artery calcification score only in selected high-risk patients.
Ankle-brachial index is also a marker of cardiovascular risk. Several prospective studies revealed that a low ankle-brachial index predicts cardiovascular events and mortality, and all-cause mortality in diabetes. Nevertheless, a study involving 1343 patients with type 2 diabetes from MESA and Heinz Nixdorf Recall studies has showed that coronary artery calcification score provides better risk reclassification than ankle-brachial index.
Toe-brachial index is particularly relevant in diabetes for peripheral arterial disease screening.
The aim of this study is to evaluate the association between toe-brachial index and coronary artery calcification score in asymptomatic patients with type 1 and 2 diabetes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 ans
- •Diabetes mellitus (type 1 or 2)
- •Patients addressed to a one-day hospitalization to assess cardiovascular comorbidities, between January 2014 and May 2017, in the diabetes department, in the Pitié-Salpêtrière hospital
- •Coronary artery calcium score available
- •Toe-brachial index available
排除标准
- •History of coronary artery disease
- •History of Raynaud's syndrome
- •Opposition of the patient
结局指标
主要结局
Toe-brachial index
时间窗: During the one-day hospitalization in the diabetes department
Toe-brachial index has been performed by a clinician nurse of the diabetology department, using a fully automatic photoplethysmographic device, Systoe®. Three measurements have been performed on the first toe of both foot : the first one to permit blood volumeflow, and the mean of the others has been recorded to define toe blood pressure. Toe-brachial index is the ratio of toe systolic blood pressure and brachial systolic blood pressure. The lowest value of toe-brachial index between the right and the left side is used. Toe-brachial index cut-off is 0.7.
次要结局
- Coronary artery calcification(Through study completion, an average of 8 months.)
- Vital statuts(Through study completion, an average of 8 months.)
- Stress myocardial perfusion tomography(Through study completion, an average of 8 months.)
- Coronary angiography(Through study completion, an average of 8 months.)