NEtwork to Control ATherothrombosis (NEAT Registry) (NEAT)
2022年11月2日 更新者：Hospital do Coracao
Brazilian Registry of Atherothrombotic Disease
NEAT is an observational cohort (Prospective registry of real world data) of patients with coronary and peripheral artery disease in an outopatient setting.
研究概览
详细说明
National multicenter registry in Brazil with initial plan of 25 sites from the 5 Brazilian regions.
It will be coordinated by HCOR Research Institute which will perform regulatory, data and site management beyond academic leadership.NEAT is an observational cohort (Prospective registry of real world data) of patients with coronary and peripheral artery disease in an outopatient setting with 12 months of follow-up with collection of data at baseline, 6 months and 12 months.
研究类型
观察性的
注册 (预期的)
2000
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
SP
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São Paulo、SP、巴西、05410001
- Hospital do Coracao
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients with coronary and peripheral arterial disease in an outpatient setting
描述
Inclusion Criteria:
Patients ≥45 years followed in ambulatory setting with ≥1 of the following 3 criteria:
Documented coronary disease (≥1 criteria must apply):
- Stable angina
- History of Unstable Angina
- History of coronary angioplasty/stenting
- History of coronary artery bypass graft
- Myocardial infarction within the last 20 years
Documented symptomatic Peripheral Arterial Disease (≥1 criteria must apply):
- Previous aorto-femoral bypass surgery, limb bypass surgery, or percutaneous transluminal angioplasty revascularization of the iliac, or infra-inguinal arteries, or
- Previous limb or foot amputation for arterial vascular disease, or
- History of intermittent claudication and one or more of the following: 1) An ankle/arm blood pressure (BP) ratio < 0.90, or 2) Significant peripheral artery stenosis (≥50%) documented by angiography, or by duplex ultrasound.
Exclusion Criteria:
- Patients from institutions that don't provide the Institutional Authorization Term,
- Incapacity of follow-up in one year according to investigator judgment (severe neuropsychiatric condition, life expectancy < 12 months)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of patients receiving evidence based therapies to reduce cardiovascular risk
大体时间：Baseline
|
DOMAIN 1: Appropriate use of antithrombotic therapy
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Baseline
|
|
Percentage of patients receiving evidence based therapies to reduce cardiovascular risk
大体时间：Baseline
|
DOMAIN 2: Cholesterol control
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Baseline
|
|
Percentage of patients receiving evidence based therapies to reduce cardiovascular risk
大体时间：Baseline
|
DOMAIN 3: Blood pressure control
|
Baseline
|
|
Percentage of patients receiving evidence based therapies to reduce cardiovascular risk
大体时间：Baseline
|
DOMAIN 4: Glycemic control / diabetes treatment
|
Baseline
|
|
Percentage of patients receiving evidence based therapies to reduce cardiovascular risk
大体时间：Baseline
|
DOMAIN 5: Weight control
|
Baseline
|
|
Percentage of patients receiving evidence based therapies to reduce cardiovascular risk
大体时间：Baseline
|
DOMAIN 6: Non-pharmacological intervention: In this domain, there are 2 items to be evaluated: 1) No smoking; 2) Physical exercise ≥ 150 minutes per week.
|
Baseline
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of patients receiving complete evidence based therapies to reduce cardiovascular risk
大体时间：6 and 12 months
|
Patient should receive all of the following to consider complete evidence based therapy: Appropriate use of antithrombotic therapy; Cholesterol control; Blood pressure control; Glycemic control / diabetes treatment; Weight control; Non-pharmacological intervention
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6 and 12 months
|
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Percentage of patients with complete control of risk factors (blood pressure, cholesterol and glycemia)
大体时间：baseline, 06 and 12 months
|
blood pressure, cholesterol and glycemia levels at baseline, 06 and 12 months
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baseline, 06 and 12 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年9月30日
初级完成 (预期的)
2023年3月1日
研究完成 (预期的)
2023年4月1日
研究注册日期
首次提交
2020年12月8日
首先提交符合 QC 标准的
2020年12月15日
首次发布 (实际的)
2020年12月21日
研究记录更新
最后更新发布 (实际的)
2022年11月3日
上次提交的符合 QC 标准的更新
2022年11月2日
最后验证
2022年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.