Evaluation of the Systemic Microcirculation as a Surrogate for Coronary Microcirculation in Women With ANOCA (NOCAWT)
2026年5月2日 更新者：Eduardo Tibirica, MD, PhD、National Institute of Cardiology, Laranjeiras, Brazil
Evaluation of the Systemic Microcirculation as a Surrogate for Coronary Microcirculation in Women With ANOCA: Insights Into Pathophysiology and Diagnosis Using Noninvasive, Innovative Techniques (NOCAWT)
The primary objective of this project is to validate a multi-modal systemic microvascular phenotyping platform-combining Laser Speckle Contrast Imaging (LSCI) and Sublingual Handheld Videomicroscopy (IDF imaging)-as a non-invasive surrogate for coronary microvascular function in women with ANOCA (Angina with Non-Obstructive Coronary Arteries).
We aim to demonstrate that systemic microvascular signatures (microvascular reactivity and density) can predict coronary endotypes with high accuracy, potentially reducing the need for invasive diagnostics.
研究概览
详细说明
The study will involve women aged 18 to 65 years, with stable anginal chest pain and no coronary artery disease (ANOCA) (absence of coronary plaque in coronary angiography or computed tomography coronary angiography - CCTA), recruited at the National Institute of Cardiology (INC).
The upper age limit was established to limit the influence of vascular senescence on the results.
研究类型
观察性的
注册 (估计的)
60
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。
学习联系方式
- 姓名：Eduardo Tibirica, MD, PhD
- 电话号码：+55-21-99914-6075
- 邮箱：etibi@uol.com.br
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
- 成人
- 年长者
接受健康志愿者
不适用
取样方法
概率样本
研究人群
Patients from a terciary cardiology hospital.
描述
Inclusion Criteria:
- Age 18-65 years
- Anginal chest pain
Exclusion Criteria:
- Malignant neoplasms
- Autoimmune diseases
- Acute systemic diseases
- Pregnancy or lactation
- Iodine allergy
- CAD on invasive coronary angiography or coronary computed tomography angiography (CCTA)
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
ANOCA
Symptomatic Group (ANOCA): n = 40 patients with stable angina and non-obstructive coronary arteries.
|
Investigation of Systemic Endothelial Microvascular Function
其他名称：
|
|
CONTROL
Control Group: n = 20 age-matched women without chest pain and without CAD.
|
Investigation of Systemic Endothelial Microvascular Function
其他名称：
|
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 |
|---|---|---|
|
Evaluation of endothelium-dependent skin microvascular reactivity.
大体时间：Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
|
Evaluation of systemic microvascular reactivity induced by endothelium-dependent agent (acetylcholine).
Microvascular reactivity will be evaluated using a non-invasive and operator -independent methodology, named laser speckle contrast imaging, coupled with skin iontophoresis of vasodilator agents.
Cutaneous microvascular flow will be measured in arbitrary perfusion units, divided by mean arterial pressure, to yield cutaneous vascular conductance.
|
Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Evaluation of endothelium-independent skin microvascular reactivity.
大体时间：Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
|
Evaluation of systemic microvascular reactivity induced by endothelium-independent agent (sodium nitroprusside).
Microvascular reactivity will be evaluated using a non-invasive and operator -independent methodology, named laser speckle contrast imaging, coupled with skin iontophoresis of vasodilator agents.
Cutaneous microvascular flow will be measured in arbitrary perfusion units, divided by mean arterial pressure, to yield cutaneous vascular conductance.
|
Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
|
|
Evaluation of endothelium-dependent skin microvascular reactivity.
大体时间：Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
|
Evaluation of systemic microvascular reactivity induced by postocclusive reactive hyperemia.
Microvascular reactivity will be evaluated using a non-invasive and operator -independent methodology, named laser speckle contrast imaging.
Cutaneous microvascular flow will be measured in arbitrary perfusion units, divided by mean arterial pressure, to yield cutaneous vascular conductance.
|
Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
|
|
Evaluation of sublingual microcirculation.
大体时间：Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
|
Sublingual microcirculatory density and perfusion will be assessed using a handheld camera based on incident dark-field (IDF) imaging.
|
Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
|
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 (估计的)
2026年8月1日
初级完成 (估计的)
2029年12月1日
研究完成 (估计的)
2029年12月1日
研究注册日期
首次提交
2026年4月22日
首先提交符合 QC 标准的
2026年4月22日
首次发布 (实际的)
2026年4月30日
研究记录更新
最后更新发布 (实际的)
2026年5月5日
上次提交的符合 QC 标准的更新
2026年5月2日
最后验证
2026年5月1日
更多信息
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