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临床试验/NCT03537586
NCT03537586进行中(未招募)不适用

A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2018年6月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
206
试验地点
1
主要终点
Platelet Activity measured by the Index of Microcirculatory Resistance (IMR)

研究概览

简要总结

Among patients with stable ischemic heart disease who are referred for coronary angiography, a substantial proportion have non-obstructive coronary artery disease (CAD). Ischemia based on symptoms or stress testing may be due to coronary microvascular dysfunction in up to 40% of these patients. However, the mechanisms and optimal treatment of coronary microvascular dysfunction are unknown. Aberrant platelet activity and inflammation have been hypothesized as mechanisms of microvascular dysfunction. Investigators plan to evaluate association between platelet activity, inflammation, and coronary microvascular dysfunction in stable women referred for coronary angiography, and to identify non-invasive correlates of coronary microvascular dysfunction in these patients.

详细描述

The objectives of this study are to

  1. Investigate platelet activity and inflammation in patients with and without coronary microvascular disease who are referred for coronary angiography for the evaluation of stable ischemic heart disease and are found to have non-obstructuve epicardial CAD
  2. To identify correlates of coronary microvascular dysfunction in non coronary microvascular beds that can be characterized in vivo.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 125 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult women age ≥18 years referred for coronary angiography
  • Stable ischemic heart disease, defined by ischemic symptoms and/or myocardial ischemia by stress testing
  • Administration of aspirin therapy prior to cardiac catheterization

排除标准

  • Pre-Cath Exclusion criteria:
  • Active bleeding and/or bleeding diathesis
  • Anemia (hemoglobin <9 mg/dl)
  • Known thrombocytosis (platelet count >500,000)
  • Know thrombocytopenia (platelet count <100,000)
  • NSAIDs (e.g., ibuprofen, naproxen) within 3 days
  • Platelet antagonists other than aspirin and thienopyridines, within 7 days
  • Prior percutaneous coronary intervention or coronary artery bypass grafting
  • Acute myocardial infarction within 3 months
  • Severe valvular heart disease
  • Cardiogenic shock or mechanical circulatory support
  • New York Heart Association (NYHA) Functional Class III or IV heart failure
  • Ejection Fraction <40%
  • Hypertrophic obstructive cardiomyopathy or severe left ventricular hypertrophy
  • Pregnancy
  • Contraindication to intravenous infusion of adenosine during coronary angiography, due to known hypersensitivity to adenosine, known or suspected bronchoconstrictive or bronchospastic lung disease (severe asthma), second- or third-degree AV block (except in patients with a functioning artificial pacemaker), or sinus node disease, such as sick sinus syndrome or symptomatic bradycardia,
  • Angiographic Exclusion criteria:
  • Obstructive CAD (≥50% luminal obstruction in ≥1 major epicardial coronary arteries by invasive coronary angiography)
  • Unfavorable coronary artery anatomy for guidewire positioning (as determined by the angiographer or PI)

研究组 & 干预措施

Non-Obstructive CAD

Experimental

After diagnostic coronary angiography, invasive measures of coronary microvascular physiology will be obtained. Blood will be collected for platelet activity, inflammation and isolation of coronary endothelial cells.

干预措施: Bivalirudin (Drug)

Non-Obstructive CAD

Experimental

After diagnostic coronary angiography, invasive measures of coronary microvascular physiology will be obtained. Blood will be collected for platelet activity, inflammation and isolation of coronary endothelial cells.

干预措施: Adenosine (Drug)

Non-Obstructive CAD

Experimental

After diagnostic coronary angiography, invasive measures of coronary microvascular physiology will be obtained. Blood will be collected for platelet activity, inflammation and isolation of coronary endothelial cells.

干预措施: Heparin (Drug)

Non-Obstructive CAD

Experimental

After diagnostic coronary angiography, invasive measures of coronary microvascular physiology will be obtained. Blood will be collected for platelet activity, inflammation and isolation of coronary endothelial cells.

干预措施: Pressure-Temperature Sensor Guidewire (Device)

Non-Obstructive CAD

Experimental

After diagnostic coronary angiography, invasive measures of coronary microvascular physiology will be obtained. Blood will be collected for platelet activity, inflammation and isolation of coronary endothelial cells.

干预措施: Guiding Catheter (Device)

结局指标

主要结局

Platelet Activity measured by the Index of Microcirculatory Resistance (IMR)

时间窗: 12 Months

Measure of Inflammation measured by the Index of Microcirculatory Resistance (IMR)

时间窗: 12 Months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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