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临床试验/NCT05610410
NCT05610410已完成不适用

Relationship Between Regulation of Peripheral and Intracoronary Microvascular Blood Flow in Patients With Ischemia and no Obstructive Coronary Arteries

Amsterdam UMC, location VUmc1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
43
试验地点
1
主要终点
Laser speckle contrast analysis (LASCA)

研究概览

简要总结

An observational cross-sectional cohort study investigating whether peripheral endothelial function assessed using Laser speckle contrast analysis and coronary endothelial function measured with invasive coronary function testing are correlated in patients with angina and no obstructive coronary arteries.

详细描述

Rationale: Coronary endothelial dysfunction (CED) has been proposed to cause signs and symptoms of myocardial ischaemia in patients with angina but no obstructive coronary artery disease (INOCA) and has been proposed to play an important role in the pathophysiology of heart failure with preserved ejection fraction, as an element of the pro-inflammatory state causing cardiac functional and structural abnormalities in this syndrome. Research has shown that patients with coronary microvascular dysfunction (CMD) often present with echocardiographic signs of diastolic dysfunction combined with higher rates of detectable cardiac troponin and are at increased risk of developing HFpEF, indicating a major overlap in the complex pathophysiology underlying these syndromes. CED is associated with an increased risk of adverse cardiac events and currently can only be detected with invasive coronary function testing (ICFT).

However, it has been suggested that CED is a component of systemic endothelial dysfunction and is associated with endothelial dysfunction in other microvascular beds. The cutaneous microcirculation is suitable for microvascular function studies and has been shown to correlate with muscle microvascular function. The recently developed Laser speckle contrast analysis (LASCA) technique enables non-invasive monitoring of microvascular blood flow in superficial microvascular beds. In combination with iontophoresis of acetylcholine, nitroprusside and insulin, LASCA allows evaluation of peripheral microvascular endothelial and smooth muscle function. While LASCA is an established technique, the association between CED diagnosed with ICFT and an abnormal peripheral endothelial function measured by LASCA is currently unknown.

Objective: The primary objective of the study is to test whether peripheral endothelial function assessed using Laser speckle contrast analysis and CED measured with ICFT are correlated.

Study design: Observational cross-sectional cohort study.

Study population: 51 patients over the age of 18 with signs and symptoms of ischemia with no obstructive coronary arteries (INOCA) and a clinical indication for ICFT because of persistent angina without obstructive coronary artery disease and 58 patients with heart failure with preserved ejection fraction (HFpEF) and a clinical indication for ICFT.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Clinical indication for elective invasive coronary function test (ICFT)
  • Suited for one of the study groups:
  • Persistent angina, defined as symptoms of angina; or
  • HFpEF, diagnosed according to the European Society of Cardiology 2021 heart failure guidelines
  • Absence of obstructive CAD, documented before inclusion, defined as
  • Coronary Computed Tomography Angiography (CCTA) - indicative of absence of obstructed coronary arteries, or
  • Coronary angiography (CAG) - <50% diameter stenosis (DS) in the epicardial coronary arteries or (fractional flow reserve (FFR) >0.80 or instant wave free ratio (iFR) >0.89)

排除标准

  • Under 18 years of age
  • Unable or unwilling to undergo ICFT

结局指标

主要结局

Laser speckle contrast analysis (LASCA)

时间窗: 35 minutes

Peripheral microvascular function measured with Laser speckle contrast analysis (LASCA) between patients with non-obstructive coronary artery disease with and without Coronary endothelial dysfunction. LASCA measures microvasclar function non invasively by measure perfusion units (APU/mmHg.)

次要结局

  • EndoPAT(15 minutes)

研究者

发起方
Amsterdam UMC, location VUmc
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yolande Appelman

MD, PhD, FESC

VU University of Amsterdam

研究点 (1)

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