跳至主要内容
临床试验/NCT02705170
NCT02705170已完成不适用

Index of Microcirculatory Resistance (IMR) Assessment in Patients With New Diagnosis of Left Ventricular Dilatation Without Significant Coronary Artery Lesions: IMPAIRED Pilot Trial

University Hospital of Ferrara1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
1
主要终点
Index of microcirculatory resistance

研究概览

简要总结

To establish if, in patients with new diagnosis of left ventricular dilatation without documentation at the coronary artery angiography of significant coronary artery lesions, there is a damage of the coronary microcirculation at the IMR (index of microcirculatory resistance) assessment

详细描述

The Authors will enroll at the moment of coronary artery angiography patients without history of ischemic heart disease and new diagnosis (at transthoracic echocardiography) of left ventricular dilation.

All patients will undergo coronary artery angiography. To be enrolled, it is necessary to have the absence of significant coronary artery stenosis (angiographic evaluation of the lesion >40%) in all the vessels (main and side branch).

The Authors will proceed to perform the evaluation of the index of microvascular resistance (IMR). The target vessel will be the left anterior descending artery.

An intracoronary pressure/temperature sensor-tipped guidewire will be used. Thermodilution curves will be obtained during maximal hyperemia. The IMR will be calculated from the ratio of the mean distal coronary pressure at maximal hyperemia to the inverse of mean hyperemic transit time.

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

  • new diagnosis of left ventricular dilation (dilatative cardiopathy)
  • absence of significant (>40%) coronary artery disease at coronary artery angiography

排除标准

  • history of ischemic heart disease
  • history of significant valvular disease
  • contraindication to hyperemic agent

结局指标

主要结局

Index of microcirculatory resistance

时间窗: during coronary artery angiography

Measurement of IMR in the left anterior descending artery of patients with new diagnosis of left ventricular dilatation and no significant stenosis in epicardial coronary arteries

次要结局

  • cardiac death(1-year)

研究者

发起方
University Hospital of Ferrara
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gianluca Campo

Assistant Professor, Interventional Cardiologist

University Hospital of Ferrara

研究点 (1)

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