Correlation Between Physiological Measures of Ischemia in the Hemodynamics Laboratory and Systemic Microcirculatory Parameters in Patients With Intermediate Lesions of the Main Coronary Arteries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Assessment by fractional flow reserve (FFR) and contrast fractional flow reserve (cFFR).
研究概览
简要总结
The present study evaluates skin microvascular reactivity and coronary physiology in the same coronary artery disease (CAD) patients.
This study is expected to find associations between systemic microvascular reactivity, measured non-invasively at the skin surface, and coronary reserve evaluated by the invasive angiographic method.
详细描述
Introduction
Microvascular reactivity (MR) evaluated in the skin has been proposed as representative of systemic endothelial function, including coronary circulation. There is a lack of studies investigating the association between skin MR and invasive evaluation of coronary reserve. Objective: To evaluate skin MR and coronary physiology in the same coronary artery disease (CAD) patients. Methods: Transversal study, recruiting adult patients with indication for elective coronary angiographic study for the evaluation of CAD by an independent medical team. The evaluation of microvascular cutaneous blood flow of the forearm will use laser speckle contrast imaging (LSCI) coupled with acetylcholine iontophoresis. Coronary physiology will be evaluated in the same patients and in the same day with coronary angiography with lesion assessment by fractional flow reserve (FFR, after intracoronary adenosine administration) and contrast fractional flow reserve (cFFR, after intracoronary contrast media administration), with measurements of hyperemic intravascular pressures. FFR and cFFR will be performed in vessels with intermediate lesions, as evaluated in quantitative angiography. Expected results: This study is expected to find associations between systemic MR, measured non-invasively at the skin surface, and coronary reserve evaluated by the invasive angiographic method.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with intermediate obstructive coronary artery disease (40-80% lumen obstruction of epicardial vessels or 30-60% obstruction of left main coronary artery).
排除标准
- •ST elevation myocardial infarction in the first 72 hours of evolution.
- •Allergy to contrast media or adenosine
- •Asthma or chronic obstructive pulmonary artery disease diagnosis
- •Ongoing acute coronary syndrome
- •Systolic blood pressure under 90mmHg
- •Baseline arrhythmias or advanced atrioventricular blockade
- •Advanced arterial calcification
- •Renal failure (defined as serum creatinine above 1.5mg/dl)
- •Saphenous graft or mammary artery graft anastomosis stenosis
- •Severe left ventricular systolic dysfunction.
结局指标
主要结局
Assessment by fractional flow reserve (FFR) and contrast fractional flow reserve (cFFR).
时间窗: day 1 visit to the hemodynamic laboratory
Physiological coronary artery obstruction assessment through FFR and cFFR. For FFR and cFFR measurement, a 0.014FR guidewire will be advanced distal to the lesion, with baseline and hyperemic (after adenosine or contrast administration) vascular pressure measurements, with two-minute interval between each measurement.
次要结局
- Systemic microvascular reactivity(day 1 visit to the hemodynamic laboratory)
研究者
Eduardo Tibirica, MD, PhD
Principal Investigator
National Institute of Cardiology, Laranjeiras, Brazil