The Association Between Systemic Microvascular Endothelial Function and Coronary Physiology Indexes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Correlation Between Physiological Measures of Ischemia in the Hemodynamics Laboratory and Systemic Microcirculatory Parameters in Patients With Intermediate Lesions of the Main Coronary Arteries

Conditions
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Myocardial Ischemia

Intervention / Treatment
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* Diagnostic Test: Coronary angiography with physiological lesion assessment by fractional flow reserve (FFR) and contrast fractional flow reserve (cFFR).


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with intermediate obstructive coronary artery disease (40-80% lumen obstruction of epicardial vessels or 30-60% obstruction of left main coronary artery). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Coronary angiography with physiological lesion assessment by fractional flow reserve (FFR) and contrast fractional flow reserve (cFFR).|Hemodynamic invasive study employing FFR (after intracoronary adenosine administration) and cFFR (after intracoronary lopamidol contrast media administration) measurements of hyperemic intravascular pressure.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment by fractional flow reserve (FFR) and contrast fractional flow reserve (cFFR). | 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. | day 1 visit to the hemodynamic laboratory | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic microvascular reactivity | Laser-based method for evaluating non-invasive, operator-independent systemic microvascular function that detects microvascular flow in the skin for the evaluation of systemic vascular endothelial function. | day 1 visit to the hemodynamic laboratory | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endothelial function, coronary flow reserve, laser speckle