NCT05864729

The Association Between Systemic Microvascular Endothelial Function and Coronary Physiology Indexes

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: National Institute of Cardiology, Laranjeiras, Brazil · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Myocardial Ischemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2023-05-18
• Last updated: 2024-03-26

Locations

1 site across 1 country: Brazil