The Association Between Systemic Microvascular Endothelial Function and Coronary Physiology Indexes

Myocardial Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05864729
• Other study ID #: CAAE: 28368620.7.0000.5272
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2024
• Source: National Institute of Cardiology, Laranjeiras, Brazil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Brazil	National Institute of Cardiology	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cardiology, Laranjeiras, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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