The Association Between Systemic Microvascular Endothelial Function and Coronary Physiology Indexes

NCT ID: NCT05864729

Last Updated: 2024-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2023-12-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Evaluation of systemic skin microvascular endothelial function

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Cardiology, Laranjeiras, Brazil

OTHER_GOV

Sponsor Role: lead

Responsible Party

Eduardo Tibirica, MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Institute of Cardiology

Rio de Janeiro, , Brazil

Countries

Brazil

Other Identifiers

CAAE: 28368620.7.0000.5272

Identifier Type: -

Identifier Source: org_study_id