The Association Between Systemic Microvascular Endothelial Function and Coronary Physiology Indexes

March 24, 2024 updated by: Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Eduardo Tibirica, MD, PhD
  • Phone Number: 21999146075
  • Email: etibi@uol.com.br

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 21040-360
        • National Institute of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systemic microvascular reactivity
Time Frame: day 1 visit to the hemodynamic laboratory
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Cardiology, Laranjeiras, Brazil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

May 8, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 24, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE: 28368620.7.0000.5272

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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