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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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