The Association Between Systemic Microvascular Endothelial Function and Coronary Physiology Indexes

Sponsor
National Institute of Cardiology, Laranjeiras, Brazil (Other)
Overall Status
Recruiting
CT.gov ID
NCT05864729
Collaborator
(none)
50
1
30
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Coronary angiography with physiological lesion assessment by fractional flow reserve (FFR) and contrast fractional flow reserve (cFFR).
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Assessment by fractional flow reserve (FFR) and contrast fractional flow reserve (cFFR). [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.

Secondary Outcome Measures

  1. Systemic microvascular reactivity [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Institute of Cardiology Rio de Janeiro Brazil 21040-360

Sponsors and Collaborators

  • National Institute of Cardiology, Laranjeiras, Brazil

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eduardo Tibirica, MD, PhD, Principal Investigator, National Institute of Cardiology, Laranjeiras, Brazil
ClinicalTrials.gov Identifier:
NCT05864729
Other Study ID Numbers:
  • CAAE: 28368620.7.0000.5272
First Posted:
May 18, 2023
Last Update Posted:
May 18, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eduardo Tibirica, MD, PhD, Principal Investigator, National Institute of Cardiology, Laranjeiras, Brazil
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2023