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The Association Between Systemic Microvascular Endothelial Function and Coronary Physiology Indexes

Primary Purpose

Myocardial Ischemia

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Coronary angiography with physiological lesion assessment by fractional flow reserve (FFR) and contrast fractional flow reserve (cFFR).
Sponsored by
National Institute of Cardiology, Laranjeiras, Brazil
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Ischemia focused on measuring endothelial function, coronary flow reserve, laser speckle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Institute of CardiologyRecruiting

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 8, 2023
Last Updated
May 16, 2023
Sponsor
National Institute of Cardiology, Laranjeiras, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT05864729
Brief Title
The Association Between Systemic Microvascular Endothelial Function and Coronary Physiology Indexes
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Cardiology, Laranjeiras, Brazil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia
Keywords
endothelial function, coronary flow reserve, laser speckle

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Diagnostic Test
Intervention Name(s)
Coronary angiography with physiological lesion assessment by fractional flow reserve (FFR) and contrast fractional flow reserve (cFFR).
Other Intervention Name(s)
Evaluation of systemic skin microvascular endothelial function
Intervention Description
Hemodynamic invasive study employing FFR (after intracoronary adenosine administration) and cFFR (after intracoronary lopamidol contrast media administration) measurements of hyperemic intravascular pressure.
Primary Outcome Measure Information:
Title
Assessment by fractional flow reserve (FFR) and contrast fractional flow reserve (cFFR).
Description
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.
Time Frame
day 1 visit to the hemodynamic laboratory
Secondary Outcome Measure Information:
Title
Systemic microvascular reactivity
Description
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.
Time Frame
day 1 visit to the hemodynamic laboratory

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo Tibirica, MD, PhD
Phone
21999146075
Email
etibi@uol.com.br
Facility Information:
Facility Name
National Institute of Cardiology
City
Rio de Janeiro
ZIP/Postal Code
21040-360
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Tibirica, MD, PhD
Phone
2125921265
Email
eitib@uol.com.br

12. IPD Sharing Statement

Plan to Share IPD
No

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The Association Between Systemic Microvascular Endothelial Function and Coronary Physiology Indexes

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