The Association Between Systemic Microvascular Endothelial Function and Coronary Physiology Indexes

NCT05864729 | Completed

• 1 other identifier: CAAE: 28368620.7.0000.5272
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Ischemia

Keywords

endothelial function; coronary flow reserve; laser speckle

Outcome Measures

Primary Outcomes (1)

• 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.

  day 1 visit to the hemodynamic laboratory

Secondary Outcomes (1)

• Systemic microvascular reactivity

  day 1 visit to the hemodynamic laboratory

Interventions

Coronary angiography with physiological lesion assessment by fractional flow reserve (FFR) and contrast fractional flow reserve (cFFR). DIAGNOSTIC_TEST

Hemodynamic invasive study employing FFR (after intracoronary adenosine administration) and cFFR (after intracoronary lopamidol contrast media administration) measurements of hyperemic intravascular pressure.

Also known as: Evaluation of systemic skin microvascular endothelial function

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with intermediate obstructive coronary artery disease (40-80% lumen obstruction of epicardial vessels or 30-60% obstruction of left main coronary artery).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Cardiology, Laranjeiras, Brazil: lead

Study Sites (1)

National Institute of Cardiology

Rio de Janeiro, 21040-360, Brazil

Location

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Coronary Angiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Angiography; Radiography; Diagnostic Techniques, Cardiovascular; Heart Function Tests

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 18, 2023
• Study Start: June 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)