A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction

Summary

Among patients with stable ischemic heart disease who are referred for coronary angiography, a substantial proportion have non-obstructive coronary artery disease (CAD). Ischemia based on symptoms or stress testing may be due to coronary microvascular dysfunction in up to 40% of these patients. However, the mechanisms and optimal treatment of coronary microvascular dysfunction are unknown. Aberrant platelet activity and inflammation have been hypothesized as mechanisms of microvascular dysfunction. Investigators plan to evaluate association between platelet activity, inflammation, and coronary microvascular dysfunction in stable women referred for coronary angiography, and to identify non-invasive correlates of coronary microvascular dysfunction in these patients.

Conditions

• Coronary Microvascular Disease
• Ischemic Heart Disease
• Myocardial Ischemia

Interventions

DRUG

Bivalirudin

After diagnostic catheterization, intravenous bivalirudin (Angiomax) will be administered as part of the research procedure, and a 6F-guiding catheter without side holes will be used to engage the ostium of the coronary artery.

DRUG

Adenosine

An intravenous infusion of adenosine (140 μg/kg/min) will be administered via a large peripheral or central vein to induce steady-state maximal hyperemia.

DRUG

Heparin

Heparin may be used as an alternative to bivalirudin at the discretion of the interventional cardiologist.

DEVICE

Pressure-Temperature Sensor Guidewire

Abbott's Pressure Wire X will be used to measure fractional flow reserve (FFR), cardiac magnetic resonance (CMR) and Index of Microcirculatory Resistance (IMR) in the Left Anterior Descending (LAD) Artery and major epicardial coronary vessels associated with myocardial ischemia.

DEVICE

Guiding Catheter

Medtronic's 6F Launcher Guide Catheter will be used to engage the left main coronary artery.

Sponsors & Collaborators

• NYU Langone Health

  lead OTHER

Principal Investigators

• Nathaniel Smilowitz, MD · NYU Langone Health

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

125 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-29

Primary Completion

2025-06-30

Completion

2026-06-30

Countries

• United States

Study Locations