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ACTIVE NOT RECRUITING
NCT03537586
NA

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

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 125 Years

Study Type

INTERVENTIONAL

Enrollment

206

Start Date

2018-06-29

Completion Date

2026-06-30

Last Updated

2025-11-28

Healthy Volunteers

No

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.

Locations (1)

New York University School of Medicine

New York, New York, United States