NCT03537586

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 125 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The objectives of this study are to 1. Investigate platelet activity and inflammation in patients with and without coronary microvascular disease who are referred for coronary angiography for the evaluation of stable ischemic heart disease and are found to have non-obstructuve epicardial CAD 2. To identify correlates of coronary microvascular dysfunction in non coronary microvascular beds that can be characterized in vivo.

Conditions

• Coronary Microvascular Disease
• Ischemic Heart Disease
• Myocardial Ischemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-06-29
• Primary completion: 2025-06-30
• Completion: 2026-06-30
• First posted: 2018-05-25
• Last updated: 2025-11-28

Locations

1 site across 1 country: United States