Coronary Microvascular Disease, Ischemic Heart Disease, Myocardial Ischemia
Conditions
Brief 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.
Interventions
DRUGBivalirudin
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.
DRUGAdenosine
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.
DRUGHeparin
Heparin may be used as an alternative to bivalirudin at the discretion of the interventional cardiologist.
DEVICEPressure-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.
DEVICEGuiding Catheter
Medtronic's 6F Launcher Guide Catheter will be used to engage the left main coronary artery.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 125 Years
Healthy volunteers
No
Inclusion criteria
* Adult women age ≥18 years referred for coronary angiography * Stable ischemic heart disease, defined by ischemic symptoms and/or myocardial ischemia by stress testing * Administration of aspirin therapy prior to cardiac catheterization
Exclusion criteria
Pre-Cath
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelet Activity measured by the Index of Microcirculatory Resistance (IMR) | 12 Months |
| Measure of Inflammation measured by the Index of Microcirculatory Resistance (IMR) | 12 Months |
Countries
United States
Outcome results
None listed