A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
Overview
- Phase
- Not Applicable
- Intervention
- Bivalirudin
- Conditions
- Coronary Microvascular Disease
- Sponsor
- NYU Langone Health
- Enrollment
- 206
- Locations
- 1
- Primary Endpoint
- Platelet Activity measured by the Index of Microcirculatory Resistance (IMR)
- Status
- Active, not recruiting
- Last Updated
- 5 months ago
Overview
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.
Investigators
Eligibility Criteria
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 Exclusion criteria:
- •Active bleeding and/or bleeding diathesis
- •Anemia (hemoglobin \<9 mg/dl)
- •Known thrombocytosis (platelet count \>500,000)
- •Know thrombocytopenia (platelet count \<100,000)
- •NSAIDs (e.g., ibuprofen, naproxen) within 3 days
- •Platelet antagonists other than aspirin and thienopyridines, within 7 days
- •Prior percutaneous coronary intervention or coronary artery bypass grafting
- •Acute myocardial infarction within 3 months
- •Severe valvular heart disease
Arms & Interventions
Non-Obstructive CAD
After diagnostic coronary angiography, invasive measures of coronary microvascular physiology will be obtained. Blood will be collected for platelet activity, inflammation and isolation of coronary endothelial cells.
Intervention: Bivalirudin
Non-Obstructive CAD
After diagnostic coronary angiography, invasive measures of coronary microvascular physiology will be obtained. Blood will be collected for platelet activity, inflammation and isolation of coronary endothelial cells.
Intervention: Adenosine
Non-Obstructive CAD
After diagnostic coronary angiography, invasive measures of coronary microvascular physiology will be obtained. Blood will be collected for platelet activity, inflammation and isolation of coronary endothelial cells.
Intervention: Heparin
Non-Obstructive CAD
After diagnostic coronary angiography, invasive measures of coronary microvascular physiology will be obtained. Blood will be collected for platelet activity, inflammation and isolation of coronary endothelial cells.
Intervention: Pressure-Temperature Sensor Guidewire
Non-Obstructive CAD
After diagnostic coronary angiography, invasive measures of coronary microvascular physiology will be obtained. Blood will be collected for platelet activity, inflammation and isolation of coronary endothelial cells.
Intervention: Guiding Catheter
Outcomes
Primary Outcomes
Platelet Activity measured by the Index of Microcirculatory Resistance (IMR)
Time Frame: 12 Months
Measure of Inflammation measured by the Index of Microcirculatory Resistance (IMR)
Time Frame: 12 Months