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

Launched by NYU LANGONE HEALTH · May 15, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a condition called coronary microvascular dysfunction, which can cause heart problems in some patients who have stable ischemic heart disease (a type of heart disease characterized by reduced blood flow). The researchers want to understand how certain factors, like platelet activity (how blood cells that help with clotting behave) and inflammation, might be linked to this condition in women who are referred for a procedure called coronary angiography (a test to see if there are blockages in the heart's arteries). By identifying non-invasive ways to assess coronary microvascular dysfunction, the study aims to improve diagnosis and treatment for patients experiencing heart-related symptoms.

To participate in this trial, women must be at least 18 years old and have stable ischemic heart disease, meaning they experience heart-related symptoms or have shown signs of reduced blood flow during stress tests. Participants will need to be on aspirin therapy before the heart test. However, certain conditions would exclude someone from participating, such as having severe anemia, bleeding disorders, or a recent heart attack. Those who qualify can expect to undergo tests to evaluate their heart health and help researchers learn more about this condition, ultimately aiming to enhance care for future patients.

Gender

ALL

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
• • Cardiogenic shock or mechanical circulatory support
• • New York Heart Association (NYHA) Functional Class III or IV heart failure
• • Ejection Fraction \<40%
• • Hypertrophic obstructive cardiomyopathy or severe left ventricular hypertrophy
• • Pregnancy
• • Contraindication to intravenous infusion of adenosine during coronary angiography, due to known hypersensitivity to adenosine, known or suspected bronchoconstrictive or bronchospastic lung disease (severe asthma), second- or third-degree AV block (except in patients with a functioning artificial pacemaker), or sinus node disease, such as sick sinus syndrome or symptomatic bradycardia,
• Angiographic Exclusion criteria:
• • Obstructive CAD (≥50% luminal obstruction in ≥1 major epicardial coronary arteries by invasive coronary angiography)
• • Unfavorable coronary artery anatomy for guidewire positioning (as determined by the angiographer or PI)