Evaluating coronary microvascular dysfunction in women with stable ischemic heart disease

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

This study tests how platelet activity and inflammation affect small blood vessel problems in women with stable heart disease to help find better ways to understand and treat their condition.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 175 (estimated)
• Ages: 18 Years to 125 Years
• Sex: All
• Sponsor: NYU Langone Health (other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT03537586 on ClinicalTrials.gov

What this trial studies

This study investigates the relationship between platelet activity, inflammation, and coronary microvascular dysfunction in women who are referred for coronary angiography due to stable ischemic heart disease. It focuses on patients with non-obstructive coronary artery disease, aiming to identify non-invasive correlates of coronary microvascular dysfunction. The study will utilize various interventions, including bivalirudin and adenosine, to assess these associations and improve understanding of the underlying mechanisms of the condition.

Who should consider this trial

Good fit: Ideal candidates are adult women aged 18 and older with stable ischemic heart disease and non-obstructive coronary artery disease.

Not a fit: Patients with active bleeding, severe heart conditions, or recent myocardial infarction may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better diagnostic and treatment strategies for women suffering from coronary microvascular dysfunction.

How similar studies have performed: While the specific approach of this study is novel, similar studies have shown promise in understanding coronary microvascular dysfunction.

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)

Where this trial is running

New York, New York

• New York University School of Medicine — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Nathaniel Smilowitz, MD — NYU Langone Health
• Study coordinator: Nathaniel Smilowitz

Conditions: Coronary Microvascular Disease, Ischemic Heart Disease, Myocardial Ischemia