Diagnostic Study for Heart Disease
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop taking NSAIDs (like ibuprofen or naproxen) within 3 days and any platelet antagonists other than aspirin and thienopyridines within 7 days before participation.
What data supports the effectiveness of the treatment for Coronary Microvascular Disease?
How is the treatment Diagnostic Coronary Angiography with Non-Obstructive CAD different from other treatments for heart disease?
This treatment is unique because it focuses on diagnosing and treating heart disease that originates in the small blood vessels (microcirculation) rather than the larger coronary arteries, which are often the focus of traditional heart disease treatments. It helps identify and manage conditions like microvascular angina, which are often overlooked in patients with normal-looking coronary arteries.678910
What is the purpose of this trial?
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.
Research Team
Nathaniel Smilowitz, MD
Principal Investigator
NYU Langone Health
Eligibility Criteria
This study is for adult women over 18 with stable ischemic heart disease, who are taking aspirin and referred for coronary angiography. It's not suitable for those with severe heart failure, recent heart attacks, certain blood disorders or bleeding risks, pregnancy, or known allergies to adenosine.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Diagnostic Evaluation
Participants undergo diagnostic coronary angiography and invasive measures of coronary microvascular physiology are obtained
Sample Collection and Analysis
Blood is collected for analysis of platelet activity, inflammation, and isolation of coronary endothelial cells
Follow-up
Participants are monitored for safety and effectiveness after diagnostic procedures
Treatment Details
Interventions
- Adenosine
- Bivalirudin
- Diagnostic Coronary Angiography with Non-Obstructive CAD
- Guiding Catheter
- Heparin
- Pressure-Temperature Sensor Guidewire
Diagnostic Coronary Angiography with Non-Obstructive CAD is already approved in European Union, United States for the following indications:
- Coronary microvascular dysfunction
- Non-obstructive coronary artery disease
- Coronary microvascular dysfunction
- Non-obstructive coronary artery disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
NYU Langone Health
Lead Sponsor