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

Myocardial Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03537586
• Other study ID #: 18-00116
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2018
• Est. completion date: June 30, 2026

Study information

• Verified date: January 2024
• Source: NYU Langone Health
• Contact: Nathaniel Smilowitz
• Phone: 212-263-5656
• Email: Nathaniel.Smilowitz[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 125 Years

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Microvascular Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Microvascular Angina
• Myocardial Ischemia

Intervention

Drug:
• Bivalirudin
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.
• Adenosine
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.
• Heparin
Heparin may be used as an alternative to bivalirudin at the discretion of the interventional cardiologist.

Device:
• Pressure-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.
• Guiding Catheter
Medtronic's 6F Launcher Guide Catheter will be used to engage the left main coronary artery.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet Activity measured by the Index of Microcirculatory Resistance (IMR)		12 Months
Primary	Measure of Inflammation measured by the Index of Microcirculatory Resistance (IMR)		12 Months