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

NCT03537586 | Active Not Recruiting

• 1 other identifier: 18-00116
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Microvascular Disease; Ischemic Heart Disease; Myocardial Ischemia

Outcome Measures

Primary Outcomes (2)

• Platelet Activity measured by the Index of Microcirculatory Resistance (IMR)

  12 Months

• Measure of Inflammation measured by the Index of Microcirculatory Resistance (IMR)

  12 Months

Study Arms (1)

Non-Obstructive CAD

EXPERIMENTAL

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.

Drug: Bivalirudin; Drug: Adenosine; Drug: Heparin; Device: Pressure-Temperature Sensor Guidewire; Device: Guiding Catheter

Interventions

Bivalirudin DRUG

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.

Also known as: Angiomax

Non-Obstructive CAD

Adenosine DRUG

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.

Also known as: Adenoscan

Non-Obstructive CAD

Heparin DRUG

Heparin may be used as an alternative to bivalirudin at the discretion of the interventional cardiologist.

Non-Obstructive CAD

Pressure-Temperature Sensor Guidewire DEVICE

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.

Also known as: Pressure Wire X

Non-Obstructive CAD

Guiding Catheter DEVICE

Medtronic's 6F Launcher Guide Catheter will be used to engage the left main coronary artery.

Also known as: 6F Launcher Guide Catheter

Non-Obstructive CAD

Eligibility Criteria

• Age: 18 Years - 125 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (1)

• Harkin KL, Loftspring E, Beaty W, Joa A, Serrano-Gomez C, Farid A, Hausvater A, Reynolds HR, Smilowitz NR. Visual Estimates of Coronary Slow Flow Are Not Associated With Invasive Wire-Based Diagnoses of Coronary Microvascular Dysfunction. Circ Cardiovasc Interv. 2024 Jun;17(6):e013902. doi: 10.1161/CIRCINTERVENTIONS.123.013902. Epub 2024 Apr 7.

  PMID: 38583174 DERIVED

MeSH Terms

Conditions

Microvascular Angina; Myocardial Ischemia

Interventions

bivalirudin; Adenosine; Heparin

Condition Hierarchy (Ancestors)

Angina Pectoris; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Nathaniel Smilowitz, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 25, 2018
• Study Start: June 29, 2018
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

US (1)