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

NCT ID: NCT03537586

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-29
• Study Completion Date: 2026-06-30

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.

Detailed 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.

Conditions

Coronary Microvascular Disease; Ischemic Heart Disease; Myocardial Ischemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Non-Obstructive CAD

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.

Group Type: EXPERIMENTAL

Bivalirudin

Intervention Type: 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.

Adenosine

Intervention Type: 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.

Heparin

Intervention Type: DRUG

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

Pressure-Temperature Sensor Guidewire

Intervention Type: 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.

Guiding Catheter

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Heparin

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

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Guiding Catheter

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

Intervention Type: DEVICE

Other Intervention Names

Angiomax; Adenoscan; Pressure Wire X; 6F Launcher Guide Catheter

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

• 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,

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 125 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathaniel Smilowitz, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38583174 (View on PubMed)

Other Identifiers

18-00116

Identifier Type: -

Identifier Source: org_study_id