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Active, Not Recruiting

NCT Number: NCT03537586

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Coronary Microvascular Disease Angina Pectoris Cardiovascular Diseases Heart Diseases Ischemic Heart Disease Microvascular Angina Myocardial Ischemia Vascular Diseases

Age range

18 year–125 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

The objectives of this study are to

  • 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
  • To identify correlates of coronary microvascular dysfunction in non coronary microvascular beds that can be characterized in vivo.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: Angiomax

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.

Other names: Adenoscan

Heparin

Drug

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

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.

Other names: Pressure Wire X

Guiding Catheter

Device

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

Other names: 6F Launcher Guide Catheter

Primary outcomes

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

    Time frame: 12 Months

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

    Time frame: 12 Months

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2018
Primary completion
2025
Study completion
2026
First posted
May 25, 2018
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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