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

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ClinicalTrials.gov Identifier: NCT03537586
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : February 27, 2023
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Coronary Microvascular Disease Ischemic Heart Disease Myocardial Ischemia Drug: Bivalirudin Drug: Adenosine Drug: Heparin Device: Pressure-Temperature Sensor Guidewire Device: Guiding Catheter Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
Actual Study Start Date : June 29, 2018
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
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.
Other Name: Angiomax

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.
Other Name: Adenoscan

Drug: 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.
Other Name: Pressure Wire X

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

Primary Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years to 125 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537586

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Contact: Nathaniel Smilowitz 212-263-5656 Nathaniel.Smilowitz@nyulangone.org

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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Nathaniel R Smilowitz    212-263-5656    Nathaniel.Smilowitz@nyulangone.org   
Principal Investigator: Nathaniel Smilowitz, MD         
Sponsors and Collaborators
NYU Langone Health
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Principal Investigator: Nathaniel Smilowitz, MD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03537586    
Other Study ID Numbers: 18-00116
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: February 27, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Microvascular Angina
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Angina Pectoris
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents