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

Primary Purpose

Coronary Microvascular Disease, Ischemic Heart Disease, Myocardial Ischemia

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Bivalirudin

Adenosine

Heparin

Pressure-Temperature Sensor Guidewire

Guiding Catheter

About this trial

This is an interventional diagnostic trial for Coronary Microvascular Disease

Eligibility Criteria

18 Years - 125 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

New York University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Non-Obstructive CAD

Arm Description

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.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03537586

First Posted

May 15, 2018

Last Updated

February 23, 2023

Sponsor

NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT03537586

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 29, 2018 (Actual)

Primary Completion Date

June 30, 2025 (Anticipated)

Study Completion Date

June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Microvascular Disease, Ischemic Heart Disease, Myocardial Ischemia

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Non-Obstructive CAD

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Bivalirudin

Other Intervention Name(s)

Angiomax

Intervention Description

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

Intervention Name(s)

Adenosine

Other Intervention Name(s)

Adenoscan

Intervention Description

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

Intervention Name(s)

Heparin

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Pressure-Temperature Sensor Guidewire

Other Intervention Name(s)

Pressure Wire X

Intervention Description

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

Intervention Name(s)

Guiding Catheter

Other Intervention Name(s)

6F Launcher Guide Catheter

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

12 Months

Title

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

Time Frame

12 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

125 Years

Accepts Healthy Volunteers

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: 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nathaniel Smilowitz

Phone

212-263-5656

Nathaniel.Smilowitz@nyulangone.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nathaniel Smilowitz, MD

Organizational Affiliation

NYU Langone Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York University School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nathaniel R Smilowitz

Phone

212-263-5656

Nathaniel.Smilowitz@nyulangone.org

First Name & Middle Initial & Last Name & Degree

Nathaniel Smilowitz, MD

12. IPD Sharing Statement

Learn more about this trial

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

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