- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03537586
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
January 10, 2024 updated by: NYU Langone Health
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
165
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nathaniel Smilowitz
- Phone Number: 212-263-5656
- Email: Nathaniel.Smilowitz@nyulangone.org
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- Recruiting
- New York University School of Medicine
-
Principal Investigator:
- Nathaniel Smilowitz, MD
-
Contact:
- Nathaniel R Smilowitz
- Phone Number: 212-263-5656
- Email: Nathaniel.Smilowitz@nyulangone.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 125 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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:
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:
Heparin may be used as an alternative to bivalirudin at the discretion of the interventional cardiologist.
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:
Medtronic's 6F Launcher Guide Catheter will be used to engage the left main coronary artery.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Platelet Activity measured by the Index of Microcirculatory Resistance (IMR)
Time Frame: 12 Months
|
12 Months
|
Measure of Inflammation measured by the Index of Microcirculatory Resistance (IMR)
Time Frame: 12 Months
|
12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nathaniel Smilowitz, MD, NYU Langone Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 29, 2018
Primary Completion (Estimated)
June 30, 2025
Study Completion (Estimated)
June 30, 2026
Study Registration Dates
First Submitted
May 15, 2018
First Submitted That Met QC Criteria
May 15, 2018
First Posted (Actual)
May 25, 2018
Study Record Updates
Last Update Posted (Estimated)
January 11, 2024
Last Update Submitted That Met QC Criteria
January 10, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Angina Pectoris
- Heart Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Ischemia
- Microvascular Angina
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Vasodilator Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Purinergic Agents
- Protease Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Purinergic P1 Receptor Agonists
- Purinergic Agonists
- Heparin
- Bivalirudin
- Adenosine
Other Study ID Numbers
- 18-00116
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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