Coronary Microvascular DiseaseNCT03537586
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
A study testing Bivalirudin, Adenosine and Heparin in people with Coronary Microvascular Disease and Ischemic Heart Disease, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 125 years
- Conditions the study is for
- Coronary Microvascular Disease, Ischemic Heart Disease, Myocardial Ischemia
- What is being tested?
- Bivalirudin, Adenosine and Heparin
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2018to 30 Jun 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 125 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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.
Read the 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.
- Being tested
- Bivalirudin, Adenosine, Heparin, Pressure-Temperature Sensor Guidewire, Guiding Catheter
- Medical subject headings
- Microvascular Angina, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BivalirudinDrug
Also called Angiomax
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.
AdenosineDrug
Also called Adenoscan
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.
HeparinDrug
Heparin may be used as an alternative to bivalirudin at the discretion of the interventional cardiologist.
Pressure-Temperature Sensor GuidewireDevice
Also called Pressure Wire X
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 CatheterDevice
Also called 6F Launcher Guide Catheter
Medtronic's 6F Launcher Guide Catheter will be used to engage the left main coronary artery.
| Study group | Role | What they receive |
|---|---|---|
| Non-Obstructive CAD | Experimental | 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. Receives: Drug: Bivalirudin; Drug: Adenosine; Drug: Heparin; Device: Pressure-Temperature Sensor Guidewire; Device: Guiding Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Activity measured by the Index of Microcirculatory Resistance (IMR)
Measured: 12 Months
Measure of Inflammation measured by the Index of Microcirculatory Resistance (IMR)
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start29 Jun 2018
- Primary completion30 Jun 2025
- Study completion30 Jun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Microvascular DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathaniel Smilowitz, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537586
- Sponsor's protocol ID
- 18-00116
- Status last verified
- Nov 2026
- First submitted
- 15 May 2018
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38583174
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
- ClinicalTrials.gov ID
- NCT03537586
- Acronym / sponsor ID
- 18-00116
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 206 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 29 Jun 2018 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2035 (estimated)
- First posted
- 25 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-Obstructive CAD | Experimental | Drug: Bivalirudin, Drug: Adenosine, Drug: Heparin, Device: Pressure-Temperature Sensor Guidewire, Device: Guiding CatheterAfter 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. |
Who may qualify
- Ages
- 18 to 125 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BivalirudinAlso: AngiomaxAfter 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. | Drug | Non-Obstructive CAD |
| AdenosineAlso: AdenoscanAn intravenous infusion of adenosine (140 μg/kg/min) will be administered via a large peripheral or central vein to induce steady-state maximal hyperemia. | Drug | Non-Obstructive CAD |
| HeparinHeparin may be used as an alternative to bivalirudin at the discretion of the interventional cardiologist. | Drug | Non-Obstructive CAD |
| Pressure-Temperature Sensor GuidewireAlso: Pressure Wire XAbbott'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. | Device | Non-Obstructive CAD |
| Guiding CatheterAlso: 6F Launcher Guide CatheterMedtronic's 6F Launcher Guide Catheter will be used to engage the left main coronary artery. | Device | Non-Obstructive CAD |
Primary outcome
Platelet Activity measured by the Index of Microcirculatory Resistance (IMR)
Time frame: 12 Months
Measure of Inflammation measured by the Index of Microcirculatory Resistance (IMR)
Time frame: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Derived from this study: PubMed 38583174Harkin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathaniel Smilowitz, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bivalirudin, Adenosine and Heparin in people with Coronary Microvascular Disease and Ischemic Heart Disease, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet Activity measured by the Index of Microcirculatory Resistance (IMR) (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03537586, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.