Current partner codePEPTIDESDE
NCT03537586·Not applicable·INTERVENTIONAL

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

Status

Active, not recruiting

Phase

Not applicable

Enrollment

206

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

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.

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.

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.

DEVICE

Guiding Catheter

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

Timeline

From registration to results.

  1. First posted

    May 25, 2018

  2. Study start

    Jun 29, 2018

  3. Primary completion

    Jun 30, 2025

  4. Study completion

    Jun 30, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Nov 28, 2025

Outcomes

What the study measures.

Primary outcomes

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

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
125 Years
Sex
ALL
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)

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

New York University School of Medicine

New York, New York, United States

Related trials

More studies on Bivalirudin.

Related PeptideStat pages

Put the record in context.

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