Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine

Study Overview
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Brief Summary
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This is a single-center double blind, placebo controlled study of patients undergoing a cardiac catheterization where the need for a percutaneous coronary intervention (PCI) is anticipated or will be determined during the early diagnostic phase. The study will assess the use of intracoronary nicardipine vs. sterile saline injection in reducing the index measurement of microcirculatory resistance (IMR). Fifty consecutive patients presenting to the Thomas Jefferson University (TJUH) Cardiac Catheterization lab will be randomized in a 1:1 fashion to receive either intracoronary nicardipine or sterile saline injection prior to PCI. IMR values will be assessed pre and post procedure. Data on clinical outcomes and adverse events will be collected by phone at 30 days and 1 year following the procedure.

Official Title
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Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Nicardipine
* Drug: Sterile Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consenting adults age > 18 years Patients with stable coronary disease, stable angina, and/or objective evidence of myocardial ischemia OR Target vessel lesion with > 50% stenosis treated by PCI Exclusion Criteria: Patients presenting with ST elevation myocardial infarction Complete total occlusion of the vessel Unprotected left main disease Presentation with acute coronary syndrome and actively rising troponin Contraindication to adenosine (advanced heart blocks, bronchospasm, HSN to the drug) Known hypersensitivity to nicardipine Severe aortic stenosis Left Ventricular dysfunction with ejection fraction less than 30% Hemodynamically unstable defined as systolic blood pressure < 90 mmHg and not responding to IV fluids Significant chronic renal insufficiency (Glomerular filtration rate [GFR] <30) Unwilling or unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized double blind, placebo controlled, study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intracoronary Nicardipine<br>200 mcg intracoronary injection of nicardipine prior to PCI, with potential for additional 100 mcg nicardipine before stent placement, balloon post-dilation, and before post-PCI IMR measurement. | Drug: Nicardipine<br>* 200 mcg intracoronary nicardipine injection prior to PCI followed by an additional 2-4 doses of 100 mcg intracoronary nicardipine depending on complexity of PCI<br>|
| Placebo Comparator: Sterile Saline<br>Injection of sterile saline prior to PCI, with potential for additional saline injections before stent placement, balloon post-dilation, and before post-PCI IMR measurement. | Drug: Sterile Saline<br>* Bolus of intracoronary sterile saline injection prior to PCI followed by an additional 2-4 doses of sterile saline depending on complexity of PCI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Index of Microcirculatory Resistance (IMR) | IMR is an intracoronary artery pressure measurement obtained during cardiac catheterization, and is a reliable indicator of microvascular dysfunction | From the start of the PCI procedure to immediately following the PCI procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-Procedure myocardial Infarction (PMI) | PMI is diagnosed by elevation of serum Troponin, 5 times the upper limit following a procedure. | 6-8 hours post procedure | 
| Post-Procedure myocardial Infarction (PMI) | PMI is diagnosed by elevation of serum Troponin, 5 times the upper limit following a procedure. | 12-18 hours post procedure | 
| Major Adverse Cardiac Event | Incidence of myocardial infarction, rehospitalization, or mortality | 30 Days following procedure | 
| Major Adverse Cardiac Event | Incidence of myocardial infarction, rehospitalization, or mortality | I year following procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nicardipine, Percutaneous Coronary Intervention, Coronary Artery Disease