Coronary Artery Disease
Conditions
Keywords
Nicardipine, Percutaneous Coronary Intervention, Coronary Artery Disease
Brief summary
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.
Interventions
DRUGNicardipine
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
DRUGSterile Saline
Bolus of intracoronary sterile saline injection prior to PCI followed by an additional 2-4 doses of sterile saline depending on complexity of PCI
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Randomized double blind, placebo controlled, study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Index of Microcirculatory Resistance (IMR) | From the start of the PCI procedure to immediately following the PCI procedure | IMR is an intracoronary artery pressure measurement obtained during cardiac catheterization, and is a reliable indicator of microvascular dysfunction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-Procedure myocardial Infarction (PMI) | 6-8 hours post procedure | PMI is diagnosed by elevation of serum Troponin, 5 times the upper limit following a procedure. |
| Major Adverse Cardiac Event | 30 Days following procedure | Incidence of myocardial infarction, rehospitalization, or mortality |
Countries
United States
Outcome results
None listed