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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
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
Bolus of intracoronary sterile saline injection prior to PCI followed by an additional 2-4 doses of sterile saline depending on complexity of PCI
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
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
Time frame: From the start of the PCI procedure to immediately following the PCI procedure
Post-Procedure myocardial Infarction (PMI)
PMI is diagnosed by elevation of serum Troponin, 5 times the upper limit following a procedure.
Time frame: 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.
Time frame: 12-18 hours post procedure
Major Adverse Cardiac Event
Incidence of myocardial infarction, rehospitalization, or mortality
Time frame: 30 Days following procedure
Major Adverse Cardiac Event
Incidence of myocardial infarction, rehospitalization, or mortality
Time frame: I year following procedure
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