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This study was planned, but recruitment and enrollment never began.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intracoronary Nicardipine | Experimental | 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. |
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| Sterile Saline | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicardipine | Drug | 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 |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Savage, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D009529 | Nicardipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Randomized double blind, placebo controlled, study
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| Sterile Saline | Drug | Bolus of intracoronary sterile saline injection prior to PCI followed by an additional 2-4 doses of sterile saline depending on complexity of PCI |
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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 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |