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Phase 2, single-center, randomized, blinded clinical study to assess the safety and efficacy of topical nitroglycerin on ease of TRA during scheduled PCI. We will compare topical nitroglycerin to placebo applied prior to planned, non-urgent PCI to determine if nitroglycerin is associated with decreased number of arterial puncture attempts made, decreased time to radial access, and lower crossover rate to TFA. Subjects will be randomized to receive either topical nitroglycerin ointment or placebo prior to scheduled PCI. There will be 256 subjects enrolled in this study with 1:1 randomization.
Percutaneous coronary intervention (PCI) procedures performed by entering the radial artery, or the transradial approach (TRA), is associated with reduced vascular access site complications, bleeding, and length of hospital stay, as well as greater patient satisfaction when compared to the transfemoral approach. One of the major challenges to a successful TRA remains the small size of the radial artery. The potential need for larger catheters during PCI has been one factor limiting broader adoption of TRA and a common reason for crossover from TRA to femoral access intraprocedurally. Additionally, multiple unsuccessful attempts to access the radial artery leads to unnecessary bleeding and may lead to severe arterial vasospasms. Nitroglycerin, a vasodilator, is available in a topical form and may be used prior to PCI to dilate the radial artery and potentially increase the rate of successful TRA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo arm | Placebo Comparator | Subject will get placebo |
|
| Nitro arm | Experimental | Subject will get Nitrobid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NitroBid | Drug | We will apply nirobid to the wrist prior to left heart catheterization. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Crossover rate | • Evaluate number of attempts needed prior to successful radial artery cannulation and need for conversion to transfemoral approach | 1 year |
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Inclusion Criteria:
Exclusion Criteria
Patients with any of the following characteristics or conditions will not be included in the study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael w Foster, MD | Contact | 6107160962 | mxf314@jefferson.edu |
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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 |
|---|---|
| D005996 | Nitroglycerin |
| ID | Term |
|---|---|
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
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| Placebo |
| Drug |
We will apply placebo moisturizing cream to the wrist |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |