Prevention of Radial Artery Occlusion After Transradial Access Using Nitroglycerin
NCT03158532 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2040
Last updated 2024-12-09
Summary
The radial approach for a coronary angiography has became popular in several centers because of its simplicity and fewer complications. The radial artery occlusion (RAO) is the main inconvenient and impose a limitation of future use of the radial artery as an access site for catheterization in the future. Several strategies have been used to decrease the incidence of RAO (heparin, patent hemostasis, etc). Nitrates in intra-arterial have been widely studied in prevention of this spasm. Current data show that nitroglycerin intra-arterial at the end of the procedure reduce the incidence of RAO. The hypothesis that use of nitroglycerin at the start of catheterization would have the same effect was not tested.
Conditions
- Injury of Radial Artery
Interventions
- DRUG
-
Nitroglycerin I
500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.
- DRUG
-
Placebo I
Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.
- DRUG
-
Nitroglycerin II
500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
- DRUG
-
Placebo II
Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Sponsors & Collaborators
-
Instituto de Cardiologia de Santa Catarina
lead OTHER
Principal Investigators
-
Roberto L da Silva, MD · Instituto de Cardiologia de Santa Catarina
-
José R Costa Júnior, PhD · Instituto Dante Pazzanese de Cardiologia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-07-06
- Primary Completion
- 2021-10-01
- Completion
- 2021-11-01
Countries
- Brazil
Study Locations
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