Phase 3
N=2,040
Prevention of Radial Artery Occlusion After Transradial Access Using Nitroglycerin
Injury of Radial Artery
Bottom Line
View on ClinicalTrials.gov: NCT03158532 ↗Enrolled (actual)
2,040
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Radial Artery Occlusion — 13; 13; 10; 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nitroglycerin I (Drug); Placebo I (Drug); Nitroglycerin II (Drug); Placebo II (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Instituto de Cardiologia de Santa Catarina
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radial Artery Occlusion |
13; 13; 10; 13 | — |
| SECONDARY Late Radial Artery Occlusion |
9; 9; 7; 9 | — |
| SECONDARY Pain Assessment |
2.7; 2.4; 2.7; 2.4 | — |
| SECONDARY Spasm (Operator Evaluation) |
12; 10; 10; 12 | — |
| SECONDARY Procedure Duration |
1,193.22; 1,216.29; 1,229.83; 1,179.67 | — |
| SECONDARY Radiation Exposure |
584.52; 591.30; 599.78; 576.09 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Indication for cardiac catheterization;
- Suitable candidates for transradial approach;
- Use of 5 or 6 French sheath in the procedure;
- Signed informed consent.
Exclusion Criteria
- Unable to tolerate nitrates or known allergy to nitrates;
- Use of any nitrate, by any route of administration, up to 1 hour before the procedure;
- ST-segment elevation acute myocardial infarction patients during the first 12 hours of sympton onset;
- Intubated patients (on mechanical ventilation);
- Complications before or during procedure (cardiac arrest, pulmonary edema, cardiogenic shock, stroke);
- Prior inclusion in this trial.
Data sourced from ClinicalTrials.gov (NCT03158532). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.