Phase 3
N=328
Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs
Cardiac Catheterisation
Bottom Line
View on ClinicalTrials.gov: NCT02343276 ↗Enrolled (actual)
328
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Pain Assessment Using Visual Analogue Scale — 24.75; 24.74 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nitroglycerin (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Instituto de Cardiologia de Santa Catarina
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Assessment Using Visual Analogue Scale |
24.75; 24.74 | — |
| SECONDARY Procedure Duration |
22.24; 21.36 | — |
| SECONDARY Radiation Exposure |
660.92; 655.61 | — |
Summary
Single-center study, randomized, double-blind, placebo controlled, with patients undergoing diagnostic or therapeutic catheterization via the transradial approach. Patients will be randomized into two groups: one group will receive the vasodilator nitroglycerin during the procedure (intervention group), and a second group will receive saline 0.9% in the same volume and time during the procedure (control group).
Will be evaluated: incidence of spasms of the radial artery, ability to perform the procedure without the need to change the access site, pain presented by the patient, time and total radiation of the procedure.
Eligibility Criteria
Inclusion Criteria
- Indication for cardiac catheterization
- Suitable candidates for transradial approach
Exclusion Criteria
- AMI
- Intubated patients
- Complications during procedure (cardiac arrest, pulmonary edema, cardiogenic shock, stroke)
- Prior inclusion in this trial
Data sourced from ClinicalTrials.gov (NCT02343276). 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.