Injury of Radial Artery
Conditions
Brief 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.
Detailed description
Transradial access (TRA) has been increasingly adopted for diagnostic and interventional cardiovascular procedures in many centers worldwide. This is largely driven by the evidence supporting an unequivocal reduction in access site-related complications associated with TRA compared with transfemoral access, as well as reduction in cost and increased patient comfort. 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. RAO is the most commun complication of transradial access, and its incidence continues to reach up to 12%. Nitrates in intra-arterial have been widely studied in prevention of this spasm. Nitroglycerin binds to the surface of endothelial cells and undergoes two chemical reductions to form nitric oxide (NO). The nitric oxide then moves out of the endothelial cell and into an adjacent smooth muscle cell, where it promotes the formation of cyclic guanosine monophosphate (cGMP), which then promotes muscle relaxation. Current data show that nitroglycerin intra-arterial at the end of the procedure reduce the incidence of radial artery occlusion. A big sheath to artery size ratio could reduce the incidence of RAO, so the main objective of this study is to evaluate whether administration of nitroglycerin at the start of a transradial procedure may preserve the patency of the radial artery; as well, confirm if nitroglycerin administration just before sheet removal helps to keep the radial artery patency.
Interventions
DRUGNitroglycerin I
500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.
DRUGPlacebo I
Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.
DRUGNitroglycerin II
500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
DRUGPlacebo II
Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Sponsors
Instituto de Cardiologia de Santa Catarina
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radial Artery Occlusion | 2 to 24 hours after procedure | Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular doppler ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late Radial Artery Occlusion | 30 days after procedure | Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular doppler ultrasound |
| Pain Assessment | up to 24 hours after procedure | Pain felt by the patient in the forearm, assessed using numeric pain rating scale ranging from 0 to 10, 0 best (no pain) 10 worst (unbearable pain) |
| Spasm (Operator Evaluation) | During the realization of the procedure | Catheter friction, as experienced by the operator (subjective measure), during the realization of the procedure |
| Procedure Duration | Duration of the procedure | Total duration of the procedure in seconds, from puncture to haemostatic dressing. |
| Radiation Exposure | During the procedure | Total radiation used in the procedure |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo I/Placebo II 0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).
Placebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.
Placebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis. | 510 |
| Nitroglycerin I/Placebo II 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).
Nitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.
Placebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis. | 510 |
| Placebo I /Nitroglycerin II 0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).
Placebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.
Nitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis. | 510 |
| Nitroglycerin I /Nitroglycerin II 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).
Nitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.
Nitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis. | 510 |
| Total | 2,040 |
Baseline characteristics
| Characteristic | Placebo I/Placebo II | Nitroglycerin I/Placebo II | Placebo I /Nitroglycerin II | Nitroglycerin I /Nitroglycerin II | Total |
|---|---|---|---|---|---|
| Age, Continuous | 61.52 years STANDARD_DEVIATION 10.35 | 62.06 years STANDARD_DEVIATION 10.29 | 61.52 years STANDARD_DEVIATION 10.35 | 62.06 years STANDARD_DEVIATION 10.29 | 61.79 years STANDARD_DEVIATION 10.32 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 188 Participants | 199 Participants | 199 Participants | 188 Participants | 774 Participants |
| Sex: Female, Male Male | 322 Participants | 311 Participants | 311 Participants | 322 Participants | 1266 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 510 | 0 / 510 | 0 / 510 | 0 / 510 |
| other Total, other adverse events | 6 / 510 | 12 / 510 | 6 / 510 | 13 / 510 |
| serious Total, serious adverse events | 0 / 510 | 0 / 510 | 0 / 510 | 0 / 510 |
Outcome results
Primary
Radial Artery Occlusion
Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular doppler ultrasound
Time frame: 2 to 24 hours after procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo I/Placebo II | Radial Artery Occlusion | 13 Participants |
| Nitroglycerin I/Placebo II | Radial Artery Occlusion | 13 Participants |
| Placebo I /Nitroglycerin II | Radial Artery Occlusion | 10 Participants |
| Nitroglycerin I /Nitroglycerin II | Radial Artery Occlusion | 13 Participants |
Secondary
Late Radial Artery Occlusion
Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular doppler ultrasound
Time frame: 30 days after procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo I/Placebo II | Late Radial Artery Occlusion | 9 Participants |
| Nitroglycerin I/Placebo II | Late Radial Artery Occlusion | 9 Participants |
| Placebo I /Nitroglycerin II | Late Radial Artery Occlusion | 7 Participants |
| Nitroglycerin I /Nitroglycerin II | Late Radial Artery Occlusion | 9 Participants |
Secondary
Pain Assessment
Pain felt by the patient in the forearm, assessed using numeric pain rating scale ranging from 0 to 10, 0 best (no pain) 10 worst (unbearable pain)
Time frame: up to 24 hours after procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo I/Placebo II | Pain Assessment | 2.7 score on a scale | Standard Deviation 0.42 |
| Nitroglycerin I/Placebo II | Pain Assessment | 2.4 score on a scale | Standard Deviation 0.37 |
| Placebo I /Nitroglycerin II | Pain Assessment | 2.7 score on a scale | Standard Deviation 0.42 |
| Nitroglycerin I /Nitroglycerin II | Pain Assessment | 2.4 score on a scale | Standard Deviation 0.37 |
Secondary
Procedure Duration
Total duration of the procedure in seconds, from puncture to haemostatic dressing.
Time frame: Duration of the procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo I/Placebo II | Procedure Duration | 1,193.22 seconds |
| Nitroglycerin I/Placebo II | Procedure Duration | 1,216.29 seconds |
| Placebo I /Nitroglycerin II | Procedure Duration | 1,229.83 seconds |
| Nitroglycerin I /Nitroglycerin II | Procedure Duration | 1,179.67 seconds |
Secondary
Radiation Exposure
Total radiation used in the procedure
Time frame: During the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo I/Placebo II | Radiation Exposure | 584.52 mGy | Standard Deviation 497.54 |
| Nitroglycerin I/Placebo II | Radiation Exposure | 591.30 mGy | Standard Deviation 524.38 |
| Placebo I /Nitroglycerin II | Radiation Exposure | 599.78 mGy | Standard Deviation 559.61 |
| Nitroglycerin I /Nitroglycerin II | Radiation Exposure | 576.09 mGy | Standard Deviation 457.49 |
Secondary
Spasm (Operator Evaluation)
Catheter friction, as experienced by the operator (subjective measure), during the realization of the procedure
Time frame: During the realization of the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo I/Placebo II | Spasm (Operator Evaluation) | 12 Participants |
| Nitroglycerin I/Placebo II | Spasm (Operator Evaluation) | 10 Participants |
| Placebo I /Nitroglycerin II | Spasm (Operator Evaluation) | 10 Participants |
| Nitroglycerin I /Nitroglycerin II | Spasm (Operator Evaluation) | 12 Participants |