Cardiac Catheterisation
Conditions
Keywords
Radial Spasm
Brief 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.
Interventions
DRUGNitroglycerin
Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion
OTHERPlacebo
Placebo (saline solution 10 ml) in radial artery after sheath insertion
Sponsors
Instituto de Cardiologia de Santa Catarina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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
Exclusion criteria
* AMI * Intubated patients * Complications during procedure (cardiac arrest, pulmonary edema, cardiogenic shock, stroke) * Prior inclusion in this trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Assessment Using Visual Analogue Scale | Five minutes after sheath removal | the patients' feeling of pain in the forearm, and it was measured using a visual analogue scale (VAS), applied at the end of the procedure by an interventional nurse. The VAS consists of a single line measuring 100 mm, anchored by verbal descriptors, saying 'no pain' and 'worst possible pain'. Higher values mean a worse pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Duration | Immediate | Procedure duration, from artery catheterization up to removal of sheath. |
| Radiation Exposure | Immediate | Total radiation required to complete the procedure. |
Countries
Brazil
Participant flow
Recruitment details
Study was designed as a single-centre, prospective, randomised, placebo-controlled, double-blind trial with an all-comers design. All eligible patients were aged 18 years or over with a clinical indication for coronary angiography (ad hoc angioplasty was allowed) or percutaneous coronary intervention (PCI).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo (saline solution 10 ml) in radial artery after sheath insertion
Placebo: Placebo (saline solution 10 ml) in radial artery after sheath insertion | 164 |
| Intervention Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion
Nitroglycerin: Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion | 164 |
| Total | 328 |
Baseline characteristics
| Characteristic | Placebo | Intervention | Total |
|---|---|---|---|
| Age, Continuous | 59.79 years STANDARD_DEVIATION 11.15 | 60.93 years STANDARD_DEVIATION 11.9 | 60.36 years STANDARD_DEVIATION 11.45 |
| Body mass index | 28.13 kg/m^2 STANDARD_DEVIATION 7.33 | 28.47 kg/m^2 STANDARD_DEVIATION 7.45 | 28.32 kg/m^2 STANDARD_DEVIATION 7.41 |
| Height | 1.65 METERS STANDARD_DEVIATION 0.09 | 1.64 METERS STANDARD_DEVIATION 0.09 | 1.65 METERS STANDARD_DEVIATION 0.09 |
| Region of Enrollment Brazil | 164 participants | 164 participants | 328 participants |
| Sex: Female, Male Female | 58 Participants | 58 Participants | 116 Participants |
| Sex: Female, Male Male | 106 Participants | 106 Participants | 212 Participants |
| Weight | 76.61 KILOGRAMS STANDARD_DEVIATION 28.13 | 76.59 KILOGRAMS STANDARD_DEVIATION 28.47 | 76.6 KILOGRAMS STANDARD_DEVIATION 28.24 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 164 | 0 / 164 |
| serious Total, serious adverse events | 0 / 164 | 0 / 164 |
Outcome results
Primary
Pain Assessment Using Visual Analogue Scale
the patients' feeling of pain in the forearm, and it was measured using a visual analogue scale (VAS), applied at the end of the procedure by an interventional nurse. The VAS consists of a single line measuring 100 mm, anchored by verbal descriptors, saying 'no pain' and 'worst possible pain'. Higher values mean a worse pain.
Time frame: Five minutes after sheath removal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pain Assessment Using Visual Analogue Scale | 24.75 score on a scale | Standard Deviation 23.1 |
| Intervention | Pain Assessment Using Visual Analogue Scale | 24.74 score on a scale | Standard Deviation 26 |
Secondary
Procedure Duration
Procedure duration, from artery catheterization up to removal of sheath.
Time frame: Immediate
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Procedure Duration | 22.24 minutes | Standard Deviation 12.31 |
| Intervention | Procedure Duration | 21.36 minutes | Standard Deviation 13.57 |
Secondary
Radiation Exposure
Total radiation required to complete the procedure.
Time frame: Immediate
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Radiation Exposure | 660.92 mGy | Standard Deviation 433.25 |
| Intervention | Radiation Exposure | 655.61 mGy | Standard Deviation 441.64 |