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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo (saline solution 10 ml) in radial artery after sheath insertion |
|
| Intervention | Experimental | Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitroglycerin | Drug | Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Five minutes after sheath removal |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Duration | Procedure duration, from artery catheterization up to removal of sheath. | Immediate |
| Radiation Exposure | Total radiation required to complete the procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto L da Silva, MD | Instituto de Cardiologia de Santa Catarina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Cardiologia de Santa Catarina | São Jose | Santa Catarina | 88000 | Brazil |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo (saline solution 10 ml) in radial artery after sheath insertion Placebo: Placebo (saline solution 10 ml) in radial artery after sheath insertion |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo (saline solution 10 ml) in radial artery after sheath insertion Placebo: Placebo (saline solution 10 ml) in radial artery after sheath insertion |
| BG001 | Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Five minutes after sheath removal |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo (saline solution 10 ml) in radial artery after sheath insertion Placebo: Placebo (saline solution 10 ml) in radial artery after sheath insertion |
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Procedures were conducted in a single, high-volume center. All, but one, operators had high experience in radial access.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roberto Léo da Silva | Instituto de Cardiologia de Santa Catarina | 55 48 32719077 | robertoleo@hotmail.com |
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| ID | Term |
|---|---|
| D013035 | Spasm |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D005996 | Nitroglycerin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
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| Placebo | Other | Placebo (saline solution 10 ml) in radial artery after sheath insertion |
|
|
| Immediate |
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | METERS |
|
| Weight | Mean | Standard Deviation | KILOGRAMS |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
|
|
| Secondary | Procedure Duration | Procedure duration, from artery catheterization up to removal of sheath. | Posted | Mean | Standard Deviation | minutes | Immediate |
|
|
|
| Secondary | Radiation Exposure | Total radiation required to complete the procedure. | Posted | Mean | Standard Deviation | mGy | Immediate |
|
|
|
| 0 |
| 164 |
| 0 |
| 164 |
| EG001 | 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 | 0 | 164 | 0 | 164 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D012996 |
| Solutions |
| D004364 | Pharmaceutical Preparations |