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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo I/Placebo II | Placebo Comparator | 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). |
|
| Nitroglycerin I/Placebo II | Experimental | 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). |
|
| Placebo I /Nitroglycerin II | Active Comparator | 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). |
|
| Nitroglycerin I /Nitroglycerin II | Experimental | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitroglycerin I | Drug | 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radial Artery Occlusion | Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular doppler ultrasound | 2 to 24 hours after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Late Radial Artery Occlusion | Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular doppler ultrasound | 30 days after procedure |
| 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) |
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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 | Study Chair |
| José R Costa Júnior, PhD | Instituto Dante Pazzanese de Cardiologia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitário Professor Polydoro Ernani de São Thiago | Florianópolis | Santa Catarina | 88036-800 | Brazil | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | Radial Artery Occlusion | Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular doppler ultrasound | Posted | Count of Participants | Participants | 2 to 24 hours after procedure |
|
30 days
Hand isquemia
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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 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roberto Léo da Silva | ISCS | 55 48 999099790 | robertoleo@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 4, 2024 | Dec 4, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005996 | Nitroglycerin |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
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|
|
| Placebo I | Drug | Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. |
|
|
| Nitroglycerin II | Drug | 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis. |
|
|
| Placebo II | Drug | Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis. |
|
|
| up to 24 hours after procedure |
| Spasm (Operator Evaluation) | Catheter friction, as experienced by the operator (subjective measure), during the realization of the procedure | During the realization of the procedure |
| Procedure Duration | Total duration of the procedure in seconds, from puncture to haemostatic dressing. | Duration of the procedure |
| Radiation Exposure | Total radiation used in the procedure | During the procedure |
| Instituto de Cardiologia de Santa Catarina |
| São Jose |
| Santa Catarina |
| 88000 |
| Brazil |
| Irmandade Santa Casa Misericórdia Marília | Marília | São Paulo | 17515-900 | Brazil |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| Secondary | Late Radial Artery Occlusion | Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular doppler ultrasound | Posted | Count of Participants | Participants | 30 days after procedure |
|
|
|
| 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) | Posted | Mean | Standard Deviation | score on a scale | up to 24 hours after procedure |
|
|
|
| Secondary | Spasm (Operator Evaluation) | Catheter friction, as experienced by the operator (subjective measure), during the realization of the procedure | Posted | Count of Participants | Participants | During the realization of the procedure |
|
|
|
| Secondary | Procedure Duration | Total duration of the procedure in seconds, from puncture to haemostatic dressing. | Posted | Mean | Standard Deviation | seconds | Duration of the procedure |
|
|
|
| Secondary | Radiation Exposure | Total radiation used in the procedure | Posted | Mean | Standard Deviation | mGy | During the procedure |
|
|
|
| 0 |
| 510 |
| 0 |
| 510 |
| 6 |
| 510 |
| EG001 | 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. | 0 | 510 | 0 | 510 | 12 | 510 |
| EG002 | 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. | 0 | 510 | 0 | 510 | 6 | 510 |
| EG003 | 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. | 0 | 510 | 0 | 510 | 13 | 510 |
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| D017606 |
| Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| Male |
|