Trial Outcomes & Findings for Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs (NCT NCT02343276)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

328 participants

Primary outcome timeframe

Five minutes after sheath removal

Results posted on

2019-05-31

Participant Flow

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).

Participant milestones

Participant milestones
Measure	Placebo Placebo (saline solution 10 ml) in radial artery after sheath insertion Placebo: Placebo (saline solution 10 ml) in radial artery after sheath insertion	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
Overall Study STARTED	164	164
Overall Study COMPLETED	164	164
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=164 Participants Placebo (saline solution 10 ml) in radial artery after sheath insertion Placebo: Placebo (saline solution 10 ml) in radial artery after sheath insertion	Intervention n=164 Participants 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	Total n=328 Participants Total of all reporting groups
Age, Continuous	59.79 years STANDARD_DEVIATION 11.15 • n=5 Participants	60.93 years STANDARD_DEVIATION 11.90 • n=7 Participants	60.36 years STANDARD_DEVIATION 11.45 • n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants	58 Participants n=7 Participants	116 Participants n=5 Participants
Sex: Female, Male Male	106 Participants n=5 Participants	106 Participants n=7 Participants	212 Participants n=5 Participants
Region of Enrollment Brazil	164 participants n=5 Participants	164 participants n=7 Participants	328 participants n=5 Participants
Height	1.65 METERS STANDARD_DEVIATION 0.09 • n=5 Participants	1.64 METERS STANDARD_DEVIATION 0.09 • n=7 Participants	1.65 METERS STANDARD_DEVIATION 0.09 • n=5 Participants
Weight	76.61 KILOGRAMS STANDARD_DEVIATION 28.13 • n=5 Participants	76.59 KILOGRAMS STANDARD_DEVIATION 28.47 • n=7 Participants	76.6 KILOGRAMS STANDARD_DEVIATION 28.24 • n=5 Participants
Body mass index	28.13 kg/m^2 STANDARD_DEVIATION 7.33 • n=5 Participants	28.47 kg/m^2 STANDARD_DEVIATION 7.45 • n=7 Participants	28.32 kg/m^2 STANDARD_DEVIATION 7.41 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=164 Participants Placebo (saline solution 10 ml) in radial artery after sheath insertion Placebo: Placebo (saline solution 10 ml) in radial artery after sheath insertion	Intervention n=164 Participants 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
Pain Assessment Using Visual Analogue Scale	24.75 score on a scale Standard Deviation 23.1	24.74 score on a scale Standard Deviation 26.0

SECONDARY outcome

Timeframe: Immediate

Procedure duration, from artery catheterization up to removal of sheath.

Outcome measures

Outcome measures
Measure	Placebo n=164 Participants Placebo (saline solution 10 ml) in radial artery after sheath insertion Placebo: Placebo (saline solution 10 ml) in radial artery after sheath insertion	Intervention n=164 Participants 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
Procedure Duration	22.24 minutes Standard Deviation 12.31	21.36 minutes Standard Deviation 13.57

SECONDARY outcome

Timeframe: Immediate

Total radiation required to complete the procedure.

Outcome measures

Outcome measures
Measure	Placebo n=164 Participants Placebo (saline solution 10 ml) in radial artery after sheath insertion Placebo: Placebo (saline solution 10 ml) in radial artery after sheath insertion	Intervention n=164 Participants 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
Radiation Exposure	660.92 mGy Standard Deviation 433.25	655.61 mGy Standard Deviation 441.64

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Roberto Léo da Silva

Instituto de Cardiologia de Santa Catarina

Phone: 55 48 32719077

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place