Trial Outcomes & Findings for Topical Radial Artery Vasodilation (NCT NCT01155167)

Results Overview

The cross-sectional radial artery area was measured using a high frequency linear array transducer. All ultrasound measurements were made 2 cm proximal to the radial styloid process. Each measurement was performed 3 times and averaged. At least 30 minutes after the application of topical creams, the radial artery diameter was again measured in the same fashion.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

86 participants

Primary outcome timeframe

Baseline and after 30 minutes of drug application

Results posted on

2018-09-25

Participant Flow

Eligible patients scheduled to undergo clinically indicated diagnostic or therapeutic cardiac catheterization via the transradial approach were invited to participate in the study

3 participants from the placebo group were excluded (2 secondary to insufficient or uninterpretable ultrasound data and 1 secondary to patient's access site change from transradial access (TRA) to femoral access).

Participant milestones

Participant milestones
Measure	Placebo Two placebo topical lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.	Topical Dilator 40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
Overall Study STARTED	43	43
Overall Study COMPLETED	40	43
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Two placebo topical lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.	Topical Dilator 40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
Overall Study Insufficient ultrasound data	2	0
Overall Study Access site changed to femoral artery	1	0

Baseline Characteristics

Topical Radial Artery Vasodilation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=40 Participants Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.	Topical Dilator n=43 Participants 40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.	Total n=83 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Age, Continuous	59 years STANDARD_DEVIATION 12.8 • n=5 Participants	63.4 years STANDARD_DEVIATION 12.6 • n=7 Participants	61.2 years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	29 Participants n=7 Participants	55 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	43 participants n=7 Participants	83 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and after 30 minutes of drug application

The cross-sectional radial artery area was measured using a high frequency linear array transducer. All ultrasound measurements were made 2 cm proximal to the radial styloid process. Each measurement was performed 3 times and averaged. At least 30 minutes after the application of topical creams, the radial artery diameter was again measured in the same fashion.

Outcome measures

Outcome measures
Measure	Placebo n=40 Participants Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.	Topical Dilator n=43 Participants 40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
Change in Radial Artery Diameter	-5.6 Percent change Standard Deviation 2.1	16.5 Percent change Standard Deviation 4.2

SECONDARY outcome

Timeframe: 2 hours

Population: All participants except 3 participants in the Topical Dilator arm for whom RAS data were not recorded

The blinded clinical operator recorded whether radial artery spasm occurred, as detected by resistance to advancing the catheter through the radial artery, by difficulty in torquing the catheter, or by difficulty in removing the catheter.

Outcome measures

Outcome measures
Measure	Placebo n=40 Participants Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.	Topical Dilator n=40 Participants 40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
Radial Artery Spasm During Catheterization Spasm	10 participants	10 participants
Radial Artery Spasm During Catheterization No spasm	30 participants	30 participants

SECONDARY outcome

Timeframe: 24 hours

Population: per protocol

Prior to discharge, color doppler ultrasound was used at the site where the sheath had been inserted to determine whether the radial artery was patent (open, unobstructed).

Outcome measures

Outcome measures
Measure	Placebo n=40 Participants Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.	Topical Dilator n=43 Participants 40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
Radial Artery Patency Patent radial artery	39 participants	43 participants
Radial Artery Patency Early radial artery occlusion	1 participants	0 participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Topical Dilator

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

Andrew Boyle MD

UCSF

Phone: 4153533817

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place