Trial Outcomes & Findings for Topical Nitroglycerine Treatment for Radial Artery Spasm Prevention (NCT NCT02832115)

NCT ID: NCT02832115

Last Updated: 2020-10-27

Results Overview

Incidence of radial artery spasm indicated by a Radial artery spasm score of 1 or more. Radial artery spasm score is sum of: 1. Intraprocedural pain in the forearm aggravated by movement of the catheter/sheath - Absent :0; Present:1 2. Difficulty in manipulating the catheter- Absence :0; Present:1 3. Difficulty with sheath removal: Absent: 0; Present:1 4. Additional use of intraarterial nitroglycerine or verapamil after the initial vasodilator cocktail- No:0; Yes:1

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 100 participants
• Primary outcome timeframe: Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.
• Results posted on: 2020-10-27

Participant Flow

Participant milestones

Measure	Study 40 mg of topical lidocaine and 30 mg of topical nitroglycerine is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab. Topical Nitroglycerine: Topical nitroglycerine is applied to wrist prior to transradial cardiac catheterization to dilate radial artery and reduce spasm in study arm patients Topical Lidocaine: Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms	Control 40 mg of topical lidocaine and placebo is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab. Topical Lidocaine: Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms
Overall Study STARTED	48	52
Overall Study COMPLETED	48	52
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Study n=48 Participants 40 mg of topical lidocaine and 30 mg of topical nitroglycerine is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab. Topical Nitroglycerine: Topical nitroglycerine is applied to wrist prior to transradial cardiac catheterization to dilate radial artery and reduce spasm in study arm patients Topical Lidocaine: Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms	Control n=52 Participants 40 mg of topical lidocaine and placebo is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab. Topical Lidocaine: Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms	Total n=100 Participants Total of all reporting groups
Age, Continuous	67.45833333 years STANDARD_DEVIATION 9.828223218 • n=48 Participants	66.40384615 years STANDARD_DEVIATION 9.282620521 • n=52 Participants	66.91 years STANDARD_DEVIATION 9.466884387 • n=100 Participants
Sex: Female, Male Female	21 Participants n=48 Participants	16 Participants n=52 Participants	37 Participants n=100 Participants
Sex: Female, Male Male	27 Participants n=48 Participants	36 Participants n=52 Participants	63 Participants n=100 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Radial artery Dimension	5.6 mm^2 STANDARD_DEVIATION 2.221596993 • n=42 Participants • Only 87 of the participants had radial artery dimension change measured	6.5 mm^2 STANDARD_DEVIATION 2.450302073 • n=45 Participants • Only 87 of the participants had radial artery dimension change measured	6.1 mm^2 STANDARD_DEVIATION 2.387930965 • n=87 Participants • Only 87 of the participants had radial artery dimension change measured

PRIMARY outcome

Timeframe: Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.

Incidence of radial artery spasm indicated by a Radial artery spasm score of 1 or more. Radial artery spasm score is sum of:

1. Intraprocedural pain in the forearm aggravated by movement of the catheter/sheath - Absent :0; Present:1

2. Difficulty in manipulating the catheter- Absence :0; Present:1

3. Difficulty with sheath removal: Absent: 0; Present:1

4. Additional use of intraarterial nitroglycerine or verapamil after the initial vasodilator cocktail- No:0; Yes:1

Outcome measures

Measure	Study n=48 Participants 40 mg of topical lidocaine and 30 mg of topical nitroglycerine is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab. Topical Nitroglycerine: Topical nitroglycerine is applied to wrist prior to transradial cardiac catheterization to dilate radial artery and reduce spasm in study arm patients Topical Lidocaine: Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms	Control n=52 Participants 40 mg of topical lidocaine and placebo is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab. Topical Lidocaine: Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms
Radial Artery Spasm	8 Participants	15 Participants

SECONDARY outcome

Timeframe: Application of nitroglycerine / placebo until prior to arterial puncture. Approximate 60 to 120 minutes

Change in Radial artery cross sectional area in mm^2 - Before application of topical nitroglycerine / placebo (Pre dilation) vs Prior to arterial puncture after application of topical nitroglycerine / placebo (Post-dilation)

Outcome measures

Measure	Study n=42 Participants 40 mg of topical lidocaine and 30 mg of topical nitroglycerine is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab. Topical Nitroglycerine: Topical nitroglycerine is applied to wrist prior to transradial cardiac catheterization to dilate radial artery and reduce spasm in study arm patients Topical Lidocaine: Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms	Control n=45 Participants 40 mg of topical lidocaine and placebo is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab. Topical Lidocaine: Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms
Change in Radial Artery Dimension Measured in mm^2.	2.5 mm^2 Standard Deviation 1.668937229	-0.2 mm^2 Standard Deviation 1.060927244

SECONDARY outcome

Timeframe: Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.

Need to abort procedure or convert to transfemoral access

Outcome measures

Measure	Study n=48 Participants 40 mg of topical lidocaine and 30 mg of topical nitroglycerine is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab. Topical Nitroglycerine: Topical nitroglycerine is applied to wrist prior to transradial cardiac catheterization to dilate radial artery and reduce spasm in study arm patients Topical Lidocaine: Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms	Control n=52 Participants 40 mg of topical lidocaine and placebo is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab. Topical Lidocaine: Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms
Number of Patients With Procedural Failure	0 Participants	4 Participants

SECONDARY outcome

Timeframe: Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.

Patient discomfort or pain during procedure measured using Visual analog scale 0-10, 0 being no discomfort or pain (best) and 10 being worst discomfort or pain (worst)

Outcome measures

Measure	Study n=48 Participants 40 mg of topical lidocaine and 30 mg of topical nitroglycerine is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab. Topical Nitroglycerine: Topical nitroglycerine is applied to wrist prior to transradial cardiac catheterization to dilate radial artery and reduce spasm in study arm patients Topical Lidocaine: Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms	Control n=48 Participants 40 mg of topical lidocaine and placebo is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab. Topical Lidocaine: Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms
Patient Discomfort or Pain During Procedure (Visual Analog Scale 0-10)	0.792 score on a scale Standard Deviation 2.030582155	0.875 score on a scale Standard Deviation 1.964529206

SECONDARY outcome

Timeframe: At the end of transradial cardiac catheterization after sheath removal

Radial pulse at end of procedure 0- 4+, 0 indicating no palpable pulse (worst); 1 + indicating a faint, but detectable pulse; 2 + suggesting a slightly more diminished pulse than normal; 3 + is a normal pulse; and 4 + indicating a bounding pulse (best).

Outcome measures

Measure	Study n=48 Participants 40 mg of topical lidocaine and 30 mg of topical nitroglycerine is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab. Topical Nitroglycerine: Topical nitroglycerine is applied to wrist prior to transradial cardiac catheterization to dilate radial artery and reduce spasm in study arm patients Topical Lidocaine: Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms	Control n=48 Participants 40 mg of topical lidocaine and placebo is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab. Topical Lidocaine: Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms
Radial Pulse at End of Procedure	2.208333333 score on a scale Standard Deviation 0.650967638	2.166666667 score on a scale Standard Deviation 0.558620388

Adverse Events

Study

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Study n=48 participants at risk 40 mg of topical lidocaine and 30 mg of topical nitroglycerine is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab. Topical Nitroglycerine: Topical nitroglycerine is applied to wrist prior to transradial cardiac catheterization to dilate radial artery and reduce spasm in study arm patients Topical Lidocaine: Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms	Control n=52 participants at risk 40 mg of topical lidocaine and placebo is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab. Topical Lidocaine: Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms
General disorders Headache	4.2% 2/48 • Number of events 2 • Duration of Hospitalization during index procedure: 6 to 48 hours. Typically less than 8 hours if no intervention.	1.9% 1/52 • Number of events 1 • Duration of Hospitalization during index procedure: 6 to 48 hours. Typically less than 8 hours if no intervention.
Vascular disorders Hematoma < 5 cm	6.2% 3/48 • Number of events 3 • Duration of Hospitalization during index procedure: 6 to 48 hours. Typically less than 8 hours if no intervention.	7.7% 4/52 • Number of events 4 • Duration of Hospitalization during index procedure: 6 to 48 hours. Typically less than 8 hours if no intervention.

Additional Information

Dr. Prabhakaran Gopalakrishnan

Aultman Hospital

Phone: 3304548076

Email: prab.gopalakrishnan@aultman.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place