Cardiac Catheterization, Spasm
Conditions
Keywords
radial artery spasm
Brief summary
The aim of the study is to facilitate radial artery access for cardiac catheterization. The investigators hypothesize that topical nitroglycerin and lidocaine will reduce radial artery spasm. Patients undergoing cardiac catheterization via the radial artery will be randomized to topical nitroglycerin + lidocaine versus placebo.
Detailed description
The aim of the study is to facilitate radial artery access for cardiac catheterization. The investigators hypothesize that topical nitroglycerin and lidocaine will reduce radial artery spasm. Patients undergoing cardiac catheterization via the radial artery will be randomized to topical nitroglycerin + lidocaine versus placebo.
Interventions
DRUGNitroglycerin and lidocaine
Topical Nitroglycerin and lidocaine
OTHERPlacebo
Placebo
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Undergoing trans-radial cardiac catheterization
Exclusion criteria
* inability to receive nitroglycerin or lidocaine due to allergy or medication interactions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Radial Artery Diameter | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radial Artery Spasm During Catheterization | 2 hours | 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. |
| Radial Artery Patency | 24 hours | 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). |
Countries
United States
Participant flow
Recruitment details
Eligible patients scheduled to undergo clinically indicated diagnostic or therapeutic cardiac catheterization via the transradial approach were invited to participate in the study
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Placebo 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. | 40 |
| 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. | 43 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Access site changed to femoral artery | 1 | 0 |
| Overall Study | Insufficient ultrasound data | 2 | 0 |
Baseline characteristics
| Characteristic | Topical Dilator | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 21 Participants | 19 Participants | 40 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 21 Participants | 43 Participants |
| Age, Continuous | 63.4 years STANDARD_DEVIATION 12.6 | 59 years STANDARD_DEVIATION 12.8 | 61.2 years STANDARD_DEVIATION 12.7 |
| Region of Enrollment United States | 43 participants | 40 participants | 83 participants |
| Sex: Female, Male Female | 14 Participants | 14 Participants | 28 Participants |
| Sex: Female, Male Male | 29 Participants | 26 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 | 0 / 43 |
Outcome results
Primary
Change in Radial Artery Diameter
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.
Time frame: Baseline and after 30 minutes of drug application
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Radial Artery Diameter | -5.6 Percent change | Standard Deviation 2.1 |
| Topical Dilator | Change in Radial Artery Diameter | 16.5 Percent change | Standard Deviation 4.2 |
Secondary
Radial Artery Patency
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).
Time frame: 24 hours
Population: per protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Radial Artery Patency | Patent radial artery | 39 participants |
| Placebo | Radial Artery Patency | Early radial artery occlusion | 1 participants |
| Topical Dilator | Radial Artery Patency | Patent radial artery | 43 participants |
| Topical Dilator | Radial Artery Patency | Early radial artery occlusion | 0 participants |
Secondary
Radial Artery Spasm During Catheterization
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.
Time frame: 2 hours
Population: All participants except 3 participants in the Topical Dilator arm for whom RAS data were not recorded
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Radial Artery Spasm During Catheterization | Spasm | 10 participants |
| Placebo | Radial Artery Spasm During Catheterization | No spasm | 30 participants |
| Topical Dilator | Radial Artery Spasm During Catheterization | Spasm | 10 participants |
| Topical Dilator | Radial Artery Spasm During Catheterization | No spasm | 30 participants |