Trial · NCT02832115
Topical Nitroglycerine Treatment for Radial Artery Spasm Prevention
NCT02832115, Phase 4, Completed, Aultman Health Foundation; results first posted 2020-10-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Topical Nitroglycerine Treatment for Radial Artery Spasm Prevention. Trials, record NCT02832115. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02832115
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topical Nitroglycerine Treatment for Radial Artery Spasm Prevention
- NCT number
- NCT02832115
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 100 participants, actual
- Lead sponsor
- Aultman Health Foundation
- Conditions
- Radial Artery Spasm, Angina, Coronary Artery Disease
- Interventions
- Topical Nitroglycerine, Topical Lidocaine
- First posted
- 2016-07-14
- Last updated
- 2020-10-27
- Results first posted
- 2020-10-27
- Limitations and caveats
- Slow enrollment leading to smaller sample than initially planned (100 instead of 150) Radial artery dimensions available in only 87 out of 100 participants
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Radial Artery Spasm | 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 |
| Secondary | Change in Radial Artery Dimension Measured in mm^2. | 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) |
| Secondary | Number of Patients With Procedural Failure | Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes. | Need to abort procedure or convert to transfemoral access |
| Secondary | Patient Discomfort or Pain During Procedure (Visual Analog Scale 0-10) | 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) |
| Secondary | Radial Pulse at End of Procedure | 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). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Radial Artery Spasm | Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Radial Artery Dimension Measured in mm^2. | Application of nitroglycerine / placebo until prior to arterial puncture. Approximate 60 to 120 minutes | mm^2 | MEAN | |
| SECONDARY | Number of Patients With Procedural Failure | Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Patient Discomfort or Pain During Procedure (Visual Analog Scale 0-10) | Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes. | score on a scale | MEAN | |
| SECONDARY | Radial Pulse at End of Procedure | At the end of transradial cardiac catheterization after sheath removal | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Radial Artery Spasm | Study | 8 | Participants | ||
| Radial Artery Spasm | Control | 15 | Participants | ||
| Change in Radial Artery Dimension Measured in mm^2. | Study | 2.5 | Standard Deviation 1.668937229 | mm^2 | |
| Change in Radial Artery Dimension Measured in mm^2. | Control | -0.2 | Standard Deviation 1.060927244 | mm^2 | |
| Number of Patients With Procedural Failure | Study | 0 | Participants | ||
| Number of Patients With Procedural Failure | Control | 4 | Participants | ||
| Patient Discomfort or Pain During Procedure (Visual Analog Scale 0-10) | Study | 0.792 | Standard Deviation 2.030582155 | score on a scale | |
| Patient Discomfort or Pain During Procedure (Visual Analog Scale 0-10) | Control | 0.875 | Standard Deviation 1.964529206 | score on a scale | |
| Radial Pulse at End of Procedure | Study | 2.208333333 | Standard Deviation 0.650967638 | score on a scale | |
| Radial Pulse at End of Procedure | Control | 2.166666667 | Standard Deviation 0.558620388 | score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Study | 48 | |
| Overall Study | STARTED | Control | 52 | |
| Overall Study | COMPLETED | Study | 48 | |
| Overall Study | COMPLETED | Control | 52 | |
| Overall Study | NOT COMPLETED | Study | 0 | |
| Overall Study | NOT COMPLETED | Control | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | General disorders | Study | 2 | 48 | 2 |
| other | Headache | General disorders | Control | 1 | 52 | 1 |
| other | Hematoma < 5 cm | Vascular disorders | Study | 3 | 48 | 3 |
| other | Hematoma < 5 cm | Vascular disorders | Control | 4 | 52 | 4 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Study | 0 | 48 |
| Total, all-cause mortality | Control | 0 | 52 |
| Total, other adverse events | Study | 5 | 48 |
| Total, other adverse events | Control | 5 | 52 |
| Total, serious adverse events | Study | 0 | 48 |
| Total, serious adverse events | Control | 0 | 52 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Study vs Control: Number of Patients With Procedural Failure | Trial comparisons |
| Study vs Control: deaths from any cause | Trial comparisons |
| Study vs Control: Radial Artery Spasm | Trial comparisons |
| Study vs Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02832115
GET https://conductscience.org/api/trials/v1/NCT02832115/registered