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NCT02832115 · ClinicalTrials.gov registry record · Phase 4
Topical Nitroglycerine Treatment for Radial Artery Spasm Prevention
A Phase 4 study, sponsored by Aultman Health Foundation.
- Completed
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
NCT02832115: Completed Phase 4 study, sponsored by Aultman Health Foundation.
NCT02832115 is a Phase 4 study that has completed, run by Aultman Health Foundation. The registered enrollment target is 100 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02832115, a Phase 4 study, has completed, sponsored by Aultman Health Foundation.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
Study Summary
The primary objective of the study is to determine the role of transdermal vasodilators as an adjunct to parenteral vasodilators in reducing radial artery spasm, improving patient comfort, and post procedure radial artery patency during transradial coronary angiograms and interventions. The study hypothesis is that transdermal vasodilators will increase radial artery size and reduce radial artery spasm as well as improve patient comfort and post procedure radial artery patency. This is a single-center, double-blind, randomized, placebo-controlled study comparing the effect of transdermal preparations of lidocaine + nitroglycerine and lidocaine + placebo on radial artery spasm in patients undergoing transdermal coronary angiograms. Prior to the procedure, each patient will be randomized into either the control arm, lidocaine + placebo, or study arm, lidocaine + nitroglycerine.
Primary Outcome
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
Interventions
- DRUG Topical Nitroglycerine
- DRUG Topical Lidocaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2016-09 |
| Est. Completion | 2019-05-02 |
| Phase | Phase 4 |
What the finished NCT02832115 record still lists
NCT02832115 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Topical Nitroglycerine is the first listed.
NCT02832115 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02832115 about?
NCT02832115 is a clinical study titled "Topical Nitroglycerine Treatment for Radial Artery Spasm Prevention". The primary objective of the study is to determine the role of transdermal vasodilators as an adjunct to parenteral vasodilators in reducing radial artery spasm, improving patient comfort, and post procedure radial artery patency during transradial coronary angiograms and interventions. The study hy...
What is the current status of trial NCT02832115?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2016-09. Estimated completion is 2019-05-02.
What interventions are being tested in trial NCT02832115?
The interventions under investigation include: Topical Nitroglycerine (DRUG), Topical Lidocaine (DRUG).
Who is sponsoring clinical trial NCT02832115?
This trial is sponsored by Aultman Health Foundation, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02832115's enrollment target sits among peer trials
100 770th of 2000 higher than 1,148 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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