Topical Nitroglycerine Treatment for Radial Artery Spasm Prevention
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.
Timeline
- Start
- 2016-09
- Primary completion
- 2019-05-02
- Completion
- 2019-05-02
Publications
- Background Siudak Z, Zawislak B, Dziewierz A, Rakowski T, Jakala J, Bartus S, Noworolnik B, Zasada W, Dubiel JS, Dudek D. Transradial approach in patients with ST-elevation myocardial infarction treated with abciximab results in fewer bleeding complications: data from EUROTRANSFER registry. Coron Artery Dis. 2010 Aug;21(5):292-7. doi: 10.1097/MCA.0b013e32833aa6d1.
- Background Hildick-Smith DJ, Walsh JT, Lowe MD, Shapiro LM, Petch MC. Transradial coronary angiography in patients with contraindications to the femoral approach: an analysis of 500 cases. Catheter Cardiovasc Interv. 2004 Jan;61(1):60-6. doi: 10.1002/ccd.10708.
- Background Azzalini L, Tosin K, Chabot-Blanchet M, Avram R, Ly HQ, Gaudet B, Gallo R, Doucet S, Tanguay JF, Ibrahim R, Gregoire JC, Crepeau J, Bonan R, de Guise P, Nosair M, Dorval JF, Gosselin G, L'Allier PL, Guertin MC, Asgar AW, Jolicoeur EM. The Benefits Conferred by Radial Access for Cardiac Catheterization Are Offset by a Paradoxical Increase in the Rate of Vascular Access Site Complications With Femoral Access: The Campeau Radial Paradox. JACC Cardiovasc Interv. 2015 Dec 21;8(14):1854-64. doi: 10.1016/j.jcin.2015.07.029. Epub 2015 Nov 18.
- Background Ho HH, Jafary FH, Ong PJ. Radial artery spasm during transradial cardiac catheterization and percutaneous coronary intervention: incidence, predisposing factors, prevention, and management. Cardiovasc Revasc Med. 2012 May-Jun;13(3):193-5. doi: 10.1016/j.carrev.2011.11.003. Epub 2012 Jan 5.
- Background Saito S, Ikei H, Hosokawa G, Tanaka S. Influence of the ratio between radial artery inner diameter and sheath outer diameter on radial artery flow after transradial coronary intervention. Catheter Cardiovasc Interv. 1999 Feb;46(2):173-8. doi: 10.1002/(SICI)1522-726X(199902)46:23.0.CO;2-4.
- Background Ercan S, Unal A, Altunbas G, Kaya H, Davutoglu V, Yuce M, Ozer O. Anxiety score as a risk factor for radial artery vasospasm during radial interventions: a pilot study. Angiology. 2014 Jan;65(1):67-70. doi: 10.1177/0003319713488931. Epub 2013 May 8.
- Background Kotowycz MA, Johnston KW, Ivanov J, Asif N, Almoghairi AM, Choudhury A, Nagy CD, Sibbald M, Chan W, Seidelin PH, Barolet AW, Overgaard CB, Dzavik V. Predictors of radial artery size in patients undergoing cardiac catheterization: insights from the Good Radial Artery Size Prediction (GRASP) study. Can J Cardiol. 2014 Feb;30(2):211-6. doi: 10.1016/j.cjca.2013.11.021. Epub 2013 Nov 23.
- Background Frangosa C, & Nobleb S. How to transform you into a radialist: tips and tricks. Cardiovascular Medicine 14.10 (2011): 315-24.
- Background Majure DT, Hallaux M, Yeghiazarians Y, Boyle AJ. Topical nitroglycerin and lidocaine locally vasodilate the radial artery without affecting systemic blood pressure: a dose-finding phase I study. J Crit Care. 2012 Oct;27(5):532.e9-13. doi: 10.1016/j.jcrc.2012.04.019. Epub 2012 Jun 12.
- Background Beyer AT, Ng R, Singh A, Zimmet J, Shunk K, Yeghiazarians Y, Ports TA, Boyle AJ. Topical nitroglycerin and lidocaine to dilate the radial artery prior to transradial cardiac catheterization: a randomized, placebo-controlled, double-blind clinical trial: the PRE-DILATE Study. Int J Cardiol. 2013 Oct 3;168(3):2575-8. doi: 10.1016/j.ijcard.2013.03.048. Epub 2013 Apr 10.
- Background Yoshizaki T, Tabuchi N, Toyama M. Verapamil and nitroglycerin improves the patency rate of radial artery grafts. Asian Cardiovasc Thorac Ann. 2008 Oct;16(5):396-400. doi: 10.1177/021849230801600511.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | nitroglycerine | Unknown | 30 mg | Topical |
| Background | Lidocaine | Other / unclassified | 40 mg | Topical |