Topical Nitroglycerine Treatment for Radial Artery Spasm Prevention

NCT02832115 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2016.04.PG
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Radial Artery Spasm; Angina; Coronary Artery Disease

Keywords

Cardiac Catheterization; Vascular Access Site Complications; Vasodilator; Nitroglycerine; Lidocaine

Outcome Measures

Primary Outcomes (1)

• Radial Artery Spasm

  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

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

Secondary Outcomes (4)

• Change in Radial Artery Dimension Measured in mm^2.

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

• Number of Patients With Procedural Failure

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

• 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.

• Radial Pulse at End of Procedure

  At the end of transradial cardiac catheterization after sheath removal

Study Arms (2)

Study

EXPERIMENTAL

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.

Drug: Topical Nitroglycerine; Drug: Topical Lidocaine

Control

PLACEBO COMPARATOR

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.

Drug: Topical Lidocaine

Interventions

Topical Nitroglycerine DRUG

Topical nitroglycerine is applied to wrist prior to transradial cardiac catheterization to dilate radial artery and reduce spasm in study arm patients

Also known as: Vasodilation

Study

Topical Lidocaine DRUG

Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms

Also known as: Topical anesthetic

Control; Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 years or older
• Radial artery catheterization

You may not qualify if:

• Hypersensitivity or contraindication to lidocaine
• Hypersensitivity or contraindication to nitroglycerine
• Recent use of phosphodiesterase 5 inhibitors (\<24 hours after sildenafil or vardenafil; \<48 hours after tadalafil)
• Baseline weak radial pulse (0 or 1+)
• Baseline hypotension SBP \< 100 mmHg at the time of enrollment
• Dizziness or light-headedness at the time of enrollment
• Severe Aortic Stenosis or Hypertrophic obstructive cardiomyopathy
• Previous unknown bypass grafts or known left internal mammary graft
• Chest pain within 6 hours of IP administration
• More than 2 episodes of chest pain within 24 hours prior to IP administration
• Use of sublingual, transdermal, or intravenous nitroglycerine within 6 hours prior to IP administration
• Likely need for use of nitroglycerine for non-study indication
• Narcotic or sedative within 4 hours of enrollment
• Women who are suspected or known to be pregnant or breastfeeding

Sponsors & Collaborators

• Aultman Health Foundation: lead

Study Sites (1)

Aultman Hospital

Canton, Ohio, 44710, United States

Location

Related Publications (11)

• 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.

  PMID: 20453640 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.

  PMID: 14696161 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.

  PMID: 26604063 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.

  PMID: 22226169 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.

  PMID: 10348538 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.

  PMID: 23657175 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.

  PMID: 24461923 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.

  PMID: 22699036 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.

  PMID: 23582415 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.

  PMID: 18812349 BACKGROUND

MeSH Terms

Conditions

Angina Pectoris; Coronary Artery Disease

Interventions

Nitroglycerin; Vasodilation; Lidocaine; Anesthetics, Local

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

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

Results Point of Contact

• Title: Dr. Prabhakaran Gopalakrishnan
• Organization: Aultman Hospital

prab.gopalakrishnan@aultman.com

3304548076

Study Officials

• Prabhakaran Gopalakrishnan, MD

  Aultman Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prabhakaran Gopalakrishnan, MD

Study Record Dates

• First Submitted: June 26, 2016
• First Posted: July 14, 2016
• Study Start: September 1, 2016
• Primary Completion: May 2, 2019
• Study Completion: May 2, 2019
• Last Updated: October 27, 2020
• Results First Posted: October 27, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)