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Topical Nitroglycerine Treatment for Radial Artery Spasm Prevention (TNT-RASP)

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ClinicalTrials.gov Identifier: NCT02832115
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Prabhakaran Gopalakrishnan, Aultman Health Foundation

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.

Condition or disease Intervention/treatment Phase
Radial Artery Spasm Angina Coronary Artery Disease Drug: Topical Nitroglycerine Drug: Topical Lidocaine Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Topical Nitroglycerine Treatment for Radial Artery Spasm Prevention
Actual Study Start Date : September 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Cramps

Arm Intervention/treatment
Experimental: Study
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
Topical nitroglycerine is applied to wrist prior to transradial cardiac catheterization to dilate radial artery and reduce spasm in study arm patients

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

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




Primary Outcome Measures :
  1. Radial artery spasm [ Time Frame: During transradial cardiac catheterization ]

    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 Outcome Measures :
  1. Change in Radial artery dimension measured in mm. [ Time Frame: Application of nitroglycerine / placebo until prior to arterial puncture ]
    Change in Radial artery dimension in mm- Before application of topical nitroglycerine / placebo (Pre dilation) vs Prior to arterial puncture after application of topical nitroglycerine / placebo (Post-dilation)

  2. Procedural failure [ Time Frame: During transradial cardiac catheterization ]
    Need to abort procedure or convert to transfemoral access

  3. Patient discomfort or pain during procedure (Visual analog scale 0-10) [ Time Frame: During transradial cardiac catheterization ]
    Patient discomfort or pain during procedure measured using Visual analog scale 0-10

  4. Radial pulse at end of procedure [ Time Frame: At the end of transradial cardiac catheterization after sheath removal ]
    Radial pulse at end of procedure 0- 4+



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: 18 years or older
  2. Radial artery catheterization

Exclusion Criteria:

  1. Hypersensitivity or contraindication to lidocaine
  2. Hypersensitivity or contraindication to nitroglycerine
  3. Recent use of PDE5 inhibitors (<24 hours after sildenafil or vardenafil; <48 hours after tadalafil)
  4. Baseline weak radial pulse (0 or 1+)
  5. Baseline hypotension SBP < 100mmHg at the time of enrollment
  6. Dizziness or light-headedness at the time of enrollment
  7. Severe Aortic Stenosis or HOCM
  8. Previous unknown bypass grafts or known LIMA graft
  9. Chest pain within 6 hours of IP administration
  10. More than 2 episodes of chest pain within 24 hours prior to IP administration
  11. Use of sublingual, transdermal, or intravenous nitroglycerine within 6 hours prior to IP administration
  12. Likely need for use of nitroglycerine for non-study indication
  13. Narcotic or sedative within 4 hours of enrollment
  14. Women who are suspected or known to be pregnant or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832115


Contacts
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Contact: Prabhakaran Gopalakrishnan, MD 972-310-8206 prab.gopalakrishnan@aultman.com

Locations
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United States, Ohio
Aultman Hospital Recruiting
Canton, Ohio, United States, 44710
Contact: Prabhakaran Gopalakrishnan, MD    972-310-8206    prab.gopalakrishnan@aultman.com   
Contact: Mary K Amos, RN    330-363-4162    mary.amos@aultman.com   
Sponsors and Collaborators
Aultman Health Foundation

Publications of Results:
Frangosa C, & Nobleb S. How to transform you into a radialist: tips and tricks. Cardiovascular Medicine 14.10 (2011): 315-24.

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Responsible Party: Prabhakaran Gopalakrishnan, Prabhakaran Gopalakrishnan, MD, Aultman Health Foundation
ClinicalTrials.gov Identifier: NCT02832115     History of Changes
Other Study ID Numbers: 2016.04.PG
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Prabhakaran Gopalakrishnan, Aultman Health Foundation:
Radial Artery Spasm
Cardiac Catheterization
Vascular Access Site Complications
Vasodilator
Nitroglycerine
Lidocaine

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Spasm
Muscle Cramp
Peripheral Vascular Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Lidocaine
Nitroglycerin
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action