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Evaluation of the Efficacy of Combined Topical Gel of Verapamil, Nitroglycerin and Lidocain in Prevention of Radial Artery Spasm During Transradial Angiogplasty

Protocol summary

Study aim
In this study, the efficacy of combined topical gel of verapamil, nitroglycerin and lidocaine will be investigated in preventing radial artery spasm during angioplasty via radial artery.
Design
Randomized, two-blinded, parallel, placebo-controlled clinical trial with 64 patients in each group.
Settings and conduct
This two blind study will be done in Tehran Heart Center. Health care providers and patients are blind. Patients fall into two groups using block randomization. One group received placebo gel and other received therapeutic gel. The basal diameter of radial artery is measured with ultrasound. 0.5 to 1 hour before process, the therapeutic or the placebo gel are applied on the radial artery pulse, and then covered with a transparent dressing. After removing the gel, the radial artery diameter is measured with ultrasound before process beginning. During PCI, following parameters is recorded: Sedative drug and its dose, Sheath insertion in one or more attempts, Wire passage in one or more attempts, Vasodilator parenteral cocktail used, Sympathetic system response, Radial artery spasm score, Patient forearm pain. After performing PCI, radial artery is reevaluated with ultrasound.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age older than 18 years old Radial elective PCI candidates Exclusion criteria: Hypersensitivity or contraindication to lidocaine Hypersensitivity or contraindication to nitroglycerin Baseline weak radial pulse Inadequate blood supply to palm Presence of artriovenous fistula for dialysis Pregnant women or nursing mothers
Intervention groups
Intervention group: Combined Topical Gel of Verapamil, Nitroglycerin and Lidocain will be applied before PCI. Control group: Placebo gel will be applied before PCI.
Main outcome variables
Radial artery spasm؛ Change in Radial artery diameter

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200128046296N1
Registration date: 2020-03-21, 1399/01/02
Registration timing: prospective

Last update: 2020-03-21, 1399/01/02
Update count: 0
Registration date
2020-03-21, 1399/01/02
Registrant information
Name
Sevda Mikaeili Mirak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3252 5056
Email address
sevda.mikaeili.m@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-04, 1399/01/16
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Efficacy of Combined Topical Gel of Verapamil, Nitroglycerin and Lidocain in Prevention of Radial Artery Spasm During Transradial Angiogplasty
Public title
Evaluation of the Efficacy of Combined Topical Gel of Verapamil, Nitroglycerin and Lidocain in Prevention of Radial Artery Spasm Incidence
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 18 years or older Elective radial PCI candidates
Exclusion criteria:
Hypersensitivity or contraindication to lidocaine Hypersensitivity or contraindication to nitroglycerin Baseline weak radial pulse Inadequate blood supply to palm Presence of arteriovenous fistula for dialysis Pregnant women or nursing mothers
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 128
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method of this study is permuted block randomization individually. The randomized list of numbers 1 to 128 is randomly divided into two groups A or B, and the admitted patients are listed in group A or B, respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a two blind clinical trial conducted at Tehran Heart Center. Patients fall into two groups using block randomization. One group received placebo gel and other received therapeutic gel.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
0
Approval date
2020-01-18, 1398/10/28
Ethics committee reference number
IR.TUMS.VCR.REC.1398.807

Health conditions studied

1

Description of health condition studied
Chronic Coronary Syndrome
ICD-10 code
I20
ICD-10 code description
Angina pectoris

Primary outcomes

1

Description
Radial artery diameter
Timepoint
Before gel application and just after
Method of measurement
Radial artery ultrasound

2

Description
Radial artery spasm
Timepoint
During angioplasty
Method of measurement
Radial artery spasm score: A) Verbal or nonverbal expression of discomfort in the forearm during catheter/sheath manipulation: Absent: 0; Present: 1; B) Difficulty in manipulating the catheter: Absent: 0; Present: 1; C) Difficulty in sheath removal: Absent: 0; Present: 1; D) Additional use of intraarterial nitroglycerine or verapamil after the initial vasodilator cocktail for suspected radial artery spasm: No: 0; Yes: 1. Incidence of radial artery spasm indicated by a Radial artery spasm score of 1 or more.

3

Description
Patient pain
Timepoint
After sheath insertion during angioplasty
Method of measurement
Visual analoug scale and verbal scale of pain

4

Description
Sympathetic system response
Timepoint
Before angioplasty and then after
Method of measurement
Measuring of systolic blood pressure, diastolic blood pressure and heart rate

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 1 gram of therapeutic gel is applied to the wrist overlying radial pulse (centered approximately 1 cm proximal to the radial styloid process) at least half an hour before arterial puncture.
Category
Prevention

2

Description
Control group: 1 gram of placebo gel is applied to the wrist overlying radial pulse (centered approximately 1 cm proximal to the radial styloid process) at least half an hour before arterial puncture.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Azita Hajhossein Talasaz
Street address
North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
0
Phone
+98 21 8802 9600
Email
sevda.mikaeili.m@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
16 Azar Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1692
Email
sevda.mikaeili.m@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azita Hajhossein Talasaz
Position
Aََssistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Pharmacy
Street address
Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1692
Email
atalasaz@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azita Hajhossein Talasaz
Position
Aََssistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Pharmacy
Street address
Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1692
Email
atalasaz@razi.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sevda Mikaeili Mirak
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 2, Homa Alley, South Jamalzadeh Ave.
City
Tehran
Province
Tehran
Postal code
1313815435
Phone
+98 21 6691 6847
Email
sevda.mikaeili.m@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data like PCI check list and effects of therapeutic gel will be published in form of article
When the data will become available and for how long
At the end of study and after publication
To whom data/document is available
Scientific researchers
Under which criteria data/document could be used
For more researches
From where data/document is obtainable
Azita Hajhossein Talasaz
What processes are involved for a request to access data/document
After acceptance by Azita Hajhossein Talasaz
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