Conducted at the Cath Lab of Hajar Hospital, Shahrekord University of Medical Sciences. This is an open-label (unblinded) study.
Participants/Inclusion and exclusion criteria
Age > 18 years; candidates for right transradial coronary angiography (stable CAD or stable NSTEMI/UA); SBP >100 mmHg; stable cardiac rhythm.
Exclusion: Severe heart failure; active STEMI; history of right upper extremity surgery, trauma, or prior transradial angiography; unstable arrhythmia; coagulation disorders.
Intervention groups
Intervention Group: Local forearm warming (5–10 minutes, reaching 37.5°C–37.9°C) before puncture, combined with a 200 mcg intra-arterial nitroglycerin injection.
Control Group: Routine standard care combined with a 200 mcg intra-arterial nitroglycerin injection.
Main outcome variables
Primary: Incidence and severity of radial artery spasm (RAS) evaluated via the 4-grade Rathore score.
Secondary: Procedural pain severity (VAS score), vital signs fluctuations (SBP, DBP, HR, SpO2), requirement for supplementary medications, access-site crossover rate to the femoral artery,vasovagal rate and overall patient satisfaction.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201028049181N4
Registration date:2026-07-06, 1405/04/15
Registration timing:registered_while_recruiting
Last update:2026-07-06, 1405/04/15
Update count:0
Registration date
2026-07-06, 1405/04/15
Registrant information
Name
Pedram Babaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3441 1076
Email address
pedram.babaee70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-07-06, 1405/04/15
Expected recruitment end date
2026-09-06, 1405/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Local Warming of forearm on reducing of pain and spasm of Radial Artery During Coronary Angiography: A Randomized Clinical Trial
Public title
Effect of forearm warming on reducing radial artery spasm and hand pain during coronary angiography
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged age 18 years old
Candidates for diagnostic coronary angiography or elective/emergency uncomplicated percutaneous coronary intervention (PCI) via transradial access
Patients with stable coronary artery disease (Stable CAD) or uncomplicated non-ST-elevation myocardial infarction / unstable angina (NSTEMI/UA)
Systolic blood pressure > 100mmHg
Normal sinus rhythm or stable asymptomatic arrhythmias.
Ability to provide written informed consent.
not given any inter-arterial vasodilator before starting angiography
Feasibility of using the right radial artery based on clinical examination and standard or modified Allen's test.
Exclusion criteria:
Severe heart failure with NYHA functional class III or IV
Acute myocardial infarction (Acute MI) including active STEMI or active NSTEMI at the time of presentation.
History of traumatic injury or significant surgery in the right upper extremity that has disrupted the anatomy or function of the radial artery.
History of previous angiography or intervention via the right radial artery
Known coagulation disorders or consumption of medications with a high risk of bleeding, based on the investigator's judgment
Inability of the patient to cooperate or failure to obtain informed consent
Any concurrent clinical condition that, in the opinion of the principal investigator, affects patient safety or the validity of the study data
Pregnancy or lactation.
Systolic blood pressure < 100 mmHg
Symptomatic bradycardia (HR < 50 bpm)
Unstable arrhythmia (such as AF with uncontrolled RVR, Complete heart block, or VT)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
118
Randomization (investigator's opinion)
Randomized
Randomization description
To prevent disruption in the routine workflow of the angiography unit and to minimize staff confusion, patient assignment is conducted using a time-based allocation method. On predefined days of the week, all eligible patients enrolled on that specific day receive a designated intervention. For instance, patients presenting on Mondays are assigned to the control group (receiving nitroglycerin), while patients presenting on Wednesdays are assigned to the intervention group (receiving nitroglycerin and local forearm warming). This allocation scheme remains fixed throughout the entire study period, and an equal ratio of patients between the two groups is maintained based on the number of sessions.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Hajar Hospital, University Headquarters, Parastar St., Kashani Blvd.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Approval date
2026-06-23, 1405/04/02
Ethics committee reference number
IR.SKUMS.MED.REC.1405.085
Health conditions studied
1
Description of health condition studied
Radial artery spasm during coronary angiography
ICD-10 code
I73.9
ICD-10 code description
Peripheral vascular disease, unspecified
Primary outcomes
1
Description
Incidence and grade of radial artery spasm during the transradial coronary angiography
Timepoint
From the moment of catheter insertion until the end of the procedure
Method of measurement
The operator assesses radial artery spasm based on the occurrence of at least one of the following criteria: 1) Clear arm pain with a Visual Analogue Scale score greater than or equal to 4, 2) Confirmed mechanical resistance during catheter movement, 3) Need for additional intra-arterial vasodilators, 4) Need to convert access site from radial to femoral due to spasm
Secondary outcomes
1
Description
Comparison of hemodynamic changes, including systolic blood pressure, diastolic blood pressure, heart rate, and blood oxygen saturation among the two study groups.
Timepoint
Measured at baseline (before drug injection), at the 1st minute, 5th minute, and then every 5 minutes until the end of the procedure, continuing up to 30 minutes after the start of angiography.
Method of measurement
Monitored and recorded using a standard patient monitoring device in the angiography suite. Systolic and diastolic blood pressures are measured in millimeters of mercury, heart rate in beats per minute, and blood oxygen saturation as a percentage via continuous pulse oximetry.
2
Description
Incidence of vasovagal reactions during the transradial procedure.
Timepoint
From the beginning of the catheterization until 5-10 minutes
Method of measurement
Diagnosed based on clinical symptoms and hemodynamic changes, including symptomatic hypotension (a decrease in systolic blood pressure of 20 mmHg or more compared to baseline) or symptomatic bradycardia, accompanied by symptoms such as sweating or nausea.
3
Description
Evaluation of the access-site crossover rate from radial to femoral artery access due to radial artery spasm
Timepoint
From the beginning of the catheterization procedure until its completion.
Method of measurement
Calculated as the percentage of patients in each treatment group who require switching the access site to the femoral artery due to severe or refractory radial artery spasm.
4
Description
Assessment of procedural pain intensity during the transradial procedure.
Timepoint
Immediately after the completion of the procedure, recording the overall pain experienced throughout the entire procedure.
Method of measurement
Pain intensity is measured using a 10-centimeter Visual Analogue Scale, where a score of 0 represents "no pain" and a score of 10 represents the "worst possible pain". The score is recorded based on the patient's self-report by a trained independent assessor.
Intervention groups
1
Description
Control group: Intra-arterial drug injection: Tng 200ug from a 5mg/5cc vial from Caspian Tamin Company. This drug is injected after the start of angiography
Category
Prevention
2
Description
Intervention group:Warming the forearm with a non-contact warmer for 5-10 minutes after sterilizing the hands along with intra-arterial drug injection: Tng 200ug from a 5mg/5cc vial from Caspian Tamin Company. This drug is injected after inserting the radial sheet.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital of Shahrekord Univesity of medical sciences
Full name of responsible person
Pedram Babaee
Street address
Parastar street, Kashani street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 913 830 8506
Email
pedram.babaee70@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Ali Hassanpour
Street address
Building No. 2; University Headquarters; Kashani Blvd.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
research@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Pedram Babaee
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Unit 7, 1st Block (Right Side), Asatid Residential Complex, Shahrekord University of Medical Sciences Central Headquarters, Kashani St, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8365788157
Phone
+98 38 3222 5505
Fax
Email
Pedram.babaee70@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Pedram Babaee
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Unit 7, 1st Block (Right Side), Asatid Residential Complex, Shahrekord University of Medical Sciences Central Headquarters, Kashani St., Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8365788157
Phone
+98 38 3222 5505
Fax
Email
Pedram.babaee70@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Pedram Babaee
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Unit 7, 1st Block (Right Side), Asatid Residential Complex, Shahrekord University of Medical Sciences Central Headquarters, Kashani St., Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8365788157
Phone
+98 38 3222 5505
Fax
Email
Pedram.babaee70@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available