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IRCT20201028049181N4 IRCT 2026-07-06 Shahre-kord University of Medical Sciences Effect of forearm warming on reducing radial artery spasm and hand pain during coronary angiography Effect of Local Warming of forearm on reducing of pain and spasm of Radial Artery During Coronary Angiography: A Randomized Clinical Trial 2026-07-06 anticipated 118 Complete https://irct.ir/trial/91189 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, 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. N/A Radial artery spasm during coronary angiography. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is there is no further information
public Pedram Babaee
Unit 7, 1st Block (Right Side), Asatid Residential Complex, Shahrekord University of Medical Sciences Central Headquarters, Kashani St, Shahrekord
Shahrekord Iran (Islamic Republic of) 8365788157 +98 38 3222 5505 Pedram.babaee70@gmail.com Shahre-kord University of Medical Sciences scientific Pedram Babaee
Unit 7, 1st Block (Right Side), Asatid Residential Complex, Shahrekord University of Medical Sciences Central Headquarters, Kashani St., Shahrekord
Shahrekord Iran (Islamic Republic of) 8365788157 +98 38 3222 5505 Pedram.babaee70@gmail.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) 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. 18 years no limit Both 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) I73.9 Peripheral vascular disease, unspecified Prevention Prevention 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 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. 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. 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. 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. 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. 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. Shahre-kord University of Medical Sciences Approved 2026-06-23 Ethics committee of Shahrekord University of Medical Sciences Hajar Hospital, University Headquarters, Parastar St., Kashani Blvd. Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)