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Completed

NCT Number: NCT06447688

The Role of Verapamil in Radial Artery Spasm

Coronary angiography (CAG) is an invasive imaging method performed to determine the degree of coronary artery disease. Radial artery spasm (RAS) is one of the most common complications during coronary angiography performed via the transradial approach, causing patient discomfort or sometimes interrupting the procedure. There are many studies on RAS, and various pharmacoagents administered intravenously (intraarterial) to prevent RAS have been described. However, there is limited data in the literature regarding oral pharmacoagents that will prevent this complication. In our study, the preventive effect of Verapamil, given orally 2 hours before coronary angiography, on radial artery spasm will be investigated.

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Key information

Conditions

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

VM Medicalpark

Mersin, 33010, Turkey (Türkiye)

About this study

Transradial access (TRA) has emerged as the preferred modality for vascular access in coronary interventions worldwide, prompting growing interest in its potential applications across other interventional specialties, especially in neurovascular procedures. Radial artery spasm (RAS) remains the most common complication of TRA, often causing procedural difficulties, patient discomfort, and an increased risk of access site crossover. The incidence of radial artery spasm reported in the literature varies widely, with estimates ranging from 4% to over 51.3%, influenced by factors such as definitions, patient selection, and the operator's experience.

After puncturing the radial artery (Puncture-induced RAS) and inserting the sheath-but before administering intra-arterial spasmolytics-local discomfort and pain may trigger a sympathetic vasoconstrictive response, potentially leading to the onset of RAS.

A previous study has stated that preventing RAS is more effective than treating it after it has been established. In this context, we will conduct a randomized controlled trial to evaluate the efficacy of 120 mg of oral verapamil administered two hours before radial artery puncture in reducing the incidence of radial artery spasm (RAS)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who undergo daily coronary angiography
  • Whose Allen test is normal.
  • Must be able to swallow tablets

Exclusion criteria

  • Allen test results are distorted,
  • No pulse in the radial artery,
  • Patients who have previously undergone radial angiography and whose hemodynamics are compromised will be excluded from the study.
  • Patients with known contraindications to verapamil (significant aortic stenosis, heart rate <50/min, high-grade atrioventricular block, myocardial infarction) complicated with cardiogenic shock, or left ventricular ejection fraction <35%).

Treatment and study plan

Verapamil

Drug

Prevent

Primary outcomes

  1. Number of Participants With Clinical Radial Artery Spasm (RAS)

    Time frame: During the coronary angiography procedure (up to 2 hours from sheath insertion)

    Clinical RAS defined as presence of at least 2 of the following: (1) forearm pain ≥ 4/10, (2) pain during catheter manipulation, (3) catheter movement restriction, (4) pain during sheath removal, (5) difficulty in sheath removal.

  2. Number of Participants With Ultrasonographically Confirmed Radial Artery Spasm (Ultrasonographic RAS)

    Time frame: During the procedure, immediately after catheterization (within 2 hours)

    Radial artery spasm (RAS) was defined as luminal narrowing of ≥50% as measured by ultrasonography at the access site.

Secondary outcomes

  1. Number of Participants With Procedural Success

    Time frame: During the procedure (from sheath insertion to procedure completion)

    Procedure success was defined as completing coronary angiography or PCI using the initial radial artery approach without requiring a switch to an alternative access site.

  2. Mean Volume of Contrast Media Used (mL) (mL)

    Time frame: During the procedure (from sheath insertion to procedure completion)

    The volume of contrast media (in ml) used was recorded

  3. Mean of the Dose Area Product (DAP)

    Time frame: During the procedure (from sheath insertion to procedure completion)

    The parameters collected for radiation exposure included the DAP

  4. Mean of the Fluoroscopy Time

    Time frame: During the procedure (from sheath insertion to procedure completion)

    The parameters collected for radiation exposure included the fluoroscopy time (in minutes)

Sponsors and collaborators

Lead sponsor

Mersin Medicalpark Hastanesi

Other

Registry information

Official study title

The Role of Oral Verapamil in Preventing Radial Spasm During Transradial Angiography

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 7, 2024
Registry last updated
Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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