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The Role of Verapamil in Radial Artery Spasm

M

Mersin Medicalpark Hastanesi

Status and phase

Completed
Phase 4

Conditions

Radial Artery Spasm

Treatments

Drug: Verapamil

Study type

Interventional

Funder types

Other

Identifiers

NCT06447688
MLP-SSURAL-001

Details and patient eligibility

About

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.

Full description

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)

Enrollment

150 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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%).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
No other vasodilating drug such as nitrate will be given intravenously
Treatment:
Drug: Verapamil
Verapamil
Active Comparator group
Description:
Verapamil will be given orally at least 2 hours before angiography
Treatment:
Drug: Verapamil

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Sefa Sural; Döğen

Data sourced from clinicaltrials.gov

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