The Role of Verapamil in Radial Artery Spasm

NCT06447688 — Phase 4, Completed, 150 participants, Mersin Medicalpark Hastanesi

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

RegistryNCT06447688
StatusCompleted
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: none, prevention
Enrollment150 (Actual)
SponsorMersin Medicalpark Hastanesi (Other)
ConditionsRadial Artery Spasm
InterventionsVerapamil (Drug)
Datesstart 2024-06-05, primary completion 2024-11-01, completion 2024-11-15, first posted 2024-06-07, last updated 2025-10-10
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Radial Artery Spasm All trials of Verapamil

-Summary

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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+Detailed 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)

+Arms and interventions

ArmTypeInterventionsDescription
PlaceboPlacebo comparatorDrug: VerapamilNo other vasodilating drug such as nitrate will be given intravenously
VerapamilActive comparatorDrug: VerapamilVerapamil will be given orally at least 2 hours before angiography
  • Verapamil (Drug): Prevent

+Outcome measures

Primary outcomes

  • Number of Participants With Clinical Radial Artery Spasm (RAS) [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.
  • Number of Participants With Ultrasonographically Confirmed Radial Artery Spasm (Ultrasonographic RAS) [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

  • Number of Participants With Procedural Success [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.
  • Mean Volume of Contrast Media Used (mL) (mL) [During the procedure (from sheath insertion to procedure completion)]: The volume of contrast media (in ml) used was recorded
  • Mean of the Dose Area Product (DAP) [During the procedure (from sheath insertion to procedure completion)]: The parameters collected for radiation exposure included the DAP
  • Mean of the Fluoroscopy Time [During the procedure (from sheath insertion to procedure completion)]: The parameters collected for radiation exposure included the fluoroscopy time (in minutes)

+Eligibility

Sex: All, ages: 20 Years to any

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%).

+Posted results

Participant flow

MilestonePlaceboVerapamil
Started7575
Completed7575
Not completed00

Outcome results

  • Number of Participants With Clinical Radial Artery Spasm (RAS) (Primary), Number, participants: Placebo 23; Verapamil 3
  • Number of Participants With Ultrasonographically Confirmed Radial Artery Spasm (Ultrasonographic RAS) (Primary), Number, participants: Placebo 36; Verapamil 8
  • Number of Participants With Procedural Success (Secondary), Number, participants: Placebo 75; Verapamil 75
  • Mean Volume of Contrast Media Used (mL) (mL) (Secondary), Mean, Milliliters (mL): Placebo 133.8 +/- 71.9; Verapamil 136.4 +/- 78.3
  • Mean of the Dose Area Product (DAP) (Secondary), Mean, Gy·cm2: Placebo 873.9 +/- 732.3; Verapamil 878.8 +/- 736.7
  • Mean of the Fluoroscopy Time (Secondary), Mean, minute: Placebo 7.9 +/- 7.3; Verapamil 6.9 +/- 5.8

Adverse events

Time frame: From procedure initiation through hospital discharge (average 1 day)

ArmDeathsSerious adverse eventsOther adverse events
Placebo0/75 (0.0%)0/75 (0.0%)0/75 (0.0%)
Verapamil0/75 (0.0%)0/75 (0.0%)0/75 (0.0%)

+Locations (1)

FacilityCityCountryStatus
VM MedicalparkMersinTurkey (Türkiye)

+Publications

  • Results publication: Sural S, Dogen ME, Duzel B, Karaca O, Brilakis ES, Gorgulu S. The Role of Oral Verapamil in Preventing Radial Spasm During Transradial Angiography. Catheter Cardiovasc Interv. 2025 Aug;106(2):1247-1254. doi: 10.1002/ccd.31675. Epub 2025 Jun 8. PMID 40485154

+Study documents

+Investigators