VM Medicalpark
Mersin, 33010, Turkey (Türkiye)
NCT Number: NCT06447688
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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Notify Me20 year and older
All sexes
Interventional
Phase 4
Mersin, 33010, Turkey (Türkiye)
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)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Prevent
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.
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.
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.
Time frame: During the procedure (from sheath insertion to procedure completion)
The volume of contrast media (in ml) used was recorded
Time frame: During the procedure (from sheath insertion to procedure completion)
The parameters collected for radiation exposure included the DAP
Time frame: During the procedure (from sheath insertion to procedure completion)
The parameters collected for radiation exposure included the fluoroscopy time (in minutes)
Mersin Medicalpark Hastanesi
Other
The Role of Oral Verapamil in Preventing Radial Spasm During Transradial Angiography
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