Clinical trial NCT06447688: The Role of Verapamil in Radial Artery Spasm
Official title: The Role of Oral Verapamil in Preventing Radial Spasm During Transradial Angiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Radial Artery Spasm
Keywords: radial artery spasm, verapamil, transradial access
Lead sponsor: Mersin Medicalpark Hastanesi
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Transradial arterial access (TRA) has several advantages over transfemoral access (TFA) for coronary angiography and percutaneous coronary intervention (PCI). These potential benefits include reduced risk of bleeding, patient comfort, early mobilization, early discharge, and associated reduced costs. In the European Society of Cardiology guidelines, radial intervention instead of femoral intervention is recommended as Class-1 in patients with Acute Coronary Syndrome.

Radial artery spasm (RAS) is defined as temporary, sudden narrowing of the radial artery. It is an important complication of radial access, which is common and can cause severe pain, and sometimes the procedure cannot be completed with radial access and causes a switch to femoral access.

The frequency of RAS varies between 6.8% and 30%. This rates decreased to 3.8% by intravenous administration of verapamil and nitroglycerin together.

To overcome RAS, various intraarterial and intravenous medications have been given, including calcium channel blockers and nitrates.

Calcium channel blockers such as verapamil and diltiazem has vasodilator effects by reducing the entry of calcium into vascular and arterial smooth muscle. Verapamil is a drug used sometimes alone and sometimes with other pharmacoagents to prevent RAS.

However, the effect of intravenous Verapamil is short-lived, and studies show that RAS develops despite intravenous administration of the drugs. This may be due to the short-term effect of intravenous verapamil and/or other agents.

In order to determine the dose and time of Verapamil to be given before angiography with TRA, investigators need to know the effective dose and transition time of verapamil into the blood.

Oral Verapamil's effect begins in 2 hours and reaches its peak effect in 5 hours. Therefore, Verapamil given orally 2 hours before the procedure can provide long-acting vasodilation during the coronary angiography with TRA procedure.

One study found that the effects of verapamil 120 mg 3 times daily were comparable to the effects of propranolol 100 mg 3 times daily in terms of a significant reduction in the frequency of angina and improved exercise tolerance. When only 40 mg of verapamil was used three times a day, no objective benefit was found in electrocardiographic findings despite significant subjective improvement.

Therefore, in our study, the prophylactic dose to be given to the patient was determined as 120 mg, and the time of administration was determined as 2 hours before coronary angiography.

Eligibility criteria: 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%).

Primary outcomes:
measure: Reduce percentage
timeFrame: during the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: VM Medicalpark
Study officials:
affiliation: Istinye University
name: Sefa Sural, MD
role: PRINCIPAL_INVESTIGATOR
References: