Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447688
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-05-31
Brief Title:
Does Verapamil Given Orally Prevent Radial Artery Spasm During Transradial Coronary Angiography
Sponsor:
Mersin Medicalpark Hastanesi
Organization:
Mersin Medicalpark Hastanesi
Study Overview
Official Title:
Does Verapamil Given Orally Prevent Radial Artery Spasm During Transradial Coronary Angiography
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 68 and 30 This rates decreased to 38 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 andor 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 Verapamils 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
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 68 and 30 This rates decreased to 38 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 andor 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 Verapamils 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None