Randomized Comparison of Radiation Exposure to Operators in Coronary Intervention Between Right Radial and Left DRA

Radiation Exposure Clinical Trial

— DOSE  

Official title:

Comparison of raDiatiOn Exposure to Operators in Coronary Angiography and Percutaneous Coronary Intervention Between Right Conventional and Left Distal Radial artEry Approach: A Single-Center, Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05702060
• Other study ID #: 9-2022-0141
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2023
• Est. completion date: December 5, 2025

Study information

• Verified date: March 2024
• Source: Yonsei University
• Contact: Yongcheol Kim, MD, PhD
• Phone: +823151898967
• Email: yongcheol[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to show that the radiation exposure of the left distal radial artery approach is superior to the conventional right radial artery approach in terms of less radiation exposure.

Description:

The conventional radial approach is now recognized as the basic technique in coronary artery surgery. Compared to the femoral artery access, the main advantage is the increased stability due to the reduction of massive bleeding. Due to these advantages, recent guidelines recommend the conventional radial approach as the basic approach for all acute myocardial infarction (AMI) cases with or without ST-segment elevation. In particular, in the case of ST-segment elevation myocardial infarction (STEMI), new antiplatelet agents such as Ticagrelor and Prasugrel and strong antiplatelet agents such as Glycoprotein inhibitors have been used to prevent major vascular complications. For these many operators, primary percutaneous coronary intervention (PCI) through the radial artery is recommended. At this time, the operator prefers the right radial artery approach because of the comfort of performing the procedure on the patient's right side. However, the operator sometimes has to substitute the left radial artery or femoral artery access due to difficulty in manipulating the catheter due to severe tortuousness of the right subclavian artery. Although the left radial artery approach requires less operation time and radiographic imaging time due to less tortuousness of the left subclavian artery, the right conventional radial approach is still preferred due to the ergonomic inconvenience of having to lean toward the patient. Patients undergoing coronary angiography (CAG) were randomly assigned to the left snuffbox approach and the right conventional radial approach, and the surgeons' radiation exposure between the two approaches was evaluated and compared.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1010
• Est. completion date: December 5, 2025
• Est. primary completion date: December 5, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Patients aged 20 years or older

2. Patients scheduled for coronary angiography and intervention

Exclusion Criteria:

1. When the pulse of the Left distal radial artery cannot be palpated

2. When the pulse of the right conventional radial artery cannot be palpated

3. In case of arteriovenous fistula

4. Acute myocardial infarction (AMI) patients

5. In case femoral artery access must be performed (state of shock, etc.)

6. In case of atrioventricular block

7. When an ergonovine provocation test is required

8. When the patient refuses to consent to the study

Related Conditions & MeSH terms

• Radiation Exposure

Intervention

Procedure:
• Radial Artery Puncture Method for Coronary Angiography and Intervention
Radial Artery Puncture Method for Coronary Angiography and Intervention

Locations

Country	Name	City	State
Korea, Republic of	Yongcheol Kim	Yongin	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Yonsei University	Myung In Pharm

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation exposure examination	Radiation exposure for surgeons in the case of the left distal radial artery approach and the right radial artery approach, respectively	Through procedure completion, up to 24 hours
Secondary	Fluoroscopy time	Fluoroscopy time	Through procedure completion, up to 24 hours
Secondary	Corrected by X-ray dose Radiation exposure of surgeons	Corrected by X-ray dose Radiation exposure of surgeons	Through procedure completion, up to 24 hours
Secondary	Corrected by X-ray dose Radiation	Corrected by X-ray dose Radiation	Through procedure completion, up to 24 hours
Secondary	Hemostasis time	Hemostasis time	Through procedure completion, up to 24 hours
Secondary	Procedure success rate	Procedure success rate	Through procedure completion, up to 24 hours
Secondary	Amount of contrast agent used	Amount of contrast agent used	Through procedure completion, up to 24 hours